United States · drugs and devices

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New 578

DUPIXENT — Weight increased
No rationale yet.
10/09/2026
DUPIXENT — Sacral pain
No rationale yet.
10/09/2026
DUPIXENT — Skin exfoliation
No rationale yet.
10/09/2026
DUPIXENT — Pruritus
No rationale yet.
10/09/2026
DUPIXENT — Dry skin
No rationale yet.
10/09/2026
TALTZ — Psoriasis
No rationale yet.
10/09/2026
DUPIXENT — Exposure via skin contact
No rationale yet.
10/09/2026
DUPIXENT — Accidental exposure to product
No rationale yet.
10/09/2026
LANTUS — Product storage error
No rationale yet.
10/09/2026
TYSABRI — Ovarian cancer
No rationale yet.
10/09/2026
DAPAGLIFLOZIN — Hypertension
No rationale yet.
10/09/2026
DAPAGLIFLOZIN — Lung disorder
No rationale yet.
10/09/2026
DAPAGLIFLOZIN — Renal disorder
No rationale yet.
10/09/2026
DAPAGLIFLOZIN — General physical health deterioration
No rationale yet.
10/09/2026
DAPAGLIFLOZIN — Diabetes mellitus
No rationale yet.
10/09/2026
DAPAGLIFLOZIN — Cardiac disorder
No rationale yet.
10/09/2026
SIMPONI — Device defective
No rationale yet.
10/09/2026
SIMPONI — Device leakage
No rationale yet.
10/09/2026
SPRAVATO — Condition aggravated
No rationale yet.
10/09/2026
SPRAVATO — Feeling of relaxation
No rationale yet.
10/09/2026
LETYBO — Therapy non-responder
No rationale yet.
10/09/2026
TREMFYA — Surgery
No rationale yet.
10/09/2026
TREMFYA — Infection
No rationale yet.
10/09/2026
TREMFYA — Multimorbidity
No rationale yet.
10/09/2026
TREMFYA — Inflammatory bowel disease
No rationale yet.
10/09/2026
VYEPTI — Migraine
No rationale yet.
10/09/2026
NEMLUVIO — Foot fracture
No rationale yet.
10/09/2026
SKYRIZI — Adverse drug reaction
No rationale yet.
10/09/2026
SKYRIZI — Drug hypersensitivity
No rationale yet.
10/09/2026
LETYBO — Off label use
No rationale yet.
10/09/2026
LETYBO — Drug effect less than expected
No rationale yet.
10/09/2026
ALYMSYS — Neoplasm progression
No rationale yet.
10/09/2026
WEGOVY — Device malfunction
No rationale yet.
10/09/2026
WEGOVY — Drug dose omission by device
No rationale yet.
10/09/2026
WEGOVY — Device leakage
No rationale yet.
10/09/2026
WEGOVY — Scratch
No rationale yet.
10/09/2026
NEMLUVIO — Product dose omission issue
No rationale yet.
10/09/2026
AIRSUPRA — Device malfunction
No rationale yet.
10/09/2026
AIRSUPRA — Product dose omission issue
No rationale yet.
10/09/2026
JARDIANCE — Mobility decreased
No rationale yet.
10/09/2026
JARDIANCE — Decreased appetite
No rationale yet.
10/09/2026
JARDIANCE — Malaise
No rationale yet.
10/09/2026
JARDIANCE — Acute kidney injury
No rationale yet.
10/09/2026
JARDIANCE — Altered state of consciousness
No rationale yet.
10/09/2026
JARDIANCE — Hypoglycaemia
No rationale yet.
10/09/2026
JARDIANCE — Dehydration
No rationale yet.
10/09/2026
VABYSMO — Eye irritation
No rationale yet.
10/09/2026
VABYSMO — Vision blurred
No rationale yet.
10/09/2026
Balloon Catheter — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
Allura Xper FD — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
REPATHA — Vascular occlusion
No rationale yet.
10/09/2026
CERUBIDINE — Pyrexia
No rationale yet.
10/09/2026
CERUBIDINE — Neutropenia
No rationale yet.
10/09/2026
VINCRISTINE SULFATE — Pyrexia
No rationale yet.
10/09/2026
VINCRISTINE SULFATE — Neutropenia
No rationale yet.
10/09/2026
ENHERTU — Interstitial lung disease
No rationale yet.
10/09/2026
ELIQUIS — Off label use
No rationale yet.
10/09/2026
ELIQUIS — Myasthenia gravis
No rationale yet.
10/09/2026
ZURZUVAE — Dizziness
No rationale yet.
10/09/2026
ZURZUVAE — Visual field defect
No rationale yet.
10/09/2026
ZURZUVAE — Feeling abnormal
No rationale yet.
10/09/2026
IMBRUVICA — Death
No rationale yet.
10/09/2026
VABYSMO — Reading disorder
No rationale yet.
10/09/2026
VABYSMO — Eye disorder
No rationale yet.
10/09/2026
VABYSMO — Visual impairment
No rationale yet.
10/09/2026
SEMAGLUTIDE — Wrong technique in product usage process
No rationale yet.
10/09/2026
SEMAGLUTIDE — Incorrect dose administered
No rationale yet.
10/09/2026
SEMAGLUTIDE — Weight fluctuation
No rationale yet.
10/09/2026
SEMAGLUTIDE — Pancreatic enlargement
No rationale yet.
10/09/2026
SEMAGLUTIDE — Abdominal pain upper
No rationale yet.
10/09/2026
SEMAGLUTIDE — Crohn^s disease
No rationale yet.
10/09/2026
SEMAGLUTIDE — Dehydration
No rationale yet.
10/09/2026
EPCORITAMAB — Cystitis haemorrhagic
No rationale yet.
10/09/2026
EPCORITAMAB — Malignant neoplasm progression
No rationale yet.
10/09/2026
ZOLACABTAGENE AUTOLEUCEL — Cystitis haemorrhagic
No rationale yet.
10/09/2026
ZOLACABTAGENE AUTOLEUCEL — Malignant neoplasm progression
No rationale yet.
10/09/2026
FIRSTPASS MINI RIGHT — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
VYEPTI — Pharyngeal paraesthesia
No rationale yet.
10/09/2026
VABYSMO — Therapeutic product effect decreased
No rationale yet.
10/09/2026
VABYSMO — Subretinal fluid
No rationale yet.
10/09/2026
VABYSMO — Detachment of retinal pigment epithelium
No rationale yet.
10/09/2026
RYSTIGGO — Seizure like phenomena
No rationale yet.
10/09/2026
OCREVUS ZUNOVO — Injection site discharge
No rationale yet.
10/09/2026
CIMZIA — Inappropriate schedule of product administration
No rationale yet.
10/09/2026
CIMZIA — Product storage issue
No rationale yet.
10/09/2026
CIMZIA — Cellulitis
No rationale yet.
10/09/2026
Dual Chamber Temporary Pacemaker — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
DYMIC — Inadequate Osseointegration
No rationale yet.
10/09/2026
Midas Rex¿ — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
Comfort — Hyperglycemia
No rationale yet.
10/09/2026
Inset Guard — Hemorrhage/Blood Loss/Bleeding
No rationale yet.
10/09/2026
SENSOR MMT-5120D2 INSTINCT 780 1PK OUS 2 — Hyperglycemia
No rationale yet.
10/09/2026
FAST-FIX 360 CURVED NDL DELIVERY SYS — Foreign Body In Patient
No rationale yet.
10/09/2026
HAMILTON-G5 — Hypoxia
No rationale yet.
10/09/2026
TRANSMITTER MMT-7841ZN GST5G US — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
FAST FIX FLX CRVD INSRTR BNDR CANN SET — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
FreeStyle Libre 2 — Loss of consciousness
No rationale yet.
10/09/2026
SENSOR MMT-7040D4 EN — Hyperglycemia
No rationale yet.
10/09/2026
Achieva 3.0T TX — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
ENT MR8 — Insufficient Information
No rationale yet.
10/09/2026
MiniMed 720G OUS BLE Connect 3.0 mgdl — Hyperglycemia
No rationale yet.
10/09/2026
SENSOR MMT-7040A GUARDIAN4 5PK US — Hyperglycemia
No rationale yet.
10/09/2026
NIM 4.0 CONSOLE — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
Pump MMT-8062 FLEX US MG — Hyperglycemia
No rationale yet.
10/09/2026
GENAC — Inadequate Osseointegration
No rationale yet.
10/09/2026
QUARTET — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
EVAC 70 XTRA COBLATOR II — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
Contact Detach — Hyperglycemia
No rationale yet.
10/09/2026
ASSURITY MRI — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
MiniMed 780G OUS System BLE Connect 3.0 mmol/L — Hypoglycemia
No rationale yet.
10/09/2026
AIA-360 — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
Maxcore — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
PowerPort ClearVUE Slim Implantable Port, ChronoFlex, 6F — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
HAMILTON-MR1 — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
Paradigm REAL-Time Insulin Infusion Pump MMT-722NAL — Hyperglycemia
No rationale yet.
10/09/2026
SENSOR MMT-7040C9 EN — Hypoglycemia
No rationale yet.
10/09/2026
EMGALITY — Headache
No rationale yet.
10/09/2026
MiniMed 740G OUS System BLE Connect 3.0 mg/dL — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
TRANSMITTER MMT-7841ZW GST5G OUS — Hypoglycemia
No rationale yet.
10/09/2026
ZYMFENTRA — Haemorrhoids
No rationale yet.
10/09/2026
METRX II — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
FST FIX FLX REV CRVD INSRTR BNDR CANN ST — Foreign Body In Patient
No rationale yet.
10/09/2026
Kit MMT-1896ES MM780G MG — Hyperglycemia
No rationale yet.
10/09/2026
EVAC 70 XTRA HP COBLATOR II — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
PUMP MMT-1880L MM770G BLE MG — Hyperglycemia
No rationale yet.
10/09/2026
MiniMed 780G US System BLE Connect 3.0 mg/dL — Hemorrhage/Blood Loss/Bleeding
No rationale yet.
10/09/2026
Quick Set — Hemorrhage/Blood Loss/Bleeding
No rationale yet.
10/09/2026
Pump 1886 780G OUS BLE Pump mg/dL — Hyperglycemia
No rationale yet.
10/09/2026
ASAHI SION — Foreign Body In Patient
No rationale yet.
10/09/2026
Fisher & Paykel Healthcare — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
EVIS LUCERA BRONCHOFIBERVIDEOSCOPE — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
4K CAMERA HEAD — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
FreeStyle Libre 2 Plus — Hyperglycemia
No rationale yet.
10/09/2026
FreeStyle Libre 2 — Insufficient Information
No rationale yet.
10/09/2026
FreeStyle Libre 2 Plus — Loss of consciousness
No rationale yet.
10/09/2026
JRNY II ISRT XLPE DD RT SZ 1-2 9MM — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
Ingenia 1.5T — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
Unknown NGP — Hyperglycemia
No rationale yet.
10/09/2026
Nucleus CI532 Cochlear Implant with Slim Modiolar Electrode — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
PRIMA — Inadequate Osseointegration
No rationale yet.
10/09/2026
FULL RADIUS BONECUTTER 5.5MM PLATINUM — Insufficient Information
No rationale yet.
10/09/2026
FULL RADIUS BONECUTTER 5.5MM PLATINUM — Foreign Body In Patient
No rationale yet.
10/09/2026
Spinning Spiros¿, Closed Male Luer — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
FreeStyle Libre 3 Plus — Insufficient Information
No rationale yet.
10/09/2026
FreeStyle Libre 3 Plus — Shaking/Tremors
No rationale yet.
10/09/2026
FreeStyle Libre 3 Plus — Skin Infection
No rationale yet.
10/09/2026
PUMP MMT-1884L MM780G BLE 3.0 mg/ml — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
Inset II — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
FreeStyle Libre 2 — Skin Inflammation/ Irritation
No rationale yet.
10/09/2026
FreeStyle Libre 2 — Skin Infection
No rationale yet.
10/09/2026
FreeStyle Libre 2 — Fever
No rationale yet.
10/09/2026
FreeStyle Libre 2 — Purulent Discharge
No rationale yet.
10/09/2026
HEALICOIL RG 4.75MM W2 MT BL/CB WH — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
Inset Guard — Hyperglycemia
No rationale yet.
10/09/2026
Midas Rex® — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
Dexcom G6 Continuous Glucose Monitoring System — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
Alaris System — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
EVIS LUCERA ELITE COLONOVIDEOSCOPE — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
INTERTAN 10S 10MM X 38CM 125D LEFT — Malunion of Bone
No rationale yet.
10/09/2026
INTERTAN 10S 10MM X 38CM 125D LEFT — Pain
No rationale yet.
10/09/2026
CENTURION Vision System, Accessory, Active Sentry Handpiece — Insufficient Information
No rationale yet.
10/09/2026
Inset 30 — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
MIDAS REX — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
OXINIUM FEM HD 12/14 28MM -3 — Joint Dislocation
No rationale yet.
10/09/2026
Medline A10 LAL / Alternating Pressure Mattress System — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
ZYMFENTRA — Haematochezia
No rationale yet.
10/09/2026
UNITY High Performance VFC Pack — Insufficient Information
No rationale yet.
10/09/2026
UNITY High Performance VFC Pack — Eye Infections
No rationale yet.
10/09/2026
UNITY TOTAL PLUS Posterior Procedure Pack — Insufficient Information
No rationale yet.
10/09/2026
UNITY TOTAL PLUS Posterior Procedure Pack — Eye Infections
No rationale yet.
10/09/2026
JOURNEY DCF AP FEM CUT BLK 7 — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
MIDAS REX LEGEND — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
ASKU — Inadequate Osseointegration
No rationale yet.
10/09/2026
Midas Rex MR8 — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
Albuterol Sulfate Inhalation Aerosol — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
EVIS EXERA III COLONOVIDEOSCOPE — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
Inset Guard — Skin Inflammation/ Irritation
No rationale yet.
10/09/2026
Inset — Hyperglycemia
No rationale yet.
10/09/2026
FITRIGHT — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
OTHER ACCESSORIES — Hyperglycemia
No rationale yet.
10/09/2026
UNITY Light Probe — Insufficient Information
No rationale yet.
10/09/2026
UNITY Light Probe — Eye Infections
No rationale yet.
10/09/2026
SCR BIORCI-HA 7X25 7MM HEAD STERILE — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
Inset — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
ENT MR8 — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
iLet Bionic Pancreas — Concussion
No rationale yet.
10/09/2026
iLet Bionic Pancreas — Laceration(s)
No rationale yet.
10/09/2026
COLONOVIDEOSCOPE — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
INTERTAN 7.0MM COMP SCREW STARTER DRILL — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
PSS UNKNOWN TOOL — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
EDWARDS SAPIEN 3 TRANSCATHETER — Insufficient Information
No rationale yet.
10/09/2026
Supra Air Mattresses — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
AIMER ENDOFEMORAL 7MM OFFSET (GOLD) — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
MiniMed 780G US System BLE Connect 3.0 mg/dL — Hypoglycemia
No rationale yet.
10/09/2026
MiniMed 780G OUS System BLE Connect 3.0 mmol/L — Hyperglycemia
No rationale yet.
10/09/2026
HEALICOIL KNOTLESS PK NST — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
POLARSTEM MODULAR HEAD FOR 21000662 — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
Comfort — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
FreeStyle Libre 14 Day — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
HAMILTON-C6 — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
FreeStyle Libre 3 — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
iLet Bionic Pancreas — Confusion/ Disorientation
No rationale yet.
10/09/2026
iLet Bionic Pancreas — Muscle Weakness/Atrophy
No rationale yet.
10/09/2026
AIMER ENDOFEMORAL 6MM OFFSET (GREEN) — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
TENDRIL STS — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
TENDRIL STS — Dizziness
No rationale yet.
10/09/2026
TENDRIL STS — Arrhythmia
No rationale yet.
10/09/2026
GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
MIDAS REX MR8 — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
MiniMed 780G US System BLE Connect 3.0 mg/dL — Hyperglycemia
No rationale yet.
10/09/2026
FreeStyle Libre 3 Plus — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
FreeStyle Libre 2 Plus — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
Bipap A40 Pro — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
ASSURITY MRI — Dizziness
No rationale yet.
10/09/2026
ASSURITY MRI — Arrhythmia
No rationale yet.
10/09/2026
FAST-FIX 360 CURVED NDL DELIVERY SYS — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
Dexcom G7 15 Day Continuous Glucose Monitoring System — Hyperglycemia
No rationale yet.
10/09/2026
FUJIFILM Endoscopic CO2 Regulator GW-100 — Hearing Impairment
No rationale yet.
10/09/2026
F&P Evaqua — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
Inset II — Hyperglycemia
No rationale yet.
10/09/2026
Dexcom G7 Continuous Glucose Monitoring System — Hyperglycemia
No rationale yet.
10/09/2026
MYNX CONTROL — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
StealthStation¿ S8 system — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
t:slim X2 Insulin Pump with Control-IQ+ Technology — Hypoglycemia
No rationale yet.
10/09/2026
t:slim X2 Insulin Pump with Control-IQ Technology — Elevated Ketones/ Diabetic Ketoacidosis
No rationale yet.
10/09/2026
t:slim X2 Insulin Pump with Control-IQ Technology — Hyperglycemia
No rationale yet.
10/09/2026
Allure RF — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
iLet Bionic Pancreas — Loss of consciousness
No rationale yet.
10/09/2026
iLet Bionic Pancreas — Hypoglycemia
No rationale yet.
10/09/2026
iLet Bionic Pancreas — Bone Fracture(s)
No rationale yet.
10/09/2026
TENDRIL ST — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
MYNXGRIP — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
EverFlo — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
t:slim X2 Insulin Pump with Control-IQ+ Technology — Elevated Ketones/ Diabetic Ketoacidosis
No rationale yet.
10/09/2026
t:slim X2 Insulin Pump with Control-IQ+ Technology — Hyperglycemia
No rationale yet.
10/09/2026
EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
Trilogy Evo, Japan — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
Trilogy100 Ventilator, Japan-Rental — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
Trilogy — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
GORE® EXCLUDER® Iliac Branch Endoprosthesis — Thrombosis/Thrombus
No rationale yet.
10/09/2026
Quick Set — Hyperglycemia
No rationale yet.
10/09/2026
Quick Set — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
Inset Guard — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
Evoke Closed Loop Stimulator (CLS) (US) — Inadequate Pain Relief
No rationale yet.
10/09/2026
GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis — Thrombosis/Thrombus
No rationale yet.
10/09/2026
Quadra Allure MP RF CRT-P — Insufficient Information
No rationale yet.
10/09/2026
EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
InterStim X — Electric Shock
No rationale yet.
10/09/2026
InterStim X — Pain
No rationale yet.
10/09/2026
Tandem Mobi Insulin Pump with Control-IQ+ Technology — Hyperglycemia
No rationale yet.
10/09/2026
Dexcom G7 Continuous Glucose Monitoring System — Hypoglycemia
No rationale yet.
10/09/2026
GORE® DrySeal Flex Introducer Sheath — Vascular Dissection
No rationale yet.
10/09/2026
MiniMed 780G US System BLE Connect 3.0 mg/dL — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
FreeStyle Libre 2 — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
VEOZAH — Pain in extremity
No rationale yet.
10/09/2026
CISPLATIN — Ear pain
No rationale yet.
10/09/2026
CISPLATIN — Neck pain
No rationale yet.
10/09/2026
CISPLATIN — Nasal obstruction
No rationale yet.
10/09/2026
CISPLATIN — Dry mouth
No rationale yet.
10/09/2026
CISPLATIN — Headache
No rationale yet.
10/09/2026
CISPLATIN — Hypoproteinaemia
No rationale yet.
10/09/2026
CISPLATIN — Decreased appetite
No rationale yet.
10/09/2026
CISPLATIN — Asthenia
No rationale yet.
10/09/2026
ABRAXANE — Ear pain
No rationale yet.
10/09/2026
ABRAXANE — Neck pain
No rationale yet.
10/09/2026
ABRAXANE — Nasal obstruction
No rationale yet.
10/09/2026
ABRAXANE — Dry mouth
No rationale yet.
10/09/2026
ABRAXANE — Headache
No rationale yet.
10/09/2026
ABRAXANE — Hypoproteinaemia
No rationale yet.
10/09/2026
ABRAXANE — Decreased appetite
No rationale yet.
10/09/2026
ABRAXANE — Asthenia
No rationale yet.
10/09/2026
TISLELIZUMAB — Ear pain
No rationale yet.
10/09/2026
TISLELIZUMAB — Neck pain
No rationale yet.
10/09/2026
TISLELIZUMAB — Nasal obstruction
No rationale yet.
10/09/2026
TISLELIZUMAB — Dry mouth
No rationale yet.
10/09/2026
TISLELIZUMAB — Headache
No rationale yet.
10/09/2026
TISLELIZUMAB — Hypoproteinaemia
No rationale yet.
10/09/2026
TISLELIZUMAB — Decreased appetite
No rationale yet.
10/09/2026
TISLELIZUMAB — Asthenia
No rationale yet.
10/09/2026
CIMZIA — Off label use
No rationale yet.
10/09/2026
CIMZIA — Subcutaneous abscess
No rationale yet.
10/09/2026
LANTUS — Contraindicated product administered
No rationale yet.
10/09/2026
SOLIQUA 100/33 — Contraindicated product administered
No rationale yet.
10/09/2026
SOLIQUA 100/33 — Off label use
No rationale yet.
10/09/2026
Omnipod 5 Pods — Hyperglycemia
No rationale yet.
10/09/2026
Dexcom G7 Continuous Glucose Monitoring System — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
STRATAFIX Symmetric PDS Plus — Hernia
No rationale yet.
10/09/2026
STRATAFIX Symmetric PDS Plus — Vomiting
No rationale yet.
10/09/2026
STRATAFIX Symmetric PDS Plus — Wound Dehiscence
No rationale yet.
10/09/2026
Vanta — No Clinical Signs, Symptoms or Conditions
No rationale yet.
10/09/2026
RENFLEXIS — Weight increased
No rationale yet.
10/09/2026
DUPIXENT — Yellow skin
No rationale yet.
10/09/2026
LANTUS — Off label use
No rationale yet.
10/09/2026
LANTUS — Blood glucose increased
No rationale yet.
10/09/2026
DUPIXENT — Hypersensitivity
No rationale yet.
10/09/2026
DUPIXENT — Nasopharyngitis
No rationale yet.
10/09/2026
DUPIXENT — Nasal congestion
No rationale yet.
10/09/2026
LANTUS — Product administered at inappropriate site
No rationale yet.
10/09/2026
LANTUS — Cold sweat
No rationale yet.
10/09/2026
LANTUS — Feeling hot
No rationale yet.
10/09/2026
LANTUS — Blood glucose decreased
No rationale yet.
10/09/2026
TRAMADOL — Abdominal discomfort
No rationale yet.
10/09/2026
TRAMADOL — Shoulder operation
No rationale yet.
10/09/2026
XYWAV — Abdominal discomfort
No rationale yet.
10/09/2026
XYWAV — Shoulder operation
No rationale yet.
10/09/2026
DUPIXENT — Glycosylated haemoglobin increased
No rationale yet.
10/09/2026
DAPAGLIFLOZIN — Candida infection
No rationale yet.
10/09/2026
OXALIPLATIN — Product use in unapproved indication
No rationale yet.
10/09/2026
OXALIPLATIN — Venoocclusive liver disease
No rationale yet.
10/09/2026
OXALIPLATIN — Non-cirrhotic portal hypertension
No rationale yet.
10/09/2026
OXALIPLATIN — Portal vein dilatation
No rationale yet.
10/09/2026
OXALIPLATIN — Stomal varices
No rationale yet.
10/09/2026
DUPIXENT — Aphonia
No rationale yet.
10/09/2026
DUPIXENT — Influenza
No rationale yet.
10/09/2026
NOVOLOG — Nausea
No rationale yet.
10/09/2026
NOVOLOG — Fatigue
No rationale yet.
10/09/2026
DUPIXENT — Product preparation issue
No rationale yet.
10/09/2026
DUPIXENT — Myalgia
No rationale yet.
10/09/2026
DUPIXENT — Neuralgia
No rationale yet.
10/09/2026
DUPIXENT — Contusion
No rationale yet.
10/09/2026
DUPIXENT — Dyspnoea
No rationale yet.
10/09/2026
DUPIXENT — Fatigue
No rationale yet.
10/09/2026
DUPIXENT — Product use in unapproved indication
No rationale yet.
10/09/2026
DUPIXENT — Eosinophilic oesophagitis
No rationale yet.
10/09/2026
PREGABALIN — Medication error
No rationale yet.
10/09/2026
PREGABALIN — Akathisia
No rationale yet.
10/09/2026
DUPIXENT — Condition aggravated
No rationale yet.
10/09/2026
DUPIXENT — Eczema
No rationale yet.
10/09/2026
DUPIXENT — Skin ulcer
No rationale yet.
10/09/2026
DUPIXENT — Skin swelling
No rationale yet.
10/09/2026
OZEMPIC — Dental caries
No rationale yet.
10/09/2026
NOVOLOG — Dizziness
No rationale yet.
10/09/2026
LANTUS — Device issue
No rationale yet.
10/09/2026
LANTUS — Injection site pain
No rationale yet.
10/09/2026
DUPIXENT — Burning sensation
No rationale yet.
10/09/2026
DUPIXENT — Dermatitis atopic
No rationale yet.
10/09/2026
DUPIXENT — Insomnia
No rationale yet.
10/09/2026
DUPIXENT — Rhinorrhoea
No rationale yet.
10/09/2026
DUPIXENT — Drug hypersensitivity
No rationale yet.
10/09/2026
DUPIXENT — Incorrect dose administered
No rationale yet.
10/09/2026
DUPIXENT — Eye irritation
No rationale yet.
10/09/2026
DUPIXENT — Dry eye
No rationale yet.
10/09/2026
DUPIXENT — Oral mucosal blistering
No rationale yet.
10/09/2026
DUPIXENT — Oral disorder
No rationale yet.
10/09/2026
DUPIXENT — Poor quality product administered
No rationale yet.
10/09/2026
DUPIXENT — Body tinea
No rationale yet.
10/09/2026
TREMFYA — Product dose omission issue
No rationale yet.
10/09/2026
TREMFYA — Product leakage
No rationale yet.
10/09/2026
TREMFYA — Device issue
No rationale yet.
10/09/2026
NOVOLOG — Throat tightness
No rationale yet.
10/09/2026
NOVOLOG — Blood pressure increased
No rationale yet.
10/09/2026
NOVOLOG — Dyspraxia
No rationale yet.
10/09/2026
NOVOLOG — Hyperhidrosis
No rationale yet.
10/09/2026
NOVOLOG — Tachypnoea
No rationale yet.
10/09/2026
OTEZLA — Musculoskeletal stiffness
No rationale yet.
10/09/2026
CARBOPLATIN — Myelosuppression
No rationale yet.
10/09/2026
DOCETAXEL — Myelosuppression
No rationale yet.
10/09/2026
ONTRUZANT — Myelosuppression
No rationale yet.
10/09/2026
ICOTYDE — Nausea
No rationale yet.
10/09/2026
ICOTYDE — Diarrhoea
No rationale yet.
10/09/2026
TREMFYA — Drug ineffective
No rationale yet.
10/09/2026
KEYTRUDA — Immune-mediated adverse reaction
No rationale yet.
10/09/2026
KEYTRUDA — Liver disorder
No rationale yet.
10/09/2026
PADCEV EJFV — Immune-mediated adverse reaction
No rationale yet.
10/09/2026
PADCEV EJFV — Liver disorder
No rationale yet.
10/09/2026
CAMZYOS — Incontinence
No rationale yet.
10/09/2026
CAMZYOS — Back pain
No rationale yet.
10/09/2026
CAMZYOS — Urinary tract infection
No rationale yet.
10/09/2026
EMPAVELI — Off label use
No rationale yet.
10/09/2026
EMPAVELI — Endophthalmitis
No rationale yet.
10/09/2026
EMPAVELI — Blindness
No rationale yet.
10/09/2026
RELEUKO — Drug ineffective
No rationale yet.
10/09/2026
RELEUKO — Product use in unapproved indication
No rationale yet.
10/09/2026
RELEUKO — Cytopenia
No rationale yet.
10/09/2026
CYCLOPHOSPHAMIDE — Drug ineffective
No rationale yet.
10/09/2026
CYCLOPHOSPHAMIDE — Product use in unapproved indication
No rationale yet.
10/09/2026
CYCLOPHOSPHAMIDE — Cytopenia
No rationale yet.
10/09/2026
INSULIN ASPART\INSULIN DEGLUDEC — Anxiety
No rationale yet.
10/09/2026
INSULIN ASPART\INSULIN DEGLUDEC — Fracture
No rationale yet.
10/09/2026
OFEV — Death
No rationale yet.
10/09/2026
TEZEPELUMAB — Pneumonia
No rationale yet.
10/09/2026
ZYMFENTRA — Underdose
No rationale yet.
10/09/2026
ZYMFENTRA — Fistula
No rationale yet.
10/09/2026
ZYMFENTRA — Weight increased
No rationale yet.
10/09/2026
ZYMFENTRA — Harvey-Bradshaw index increased
No rationale yet.
10/09/2026
AZACITIDINE — Myelosuppression
No rationale yet.
10/09/2026
AZACITIDINE — Granulocyte count decreased
No rationale yet.
10/09/2026
AZACITIDINE — Neutrophil count decreased
No rationale yet.
10/09/2026
AZACITIDINE — Anaemia
No rationale yet.
10/09/2026
AZACITIDINE — Platelet count decreased
No rationale yet.
10/09/2026
AZACITIDINE — Oral infection
No rationale yet.
10/09/2026
AZACITIDINE — Pneumonia bacterial
No rationale yet.
10/09/2026
AZACITIDINE — White blood cell count decreased
No rationale yet.
10/09/2026
VENCLEXTA — Myelosuppression
No rationale yet.
10/09/2026
VENCLEXTA — Granulocyte count decreased
No rationale yet.
10/09/2026
VENCLEXTA — Neutrophil count decreased
No rationale yet.
10/09/2026
VENCLEXTA — Anaemia
No rationale yet.
10/09/2026
VENCLEXTA — Platelet count decreased
No rationale yet.
10/09/2026
VENCLEXTA — Oral infection
No rationale yet.
10/09/2026
VENCLEXTA — Pneumonia bacterial
No rationale yet.
10/09/2026
VENCLEXTA — White blood cell count decreased
No rationale yet.
10/09/2026
PROLIA — Skin disorder
No rationale yet.
10/09/2026
OZEMPIC — Product use in unapproved indication
No rationale yet.
10/09/2026
OZEMPIC — Ill-defined disorder
No rationale yet.
10/09/2026
OZEMPIC — Neoplasm malignant
No rationale yet.
10/09/2026
OZEMPIC — Asthma
No rationale yet.
10/09/2026
OZEMPIC — Disability
No rationale yet.
10/09/2026
LINZESS — Drug ineffective
No rationale yet.
10/09/2026
LINZESS — Disability
No rationale yet.
10/09/2026
TAGRISSO — Product use issue
No rationale yet.
10/09/2026
TAGRISSO — Wrong technique in product usage process
No rationale yet.
10/09/2026
TAGRISSO — Intentional product use issue
No rationale yet.
10/09/2026
TAGRISSO — Renal impairment
No rationale yet.
10/09/2026
TAGRISSO — Cardiac dysfunction
No rationale yet.
10/09/2026
STRENSIQ — Malaise
No rationale yet.
10/09/2026
STRENSIQ — Pyrexia
No rationale yet.
10/09/2026
SKYRIZI — Ovarian cyst
No rationale yet.
10/09/2026
SKYRIZI — Drug ineffective
No rationale yet.
10/09/2026
SKYRIZI — Radiotherapy
No rationale yet.
10/09/2026
SKYRIZI — Breast operation
No rationale yet.
10/09/2026
HUMIRA — Complex regional pain syndrome
No rationale yet.
10/09/2026
HUMIRA — Hernia
No rationale yet.
10/09/2026
HUMIRA — Intervertebral disc protrusion
No rationale yet.
10/09/2026
HUMIRA — Cervical vertebral fracture
No rationale yet.
10/09/2026
HUMIRA — Fall
No rationale yet.
10/09/2026
HUMIRA — Exostosis
No rationale yet.
10/09/2026
HUMIRA — Nerve compression
No rationale yet.
10/09/2026
HUMIRA — Muscle atrophy
No rationale yet.
10/09/2026
HUMIRA — Nerve injury
No rationale yet.
10/09/2026
HUMIRA — Carpal tunnel decompression
No rationale yet.
10/09/2026
HUMIRA — Drug ineffective
No rationale yet.
10/09/2026
HUMIRA — Spinal fracture
No rationale yet.
10/09/2026
PREDNISONE — Septic shock
No rationale yet.
10/09/2026
PREDNISONE — Thrombocytopenia
No rationale yet.
10/09/2026
PREDNISONE — Leukopenia
No rationale yet.
10/09/2026
AGRYLIN — Weight decreased
No rationale yet.
10/09/2026
DEXAMETHASONE — Strongyloidiasis
No rationale yet.
10/09/2026
DEXAMETHASONE — Pulmonary alveolar haemorrhage
No rationale yet.
10/09/2026
DEXAMETHASONE — Respiratory failure
No rationale yet.
10/09/2026
ZEPBOUND — Diarrhoea
No rationale yet.
10/09/2026
ZEPBOUND — Vomiting
No rationale yet.
10/09/2026
ZEPBOUND — Malaise
No rationale yet.
10/09/2026
ZEPBOUND — Sneezing
No rationale yet.
10/09/2026
ZEPBOUND — Cough
No rationale yet.
10/09/2026
ZEPBOUND — Oropharyngeal pain
No rationale yet.
10/09/2026
ZEPBOUND — Respiratory disorder
No rationale yet.
10/09/2026
VERZENIO — Diarrhoea
No rationale yet.
10/09/2026
ZEPBOUND — Migraine
No rationale yet.
10/09/2026
EBGLYSS — Maternal exposure during pregnancy
No rationale yet.
10/09/2026
WEGOVY — Product use in unapproved indication
No rationale yet.
10/09/2026
WEGOVY — Miosis
No rationale yet.
10/09/2026
HEMLIBRA — Skin laceration
No rationale yet.
10/09/2026
HEMLIBRA — Head injury
No rationale yet.
10/09/2026
TRINTELLIX — No adverse event
No rationale yet.
10/09/2026
TRINTELLIX — Product use issue
No rationale yet.
10/09/2026
HEMLIBRA — Haemorrhage
No rationale yet.
10/09/2026
RINVOQ — Peripheral swelling
No rationale yet.
10/09/2026
RINVOQ — Hepatic enzyme increased
No rationale yet.
10/09/2026
RINVOQ — Creatine kinase increased
No rationale yet.
10/09/2026
RINVOQ — Pain in extremity
No rationale yet.
10/09/2026
RINVOQ — Blood potassium increased
No rationale yet.
10/09/2026
VENTOLIN HFA — Wrong technique in device usage process
No rationale yet.
10/09/2026
VENTOLIN HFA — Cough
No rationale yet.
10/09/2026
VENTOLIN HFA — Sputum abnormal
No rationale yet.
10/09/2026
VENTOLIN HFA — Dysgeusia
No rationale yet.
10/09/2026
STRENSIQ — Dry eye
No rationale yet.
10/09/2026
STRENSIQ — Fibromyalgia
No rationale yet.
10/09/2026
STRENSIQ — Dry mouth
No rationale yet.
10/09/2026
STRENSIQ — Greater trochanteric pain syndrome
No rationale yet.
10/09/2026
STRENSIQ — Road traffic accident
No rationale yet.
10/09/2026
STRENSIQ — Thrombotic thrombocytopenic purpura
No rationale yet.
10/09/2026
STRENSIQ — Sternal fracture
No rationale yet.
10/09/2026
Combination Therapy (Mirdametinib and Sirolimus) for RAS Mutated Relapsed Refractory Multiple Myeloma — Trial safety note
No rationale yet.
10/09/2026
Pharmacokinetics of GH001 Delivered Via a Proprietary Aerosol Delivery Device in Healthy Subjects — Trial safety note
No rationale yet.
10/09/2026
Efficacy and Safety of Delgocitinib and Its Impact on Patient's Perspective for Moderate-to-severe Chronic Hand Eczema in Adults: A 16-week — Study lead
No rationale yet.
10/09/2026
Extraction-string ureteral stents and postoperative infection after flexible ureteroscopy: an IPTW-adjusted analysis. — Study lead
No rationale yet.
10/09/2026
Comparative safety of imeglimin versus sitagliptin in Japanese patients with type 2 diabetes: A pharmacy-based retrospective cohort study. — Study lead
No rationale yet.
10/09/2026
Using dapagliflozin to reduce symptoms in transthyretin cardiac amyloidosis: An n-of-1 trial series pilot study. — Study lead
No rationale yet.
10/09/2026
Burden and determinants of hyperglycaemia and dyslipidaemia in Zimbabwean adults living with HIV on dolutegravir-based first-line antiretrov — Study lead
No rationale yet.
10/09/2026
The dipeptidyl peptidase 1 inhibition landscape in bronchiectasis and its future direction. — Study lead
No rationale yet.
10/09/2026
Short-term prophylactic biliary stenting after complete common bile duct stone removal to prevent post-ERCP cholangitis in Japan (STEP-ERCP — Study lead
No rationale yet.
10/09/2026
Emerging risks of health optimisation: refractory nausea associated with peptide injections reported to contain retatrutide. — Study lead
No rationale yet.
10/09/2026
Targeting CD6 in solid tumors: safety, early efficacy, and mechanistic insights from a proof-of-concept trial of itolizumab. — Study lead
No rationale yet.
10/09/2026
Short- versus long-course antibiotic therapy in non-severe CAP in children: a systematic review and meta-analysis. — Study lead
No rationale yet.
10/09/2026
Efficacy and safety of endovascular coiling compared to microsurgical clipping in aneurysmal subarachnoid hemorrhage: a systematic review an — Study lead
No rationale yet.
10/09/2026
Machine learning models for prediction of continuous positive airway pressure failure and high-flow nasal cannula failure in preterm neonate — Study lead
No rationale yet.
10/09/2026
Feasibility of clinical implementation and acceptability of patient-reported screening for chemotherapy-induced peripheral neuropathy (CIPN) — Study lead
No rationale yet.
10/09/2026
Efficacy and safety of PCSK9 inhibitors combined with statins in acute ischemic stroke: a systematic review and meta-analysis. — Study lead
No rationale yet.
10/09/2026
Skin and Brain in Bipolar Disorder: A Review of Dermatologic-Psychotropic Drug Interactions. — Study lead
No rationale yet.
10/09/2026
Patient experiences of benzodiazepine tapering: a qualitative study of treatment in addiction care. — Study lead
No rationale yet.
10/09/2026
Stratifying Cardiovascular Risk in Patients With HCC Receiving Atezolizumab/Bevacizumab: A Comparison of ESC and CARDIOSOR Scores. — Study lead
No rationale yet.
10/09/2026
Femoral Nerve Palsy as a Complication of Pavlik Harness Treatment for Developmental Dysplasia of the Hip: Ten-Year Prospective Study. — Study lead
No rationale yet.
10/09/2026
Investigating Potential Adverse Drug Reactions of Lisdexamfetamine Using Sequence Symmetry Analysis. — Study lead
No rationale yet.
10/09/2026
Diagnosis and Management of Nitazene Dependence in Sydney, Australia: A Case Series. — Study lead
No rationale yet.
10/09/2026
ROZLYTREK — Labeling change
No rationale yet.
10/09/2026
PONLIMSI — Labeling change
No rationale yet.
10/09/2026
PIFELTRO — Labeling change
No rationale yet.
10/09/2026
OLUMIANT — Labeling change
No rationale yet.
10/09/2026
JAYPIRCA — Labeling change
No rationale yet.
10/09/2026
GAZYVA — Labeling change
No rationale yet.
10/09/2026
EYDENZELT — Labeling change
No rationale yet.
10/09/2026
DELSTRIGO — Labeling change
No rationale yet.
10/09/2026
CAMZYOS — Labeling change
No rationale yet.
10/09/2026
AVTOZMA — Labeling change
No rationale yet.
10/09/2026
ARGATROBAN IN SODIUM CHLORIDE — Labeling change
No rationale yet.
10/09/2026
ABG I ACETABULAR INSERT HOODED 28mm ID X 48mm C-M079-2-801 ARC2F ACETABULAR INSERT 48/50/52mm OD x 28mm ID — Recall or enforcement action
No rationale yet.
10/09/2026
Captus 4000e Thyroid Uptake System, Models: 1. 5430-30151, 2. 5430-30152, 3. 5430-30154; — Recall or enforcement action
No rationale yet.
10/09/2026
Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL Applicator. Kit Model Number: — Recall or enforcement action
No rationale yet.
10/09/2026
New York Embroidery Studio Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large. Model Number: NYES100-2. — Recall or enforcement action
No rationale yet.
10/09/2026
REF:B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 5X75MM — Recall or enforcement action
No rationale yet.
10/09/2026
REF: HF2POSTD HomeFill Oxygen System HomeFill cylinder D with CGA870 Compatible Post Valve — Recall or enforcement action
No rationale yet.
10/09/2026
Brand Name: Heidelberg Engineering GmbH Product Name: SPECTRALIS with Flex Module Model/Catalog Number: S3610, S2610, — Recall or enforcement action
No rationale yet.
10/09/2026
Reign Medical Clench Staple System (Compression), Description/REF: 9mm x 7mm/152-30907; 11mm x 10mm/152-31110; 15mm — Recall or enforcement action
No rationale yet.
10/09/2026
Medline Convenience Kits: 1) ANTERIOR SPINE PACK, Catalog Number: DYNJT10197; 2) CRANIOTOMY #IMF 56646-LF, Catalog Nu — Recall or enforcement action
No rationale yet.
10/09/2026
SCORPIO C-DOME PATELLA 73-2710 73-2910 SCORPIO U-DOME PATELLA 73-3110 73-3508 73-3708 73-3710 73-391 — Recall or enforcement action
No rationale yet.
10/09/2026
Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Number: BD-420X-1355. — Recall or enforcement action
No rationale yet.
10/09/2026
Ingenia 1.5T, Ingenia 1.5T CX and Ingenia 1.5T S; Model Numbers (REF): 1. 781315(1.5T), 2. 781341(1.5T), 3. 781396(1.5T — Recall or enforcement action
No rationale yet.
10/09/2026
Medline Convenience Kits: 1) KIT ANESTHESIA L&D A- LINE SET, Catalog Number: DYKMBNDL199A — Recall or enforcement action
No rationale yet.
10/09/2026
Olympus BiCOAG Hemostasis Probe 10Fr Coaxial Connector. Model/Catalog Number: CD-B610LA. — Recall or enforcement action
No rationale yet.
10/09/2026
Philips PIC iX Essentials REF:867093 — Recall or enforcement action
No rationale yet.
10/09/2026
IV Sets with drip chambers — Recall or enforcement action
No rationale yet.
10/09/2026
Plum administration sets — Recall or enforcement action
No rationale yet.
10/09/2026
StatStrip Glucose Hospital Meter System. Model No: 63685. Glucose test system. — Recall or enforcement action
No rationale yet.
10/09/2026
StatStrip Glucose and B- Ketone meter. Model No: 63683. Glucose test system. — Recall or enforcement action
No rationale yet.
10/09/2026
Cardioroot Woven Collagen Coated Vascular Graft; Model Numbers: 1. HEWROOT0024, 2. HEWROOT0026, 3. HEWROOT0028, 4. HEWR — Recall or enforcement action
No rationale yet.
10/09/2026
Haylard UNIV IMAGING BIOPSY TRUCUSTOM; Model/Item Number (Kit): VARV042-03; — Recall or enforcement action
No rationale yet.
10/09/2026
Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Contr — Recall or enforcement action
No rationale yet.
10/09/2026
MR 5300 Model Number (REF): 1. 782110, 2. 782152; — Recall or enforcement action
No rationale yet.
10/09/2026
Centricity PACS Server V7, intended for managing digital medical images and associated data, All versions — Recall or enforcement action
No rationale yet.
10/09/2026
Happiest Baby, Inc SNOO Sleep Sack, X-Small Model/Catalog Number: S2101-101 S2101-108-6 S2101-133 S2102-112 S2107-101 — Recall or enforcement action
No rationale yet.
10/09/2026
MR 7700 and Upgrade to MR 7700; Model Number (REF): 1. 782120, 2. 782153, 3. 782130 (Upgrade); — Recall or enforcement action
No rationale yet.
10/09/2026
VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811 — Recall or enforcement action
No rationale yet.
10/09/2026
Medline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008N — Recall or enforcement action
No rationale yet.
10/09/2026
Oncology sets with drip chambers — Recall or enforcement action
No rationale yet.
10/09/2026
Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, tempe — Recall or enforcement action
No rationale yet.
10/09/2026
nGenuity Patient Monitor with Capnography (ETCO2) CAT 8100E1-ST-US, CAT 8100E1-US, CAT 8100EP1, CAT 8100EP1-ST, CAT 8 — Recall or enforcement action
No rationale yet.
10/09/2026
Aisys CS2, Datex-Ohmeda anesthesia system, Part Number 1011-9055-000 — Recall or enforcement action
No rationale yet.
10/09/2026
Ingenia Elition S and Ingenia Elition X; Model Numbers (REF): 1. 781357(S), 2. 782106(S), 3. 782137(S), 4. 781358(X), 5 — Recall or enforcement action
No rationale yet.
10/09/2026
StatStrip Glucose and B- Ketone meter. Model No: 63910. Glucose test system. — Recall or enforcement action
No rationale yet.
10/09/2026
CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors; Model Number: 03-2522-1; — Recall or enforcement action
No rationale yet.
10/09/2026
Carescape Central Station CSCS V3 MAS800 Desktop Part Number 5867474-04, 5867474-13 Product code STU CSCS V3 MAI — Recall or enforcement action
No rationale yet.
10/09/2026
Medline Convenience Kits: 1) DYKM1000B, Catalog Number: DYKM1000B; 2) DYKM2187A, Catalog Number: DYKM2187A — Recall or enforcement action
No rationale yet.
10/09/2026
INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set. Stay-Flex tubing component. 5 units per box. Mod — Recall or enforcement action
No rationale yet.
10/09/2026
Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella C — Recall or enforcement action
No rationale yet.
10/09/2026
Achieva 3.0T; Model Numbers (REF): 1. 781177, 2. 781277, 3. 781278, 4. 781344, 5. 781345; — Recall or enforcement action
No rationale yet.
10/09/2026
Medline convenience kits containing Healthmark Instrument Channel Brushes. SINUS PACK DYNJ48258D and Sinus Pack DYNJ4825 — Recall or enforcement action
No rationale yet.
10/09/2026
Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector. Model/Catalog Number: CD-B622LA. — Recall or enforcement action
No rationale yet.
10/09/2026
Haylard 18G SINGLE SHOT EPI TRAY; Model/Item Number (Kit): DPGE002-02; — Recall or enforcement action
No rationale yet.
10/09/2026
Et Control, Software option for anesthesia gas machine to achieve and maintain targeted end tidal oxygen and anesthetic — Recall or enforcement action
No rationale yet.
10/09/2026
Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000-000 — Recall or enforcement action
No rationale yet.
10/09/2026
REF:2B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 75MM — Recall or enforcement action
No rationale yet.
10/09/2026
MENOW SUNSCREEN PRESSED POWDER SPF35 PA+++, Net content, 9g/0.32 oz, Manufactured by: Shantzu Qiwei Industry Co. Ltd, A — Recall or enforcement action
No rationale yet.
10/09/2026
Reliable-1 Laboratories Lubricating Tears, Sterile, 0.5 FL OZ (15 mL) bottles, Distributed by: Reliable-1 Laboratories L — Recall or enforcement action
No rationale yet.
10/09/2026
Dopamine HCl Inj., USP, 200 mg/5 mL (40 mg/mL), 5 mL Single-dose, 25 vials per tray, Rx only, Distributed by Hospira, In — Recall or enforcement action
No rationale yet.
10/09/2026
Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye Drops (glycerin 0.25%, naphazoline hydrochloride 0.012%) , 0.5 — Recall or enforcement action
No rationale yet.
10/09/2026
Walgreens Lubricant Eye Drops, Carboxymethylcellulose sodium 0.5%, Lubricant Eye Drops, Sterile, 0.5 OZ (15 mL) bottles, — Recall or enforcement action
No rationale yet.
10/09/2026
Major LubriFresh P.M. Nighttime Ointment, Net wt. 0.125 oz. (3.5 g) tubes, Distributed by: Major Pharmaceuticals, 17177 — Recall or enforcement action
No rationale yet.
10/09/2026
Nystatin Cream, USP, 15 g per tube, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761; Di — Recall or enforcement action
No rationale yet.
10/09/2026
Olanzapine Tablets, USP 5 mg, 30-count bottle, Rx Only, Manufactured For: Macleods Pharma USA, Inc. Princeton, NJ, 08540 — Recall or enforcement action
No rationale yet.
10/09/2026
0.9% Sodium Chloride Injection, 100 mL, USP, ICU Medical, Inc., Lake Forest, Illinois 60045, USA, NDC 0990-7984-23. — Recall or enforcement action
No rationale yet.
10/09/2026
Chlorthalidone Tablets, USP, 25 mg, 100 Tablets per bottle, Rx only, Manufactured by: Inventia Healthcare Limited. NDC — Recall or enforcement action
No rationale yet.
10/09/2026
Lidocaine Ointment USP, 5%, Speermint Flavor, 50 g Jar, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, — Recall or enforcement action
No rationale yet.
10/09/2026
Fluphenazine HCl Elixir, USP, 2.5 mg per 5 mL, Delivers: 5 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Onl — Recall or enforcement action
No rationale yet.
10/09/2026
Fluphenazine HCl Elixir, USP, 5 mg per 1 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only — Recall or enforcement action
No rationale yet.
10/09/2026
Exenatide Injection, USP, 250 mcg/mL, 1.2 mL per prefilled pen, Rx Only, Subcutaneous Use Only, For Single Patient Use O — Recall or enforcement action
No rationale yet.
10/09/2026
Walgreens Lubricant Eye Drops, 0.5 FL OZ (15 mL) 1.0 FL OZ (30 mL) TOTAL, 2 count Twin Pack, Distributed by Walgreens Co — Recall or enforcement action
No rationale yet.
10/09/2026
Fluphenazine HCl Elixir, USP, 5 mg per 10 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Onl — Recall or enforcement action
No rationale yet.
10/09/2026
Thyroid Tablets, USP, 1/2 Grain (30 mg), Each tablet contains: levothyroxine (T4) 19 mcg, liothyronine (T3) 4.5 mcg, 100 — Recall or enforcement action
No rationale yet.
10/09/2026
Fluphenazine HCl Elixir, USP, 10 mg per 2 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Onl — Recall or enforcement action
No rationale yet.
10/09/2026
Reliable -1 Laboratories, Sodium Chloride Hypertonicity Ophthalmic Solution, 5%, Sterile, 0.5 FL OZ (15 mL) bottles, Dis — Recall or enforcement action
No rationale yet.
10/09/2026
Lubricant Eye Drops-Cameron Pharmaceuticals, Carboxymethylcellulose Sodium 0.5%, Eye Lubricant, 0.5 FL OZ (15 mL) bottle — Recall or enforcement action
No rationale yet.
10/09/2026
AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops, Sterile, 0.5 FL OZ (15 mL) bottle, D — Recall or enforcement action
No rationale yet.
10/09/2026
Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye Drops (glycerin 0.25%, naphazoline hydrochloride 0.012%) with — Recall or enforcement action
No rationale yet.
10/09/2026
Fluphenazine HCl Elixir, USP, 20 mg per 4 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Onl — Recall or enforcement action
No rationale yet.
10/09/2026
AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops, Sterile, 0.5 FL OZ (15 mL) EACH, 1.0 — Recall or enforcement action
No rationale yet.
10/09/2026
Fluphenazine HCl Elixir, USP, 15 mg per 3 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Onl — Recall or enforcement action
No rationale yet.
10/09/2026
TRP The Relief Products* Gentle Eyes Lubricant Eye Drops, Carboxymethylcellulose sodium 0.5%, Sterile Eye Drops, 0.5 FL — Recall or enforcement action
No rationale yet.
10/09/2026

Reviewing 0

None.

Monitoring 0

None.

Research priority 0

None.

Rejected 0

None.

Established 0

None.