Health & Personal Care
HIGH
FDA DEVICE
Frontier Devices Recalls 2,700 REF 301.914S1 14 mm Distraction Pins (2025)
Labeling includes shelf life that has not been validated.
Frontier Devices
Labeling includes
Drug Recalls Center
2,090 pharmaceutical and medication recalls tracked. Stay informed about FDA drug safety alerts, prescription medications, over-the-counter drugs, and dietary supplements.
2,090
Total Drug Recalls
24
High Risk Medications
FDA
Official Source
Important Medication Safety Information
- Do not stop taking prescribed medications without consulting your healthcare provider
- Contact your pharmacist or doctor if you have a recalled medication
- Check lot numbers carefully - not all batches may be affected
- Return recalled medications to your pharmacy for proper disposal
Looking for a specific drug? Use the search page to find recalls by medication name, manufacturer, or NDC number.
Health & Personal Care
HIGH
FDA DEVICE
Abbott Point Of Care i-STAT EG7+ Cartridges Recalled Over 6.1 Million Units in 2025
Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium and measurement ranges for pH and PO2.
Abbott Point Of Care
Lack of
Health & Personal Care
HIGH
FDA DEVICE
Abbott i-STAT CG8+ Cartridge Recall 2025: 8,962,450 Units
Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium and measurement ranges for pH and PO2.
Abbott Point Of Care
Lack of
Health & Personal Care
HIGH
FDA DEVICE
Frontier Devices 301.914S1 Distraction Pin Recall: 10,960 Units Due to Labeling Issue
Labeling includes shelf life that has not been validated.
Folsom Metal Products
Labeling includes
Health & Personal Care
HIGH
FDA DEVICE
Frontier Devices 301.916S1 16 mm Distraction Pin Recall Expanded (2025)
Labeling includes shelf life that has not been validated.
Frontier Devices
Labeling includes
Health & Personal Care
HIGH
FDA DEVICE
Bard Peripheral Vascular Venclose DigiRF Generator Recall Affects 1,725 Units Worldwide
Bard Peripheral Vascular
Software version
Health & Personal Care
HIGH
FDA DEVICE
Medline Recalls 828 Valve Pack-LF Cannula Kits DYNJ0415366P and DYNJ0415366Q (2025)
The kits contain certain lots of cannula products where the catheter may not retain its shape.
Medline Industries
The kits
Health & Personal Care
HIGH
FDA DRUG
96 Bottles of Sulfamethoxazole and Trimethoprim Tablets Recalled for Micro-Organism Contamination
Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
SULFAMETHOXAZOLE AND TRIMETHOPRIM
Presence of
Health & Personal Care
HIGH
FDA DEVICE
Abiomed Impella Controller AIC Recall 2025 Affects 71 Units Across 6 Regions
Specific Automated Impella Controllers (AICs) that have a Pump Driver Circuit Assembly do not meet current specifications. This may lead to decreased pump performance or pump stop and trigger an Impella Failure or Impella Stopped Controller Failure alarm.
Abiomed
Specific Automated
Health & Personal Care
HIGH
FDA DRUG
Baxter Acetaminophen Injection 1000 mg/100 mL Recall for Discoloration
Baxter Healthcare’s Acetaminophen Injection 1000 mg/100 mL is recalled. The nationwide recall covers 13,000 containers with lot 24A27G66 and expiring 12/31/2025. The FDA lists discoloration as the hazard. Stop using and contact Baxter or a healthcare provider.
Baxter Healthcare Corporation
Discoloration
Health & Personal Care
HIGH
FDA DRUG
Carvedilol Tablets 12.5 mg Recall Expanded for NNCI Impurity Above FDA Limit (2025)
The FDA recalls 26,628 cartons of Carvedilol Tablets USP 12.5 mg distributed nationwide. The product fails CGMP standards due to NNCI impurity exceeding FDA limits. Stop using and contact The Harvard Drug Group LLC and Rugby Laboratories for guidance.
Major Pharmaceuticals
CGMP Deviations:
Health & Personal Care
HIGH
FDA DEVICE
Boston Scientific L221 PROPONENT DR EL Pacemaker Recalled for Safety Software Issue (2025)
Boston Scientific
Software to
Health & Personal Care
HIGH
FDA DEVICE
Boston Scientific Pacemakers Recalled for Safety Architecture Software Issue (41,009 Units, 2025)
Boston Scientific
Software to
Health & Personal Care
HIGH
FDA DEVICE
Boston Scientific Pacemaker Recall 2025 Affects ACCOLADE, ALTRUA 2 and CRT-P Devices Worldwide
Boston Scientific
Software to
Health & Personal Care
HIGH
FDA DEVICE
Boston Scientific Pacemakers Recalled for High Battery Impedance Safety Software
Boston Scientific
Software to
Health & Personal Care
HIGH
FDA DEVICE
Boston Scientific Pacemaker Recall Affects 3,620 Units Worldwide in 2025
Boston Scientific
Software to
Health & Personal Care
HIGH
FDA DEVICE
Boston Scientific Pacemakers Recalled Over Software Issue in Safety Architecture (2025)
Boston Scientific
Software to
Health & Personal Care
HIGH
FDA DEVICE
Boston Scientific Pacemakers Recalled in Class I High-Hazard Software Issue Affecting ACCOLADE, VERS
Boston Scientific
Software to
Health & Personal Care
HIGH
FDA DEVICE
Boston Scientific ESSENTIO DR EL MRI Pacemaker Recalled for Software Safety Issue (190,088 Units, 0)
Boston Scientific
Software to
Health & Personal Care
HIGH
FDA DEVICE
Boston Scientific Pacemakers Recall 1,380 Units Over Software Safety Issue
Boston Scientific
Software to
Health & Personal Care
HIGH
FDA DEVICE
Boston Scientific Pacemaker Recall 2025 Affects 41,191 ACCOLADE, Visionist and Valitude Devices
Boston Scientific
Software to
Health & Personal Care
HIGH
FDA DEVICE
Boston Scientific Pacemakers Recalled in 2025 for Safety Architecture Software Flaw
Boston Scientific
Software to
Health & Personal Care
HIGH
FDA DEVICE
Boston Scientific Pacemakers Recall 28,911 U128 ACCOLADE, VISIONIST VALITUDE CRT-P Devices (2025)
Boston Scientific
Software to
Health & Personal Care
HIGH
FDA DEVICE
Boston Scientific L211 PROPONENT DR SL MRI Pacemakers Recalled Worldwide (106,536 Units, 2025)
Boston Scientific
Software to
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