Health & Personal Care Recalls

Frontier Devices 301.914S1 Distraction Pin Recall: 10,960 Units Due to Labeling Issue

Labeling includes shelf life that has not been validated.

Bard Peripheral Vascular Venclose DigiRF Generator Recall Affects 1,725 Units Worldwide

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.

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.

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.

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.

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.

Boston Scientific Pacemakers Recalled for Safety-Mode Initiation Software Flaw (2025)

Boston Scientific ESSENTIO DR EL MRI Pacemaker Recalled for Software Safety Issue (190,088 Units, 0)

Boston Scientific Pacemakers Recalled in Class I High-Hazard Software Issue Affecting ACCOLADE, VERS

Boston Scientific Pacemakers Recalled Over Software Issue in Safety Architecture (2025)

Boston Scientific Pacemakers Recalled for Software Flaw That Could Block Safety Mode

Boston Scientific L211 PROPONENT DR SL MRI Pacemakers Recalled Worldwide (106,536 Units, 2025)

Boston Scientific Pacemakers Recall 28,911 U128 ACCOLADE, VISIONIST VALITUDE CRT-P Devices (2025)

Boston Scientific Pacemaker L231 Recalled; 63,851 Units in 2025

Boston Scientific Recalls 22,714 ACCOLADE Pacemakers Over Software Safety Issue (2025)

Boston Scientific ACCOLADE Pacemakers Recall 16,077 Units Worldwide (L300)

Boston Scientific Pacemaker Recall Affects 3,620 Units Worldwide in 2025

Boston Scientific Pacemakers Recall 1,380 Units Over Software Safety Issue

Boston Scientific Pacemaker Recall 2025 Affects ACCOLADE, ALTRUA 2 and CRT-P Devices Worldwide