fda regulated Recalls

1,264 recalls tagged with “fda regulated”.

Health & Personal Care
HIGH
FDA DEVICE

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

Bard Peripheral Vascular recalled 1,725 Venclose digiRF Generators with software version 3.35. The recall centers on a catheter verification feature that can produce false positives and disable compatible EVSRF catheters. The worldwide distribution includes the United States. Patients and healthcare providers should stop using the device and await further instructions from the manufacturer.

Bard Peripheral Vascular
Software version
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Health & Personal Care
HIGH
FDA DEVICE

Abiomed Impella Controller AIC Recall 2025 Affects 71 Units Across 6 Regions

Abiomed’s automated Impella Controller recall covers 71 units distributed across the US and international markets. The devices may have a Pump Driver Circuit Assembly that does not meet current specifications. This can reduce pump performance or trigger a pump stop with alarms. Clinicians and patients should follow manufacturer instructions and contact Abiomed or healthcare providers for guidance.

Abiomed
Specific Automated
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Health & Personal Care
HIGH
FDA DRUG

96 Bottles of Sulfamethoxazole and Trimethoprim Tablets Recalled for Micro-Organism Contamination

Northwind Pharmaceuticals recalled 2,295 bottles of Sulfamethoxazole and Trimethoprim Tablets due to contamination risks. A foreign substance was detected in the packaging's auxiliary polyester coil, although no micro-organisms were found on the tablets. Consumers should stop using these products immediately and contact Northwind Pharmaceuticals for guidance.

SULFAMETHOXAZOLE AND TRIMETHOPRIM
Presence of
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Food & Beverages
HIGH
FDA FOOD

Itacate Foods CAMPSITE LENTEJAS Lentil Soup Recalled for Undeclared Yellow Dyes (154 Packages, 2025)

Itacate Foods recalled 154 packages of CAMPSITE LENTEJAS lentil soup sold in the United States after undeclared Yellow #5 and Yellow #6 were detected on the label. The issue involves undisclosed food color additives that could trigger allergic reactions in sensitive individuals. Consumers should discard the product and contact Itacate Foods for a refund or replacement.

Itacate Foods
Undeclared Yellow
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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
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Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific Pacemakers Recalled for Safety Architecture Software Issue (41,009 Units, 2025)

Boston Scientific recalled 41,009 pacemakers worldwide after a software flaw could prevent Safety Mode activation. The defect affects devices in the ACCOLADE family and several related models. Patients and healthcare providers should stop using the device immediately and follow recall instructions from the manufacturer.

Boston Scientific
Software to
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Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific Pacemakers Recalled for High Battery Impedance Safety Software

Boston Scientific recall affects 4,055 pacemakers worldwide. The recall covers ACCOLADE family devices, ALTRUA 2 DR SL/EL, VISIONIST and VALITUDE CRT-P models. Software intended to enhance Safety Architecture can fail to initiate Safety Mode in ambulatory settings. Patients should stop using the device and contact their clinician.

Boston Scientific
Software to
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Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific Pacemakers Recalled in 2025 for Safety Architecture Software Flaw

Boston Scientific recalled 34,180 devices worldwide on 2025-08-20 for ACCOLADE family pacemakers and CRT-Ps due to software that could prevent Safety Mode in high battery impedance conditions. The defect affects ACCOLADE, PROPONENT, ESSENTIO, ALTRUA 2 DR SL and EL models, plus VISIONIST and VALITUDE CRT-P devices. Patients should stop using the devices and follow recall instructions.

Boston Scientific
Software to
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Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific Pacemakers Recall 10,833 Units in 2025 Over Software Hazard

Boston Scientific recalled 10,833 pacemakers worldwide after a software issue could block Safety Mode in an ambulatory setting. The defect affects the ACCOLADE family and related devices, including VISIONIST and VALITUDE CRT-Ps. Patients and healthcare providers should stop using the device immediately and follow manufacturer instructions.

Boston Scientific
Software to
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Health & Personal Care
HIGH
FDA DEVICE

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

Boston Scientific recalls 223,163 pacemakers worldwide due to software issues affecting Safety Architecture. The recall covers ACCOLADE, PROPONENT, ESSENTIO, ALTRUA 2 DR devices and VISIONIST and VALITUDE CRT-Ps. The defect prevents initiation of Safety Mode when battery impedance is high. Patients should stop using the device and follow manufacturer instructions.

Boston Scientific
Software to
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Health & Personal Care
HIGH
FDA DEVICE

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

Boston Scientific recalled 1,380 pacemakers worldwide on August 20, 2025, due to software intended to enhance Safety Architecture. The devices include ACCOLADE family models and VISIONIST and VALITUDE CRT-Ps. The defect could prevent initiation of Safety Mode in ambulatory settings. Patients should stop using the devices and follow manufacturer instructions.

Boston Scientific
Software to
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Health & Personal Care
HIGH
FDA DEVICE

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

Boston Scientific recalls 3,620 pacemakers worldwide including VALITUDE CRT-P EL and ACCOLADE family devices. A software update is intended to prevent initiation of Safety Mode due to high battery impedance. Patients and clinicians should stop using affected devices and await manufacturer instructions.

Boston Scientific
Software to
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Health & Personal Care
HIGH
FDA DEVICE

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

Boston Scientific recalled 16,077 ACCOLADE family pacemakers distributed worldwide. The devices include ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 DR SL and EL pacemakers, plus VISIONIST and VALITUDE CRT-Ps. Patients and healthcare providers should stop using the devices immediately and follow the recall instructions.

Boston Scientific
Software to
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Health & Personal Care
HIGH
FDA DEVICE

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

Boston Scientific recalled 22,714 ACCOLADE family pacemakers worldwide on August 20, 2025. A software feature intended to enhance Safety Architecture may fail to initiate Safety Mode due to a high battery impedance state. Patients and healthcare providers should stop using this device immediately and await manufacturer instructions.

Boston Scientific
Software to
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Health & Personal Care
HIGH
FDA DEVICE

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

Boston Scientific recalled 63,851 L231 pacemakers worldwide on August 20, 2025. The recall covers the ACCOLADE family and related devices, including PROPONENT, ESSENTIO, ALTRUA 2 DR SL/EL, and VISIONIST and VALITUDE CRT-Ps. The software flaw could prevent Safety Mode from initiating when needed. Stop using the device and contact your healthcare provider for instructions immediately.

Boston Scientific
Software to
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Tag Statistics

Total Recalls
1,264

Related Tags

electrical hazardelectronicbattery poweredimmediate actionreturn for refundreplacement availablecpsc regulatednhtsa regulatedstop use immediatelyinfant productadult producttip over risk