All Product Recalls

Browse through 1,540 product recalls and safety alerts. Filter by hazard level, status, or search for specific products.

HIGHFDA DEVICE

Boston Scientific Recalls Pacemaker Over Software Issue

Boston Scientific recalled 3,592 units of the Model L221 PROPONENT DR EL Pacemaker on August 20, 2025. The recall addresses a software issue that may prevent proper device functioning due to high battery impedance. Patients and healthcare providers must stop using the device immediately and follow the recall instructions.

Boston Scientific
Software to
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HIGHFDA DEVICE

Boston Scientific Recalls ALTRUA 2 DR Pacemaker Over Safety Hazard

Boston Scientific recalled 4,055 ALTRUA 2 DR SL Pacemakers on August 20, 2025, due to a software issue. This software can prevent the device from initiating Safety Mode in certain conditions. Patients should stop using the device immediately and follow recall instructions.

Boston Scientific
Software to
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HIGHFDA DEVICE

Boston Scientific Recalls Pacemakers Due to Software Hazard

Boston Scientific recalled 106,536 PROPONENT DR SL MRI pacemakers on August 20, 2025, due to software issues. The recall affects multiple models and aims to prevent safety mode initiation in ambulatory settings. Patients must stop using these devices immediately and follow the manufacturer's instructions.

Boston Scientific
Software to
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HIGHFDA DEVICE

Boston Scientific Recalls Pacemakers Over Software Safety Risk

Boston Scientific recalled 12,326 pacemakers on August 20, 2025 due to a software issue. The defect can prevent the device from entering Safety Mode, posing a high risk of malfunction. Patients should stop using the devices and follow recall procedures immediately.

Boston Scientific
Software to
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HIGHFDA DEVICE

Boston Scientific Recalls VALITUDE CRT-P EL MRI Pacemakers Due to Safety Hazard

Boston Scientific recalled 28,911 VALITUDE CRT-P EL MRI pacemakers on August 20, 2025, due to a software issue that may prevent proper device function. The recall affects specific models from the ACCOLADE family of devices. Patients and healthcare providers should stop using these devices immediately.

Boston Scientific
Software to
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HIGHFDA DEVICE

Boston Scientific Recalls Proponent DR EL MRI Pacemaker Due to Hazard

Boston Scientific recalled 63,851 Proponent DR EL MRI Pacemakers on August 20, 2025. The recall addresses a software issue that may prevent proper device function in certain conditions. Patients must stop using the device and follow manufacturer instructions immediately.

Boston Scientific
Software to
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HIGHFDA DEVICE

Boston Scientific Recalls ESSENTIO DR SL Pacemaker Over Safety Risk

Boston Scientific recalled 22,714 ESSENTIO DR SL pacemakers on August 20, 2025. Software updates are necessary to prevent initiation of Safety Mode due to high battery impedance. The recall affects multiple models including the ACCOLADE and VISIONIST series.

Boston Scientific
Software to
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HIGHFDA DEVICE

Boston Scientific Recalls ACCOLADE SR SL Pacemakers Over Software Issue

Boston Scientific recalled 16,077 ACCOLADE SR SL pacemakers on August 20, 2025. The recall addresses a software issue that may prevent the device from entering Safety Mode in high battery impedance states. Patients must stop using the device immediately and follow manufacturer's instructions.

Boston Scientific
Software to
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HIGHFDA DEVICE

Boston Scientific Recalls VALITUDE Pacemaker Over Software Issue

Boston Scientific recalled 3,620 VALITUDE CRT-P pacemakers on August 20, 2025, due to a software flaw. The issue may prevent the device from operating correctly in ambulatory settings. Patients and healthcare providers must stop using the device immediately.

Boston Scientific
Software to
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HIGHFDA DEVICE

Boston Scientific Recalls Pacemakers Due to Software Hazard

Boston Scientific recalled 41,191 pacemakers on August 20, 2025, due to a software issue that may prevent proper safety functions. The recall affects several models in the ACCOLADE and VISIONIST families of devices. Patients should stop using the devices immediately and follow manufacturer instructions.

Boston Scientific
Software to
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HIGHFDA DRUG

Lannett Company Recalls Dextroamphetamine Tablets Over Foreign Tablet Risk

Lannett Company recalled 4,848 bottles of Dextroamphetamine tablets on August 19, 2025. The recall stems from the presence of a foreign tablet in some bottles. This poses a significant risk to consumers who may inadvertently take the incorrect dosage.

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate
Presence of
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HIGHFDA FOOD

Frozen Cooked Shrimp Recalled Due to Cesium-137 Contamination

Best Yet, Arctic Shores, and Great American branded frozen cooked shrimp were recalled on August 19, 2025, due to potential contamination with Cesium-137. The recall affects 11,081 cases distributed across nine states including California and Virginia. Consumers should stop using these products immediately and contact the manufacturer for refunds.

Best Yet
Product manufactured
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HIGHFDA FOOD

Hershey Creamery Recalls Ice Cream Due to Coliform Contamination

Hershey Creamery recalled 81 cans of Green Mint Chip Ice Cream on August 19, 2025. The product tested positive for elevated coliform counts during routine testing. Consumers should not consume this product and should seek a refund or replacement.

HERSHEY CREAMERY
Product tested
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HIGHFDA DRUG

Amneal Pharmaceuticals Recalls Chlorpromazine Tablets Over Contamination Risk

Amneal Pharmaceuticals recalled 13,130 bottles of Chlorpromazine Hydrochloride Tablets on August 18, 2025, due to contamination concerns. The recall affects specific lots identified by their lot numbers AM240147, AM240148, AM240664, and AM240665. Consumers should stop using the tablets immediately and contact their healthcare provider for further guidance.

Chlorpromazine Hydrochloride
Presence of
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HIGHFDA DEVICE

Boston Scientific Recalls Cryoablation System Over Safety Hazard

Boston Scientific recalled 19 units of the ICEfx Cryoablation System on August 18, 2025. The recall stems from improperly tightened end caps on certain desiccant tube subassemblies. Patients and healthcare providers should stop using the device immediately.

Boston Scientific
Certain desiccant
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