These recalls involve products that pose serious risks of injury or death. Check if you own any of these products and take immediate action if needed.

High Risk Recalls

1,488 critical product recalls that require immediate attention. These products have been identified as posing serious safety hazards.

What to do if you own a recalled product:

  1. Stop using the product immediately
  2. Keep the product away from children
  3. Follow the remedy instructions provided
  4. Contact the manufacturer for a refund or replacement
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 Pacemaker Due to High Battery Risk

Boston Scientific recalled 3,146 units of the L209 PROPONENT DR (VDD) SL Pacemaker on August 20, 2025. The recall addresses a software issue that may cause device malfunction in ambulatory settings. Patients should stop using the device and follow manufacturer instructions immediately.

Boston Scientific
Software to
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HIGHFDA DEVICE

Boston Scientific Recalls Pacemaker Over Software Hazard

Boston Scientific recalled 10,833 units of its L121 ESSENTIO DR EL Pacemaker on August 20, 2025. The recall addresses a software issue that could prevent the device from operating correctly in certain conditions. Patients and healthcare providers must stop using the device immediately.

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 ALTRUA 2 Pacemaker Over Safety Software

Boston Scientific recalled 4,841 ALTRUA 2 SR SL pacemakers on August 20, 2025. The recall stems from a software issue that may prevent proper device function in patients. Users should stop using the device immediately and follow manufacturer instructions.

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 ESSENTIO SR SL MRI Pacemaker Over Safety Software Issue

Boston Scientific recalled 61,700 ESSENTIO SR SL MRI Pacemakers on August 20, 2025, due to a software issue. The software failure can lead to the device entering Safety Mode unexpectedly in high battery impedance situations. Patients must stop using the device immediately and follow recall instructions from their healthcare provider.

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 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 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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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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