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

2,247 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 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 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 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 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 ESSENTIO DR SL MRI Pacemaker Due to Software Risk

Boston Scientific recalled 223,163 ESSENTIO DR SL MRI pacemakers on August 20, 2025. The recall addresses a software issue that could prevent the device from functioning properly in certain conditions. Users should stop using the device immediately and follow the manufacturer’s instructions.

Boston Scientific
Software to
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HIGHFDA DEVICE

Boston Scientific Recalls Cardiac Pacemakers Over Safety Risk

Boston Scientific recalled 1,050 cardiac pacemakers on August 20, 2025. The recall affects the VISIONIST and ACCOLADE families of devices due to a software issue. Patients must stop using the devices immediately to prevent potential safety risks.

Boston Scientific
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HIGHFDA DEVICE

Boston Scientific Recalls Pacemakers Over High Battery Impedance Risk

Boston Scientific recalled 41,009 pacemakers on August 20, 2025, due to a software issue that could trigger Safety Mode. This affects the ACCOLADE family of devices, including the PROPONENT model. Patients should stop using these devices immediately and contact their healthcare provider.

Boston Scientific
Software to
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HIGHFDA FOOD

Toto Foods Recalls S'Mores Cookies Over Soy Allergy Risk

Toto Foods recalled 120,180 units of S'Mores Ooey Gooey Cookies on August 20, 2025. The product label conflicts regarding soy content pose a health risk to consumers with soy allergies. The cookies were distributed across 13 states including California and New York.

Toto Foods
Product label
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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
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