All Product Recalls

Browse through 2,234 product recalls and safety alerts. Filter by hazard level, status, or search for specific products.

HIGHFDA DRUG

Baxter Healthcare Recalls Acetaminophen Injection Over Discoloration Risk

Baxter Healthcare Corporation recalled 13,000 containers of Acetaminophen Injection on August 20, 2025. The recall follows reports of discoloration that may affect product safety. Consumers should stop using the medication immediately and contact their healthcare providers for guidance.

Baxter Healthcare Corporation
Discoloration
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HIGHFDA FOOD

Itacate Foods Recalls Lentil Soup Over Undeclared Dyes

Itacate Foods recalled 154 packages of CAMPSITE LENTEJAS lentil soup on August 20, 2025. The recall follows the discovery of undeclared Yellow #5 and Yellow #6, which can cause allergic reactions. Consumers should stop using the product immediately.

Itacate Foods
Undeclared Yellow
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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 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 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 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 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 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 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 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 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 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 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 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 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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