All Product Recalls

Browse through 2,852 product recalls and safety alerts. Filter by hazard level, status, or search for specific products.

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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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
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Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific Pacemakers Recall 28,911 U128 ACCOLADE, VISIONIST VALITUDE CRT-P Devices (2025)

Boston Scientific recalled 28,911 pacemakers worldwide due to a software flaw in Safety Architecture that could prevent Safety Mode when battery impedance is high. The recall covers ACCOLADE family devices and VISIONIST and VALITUDE CRT-Ps. Patients should stop using the device immediately and follow the recall letter instructions.

Boston Scientific
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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
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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
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Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific Pacemakers Recalled for Software Safety Issue Affecting 12,326 Units (2025)

Boston Scientific recalled 12,326 ACCOLADE, Visionist and Valitude pacemakers worldwide after a software issue was identified. The software enhances Safety Architecture and may prevent initiation of Safety Mode when battery impedance is high. Patients should contact their healthcare provider immediately and follow the manufacturer’s recall instructions.

Boston Scientific
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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
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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 Pacemakers Recalled for Software Flaw That Could Block Safety Mode

Boston Scientific recalled 32,695 ACCOLADE family pacemakers and related CRT-Ps after discovering software that could prevent entering Safety Mode when battery impedance is high. The recall is worldwide and classified as Class I with a high hazard level. Patients should stop using the devices and follow manufacturer instructions. Contact Boston Scientific or a healthcare provider for guidance.

Boston Scientific
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Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific L110 ESSENTIO SR SL MRI Pacemaker Recalled in 2025 for 61,700 Units

Boston Scientific recalled 61,700 pacemakers worldwide after a software issue was identified. The device safety architecture could fail to initiate Safety Mode when battery impedance is high. Healthcare providers were advised to stop using the affected devices and follow recall instructions from the manufacturer.

Boston Scientific
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Health & Personal Care
HIGH
FDA DEVICE

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

Boston Scientific recalled 3,146 pacemakers worldwide after identifying a software defect that could prevent Safety Mode initiation in an ambulatory setting. Devices include ACCOLADE family models and VISIONIST and VALITUDE CRT-Ps. Patients should stop using affected devices and follow manufacturer instructions.

Boston Scientific
Software to
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Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific L221 PROPONENT DR EL Pacemaker Recalled for Safety Software Issue (2025)

Boston Scientific is recalling 3,592 pacemakers sold worldwide through hospitals and clinics in 2025. A software feature intended to enhance Safety Architecture may fail to initiate Safety Mode in ambulatory settings due to high battery impedance. Patients and healthcare providers should stop using these devices immediately and follow the recall instructions.

Boston Scientific
Software to
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Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific Pacemakers Recalled in Class I High-Hazard Software Issue Affecting ACCOLADE, VERS

Boston Scientific recalled 7,488 pacemakers worldwide due to software that could impair Safety Mode initiation in high-battery-impedance states. Devices include ACCOLADE family models and CRT-Ps such as VISIONIST and VALITUDE. The issue stems from software designed to enhance Safety Architecture. Patients should follow manufacturer instructions and contact providers immediately.

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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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 Pacemaker Recall 2025 Affects 41,191 ACCOLADE, Visionist and Valitude Devices

Boston Scientific is recalling 41,191 ACCOLADE family pacemakers and Visionist and Valitude CRT-P devices worldwide. The software to enhance Safety Architecture could prevent Safety Mode activation in ambulatory settings when a high battery impedance state is present. Patients should stop using the device and contact their healthcare provider for instructions.

Boston Scientific
Software to
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Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific L211 PROPONENT DR SL MRI Pacemakers Recalled Worldwide (106,536 Units, 2025)

Boston Scientific recalls 106,536 ACCOLADE family pacemakers sold worldwide through healthcare providers. The recall centers on software designed to strengthen Safety Architecture that could prevent initiating Safety Mode in patients with a high battery impedance state. Patients should stop using the device immediately and contact their clinician or Boston Scientific for instructions.

Boston Scientific
Software to
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Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific Pacemaker Recall 2025 Affects ACCOLADE, ALTRUA 2 and CRT-P Devices Worldwide

Boston Scientific recalled 4,841 pacemakers worldwide on 2025-08-20 after a software issue could prevent Safety Mode activation in ambulatory settings. The affected devices include ACCOLADE family pacemakers and VISIONIST and VALITUDE CRT-Ps. Patients and healthcare providers should stop using the device immediately and follow the recall instructions in the notification letter.

Boston Scientific
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