cpsc regulated Recalls

2,056 recalls tagged with “cpsc regulated”.

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 for Safety-Mode Initiation Software Flaw (2025)

Boston Scientific recalled 1,050 pacemaker units worldwide on Aug 20, 2025. The recall covers ACCOLADE family devices and Visionist and Valitude CRT-Ps. A software issue could prevent Safety Mode initiation in ambulatory settings. Patients should follow manufacturer guidance and contact their clinician immediately.

Boston Scientific
Software to
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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
Software to
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Health & Personal Care
HIGH
FDA DEVICE

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

Boston Scientific recalls 223,163 pacemakers worldwide due to software issues affecting Safety Architecture. The recall covers ACCOLADE, PROPONENT, ESSENTIO, ALTRUA 2 DR devices and VISIONIST and VALITUDE CRT-Ps. The defect prevents initiation of Safety Mode when battery impedance is high. Patients should stop using the device and follow manufacturer instructions.

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 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
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
Software to
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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
Software to
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Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific ESSENTIO DR EL MRI Pacemaker Recalled for Software Safety Issue (190,088 Units, 0)

Boston Scientific recalled 190,088 pacemakers worldwide, including ACCOLADE family devices and related CRT-Ps. The software to enhance Safety Architecture could prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state. Patients and healthcare providers should stop using these devices immediately and await manufacturer instructions by letter.

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 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 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
Software to
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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
Software to
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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 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
Software to
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Food & Beverages
HIGH
FDA FOOD

Best Yet, Arctic Shores, and Great American Frozen Shrimp Recalled for Cs-137 Contamination (2025)

Best Yet, Arctic Shores, and Great American frozen shrimp were recalled by Southwind Foods LLC dba Great American Seafood Imports Co. The recall cites insanitary production conditions that may have contaminated products with Cesium-137. Consumers who purchased these products should not consume them and should contact the company for refunds or replacements.

Best Yet
Product manufactured
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Health & Personal Care
HIGH
FDA DRUG

Lannett 10mg Dextroamphetamine Tablets Recalled for Foreign Tablet Contamination (2025)

Lannett Company Inc. recalls 4,848 bottles of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets. A bottle labeled 10 mg 100-count contained a 5 mg tablet. Two bottles were affected. Consumers and healthcare providers should stop using this product immediately. Contact Lannett or a healthcare provider for guidance.

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate
Presence of
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Tag Statistics

Total Recalls
2,056

Related Tags

electrical hazardimmediate actionreturn for refundfda regulatedplasticmetaladult productsuffocation risklaceration risktip over riskinfant productburn risk