fda regulated Recalls

1,264 recalls tagged with “fda regulated”.

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 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 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 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 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 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 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 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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Food & Beverages
HIGH
FDA FOOD

Great American Seafood Imports Co. Frozen Raw Shrimp Recall Covers 11,081 Cases (2025)

Great American Seafood Imports Co. recalled 11,081 cases of frozen raw shrimp sold under multiple brands. The recall cites insanitary production conditions that may have allowed Cesium-137 contamination. Consumers who purchased the 2-pound bags should not eat the product and should contact the company for refunds or replacements via email.

Great American Seafood Imports Co.
Product manufactured
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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

Amneal Chlorpromazine Hydrochloride Recall 2025: 14,923 Bottles Over Packaging Contamination

Amneal Pharmaceuticals recalled 14,923 bottles of Chlorpromazine Hydrochloride 100 mg tablets sold nationwide in the United States. A packaging coil used in the product’s packaging was found to contain a microorganism. No microorganism was detected on any tablets. Stop using the product and contact Amneal or your healthcare provider for guidance.

Chlorpromazine Hydrochloride
Presence of
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Health & Personal Care
HIGH
FDA DRUG

B. Braun Lactated Ringers Injection 46,032 Containers Recalled Over Particulate Matter

B. Braun Medical recalled 46,032 containers of Lactated Ringers Injection USP sold nationwide in the United States. The recall cites the presence of particulate matter in the 1000 mL IV solution. Consumers should stop using the product immediately and contact their healthcare provider or B. Braun for guidance.

B Braun Medical
Presence of
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Health & Personal Care
HIGH
FDA DRUG

Amneal Chlorpromazine Hydrochloride 25 mg 100-count Recalled in 2025 for Packaging Contamination

Amneal Pharmaceuticals LLC is recalling 7,228 bottles of CHLORPROMAZINE HYDROCHLORIDE tablets sold nationwide in the United States. Packaging coils used in the bottles tested positive for a microorganism, though no tablets were contaminated. Stop using this product immediately and contact Amneal or your healthcare provider for guidance.

Chlorpromazine Hydrochloride
Presence of
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Health & Personal Care
HIGH
FDA DRUG

Chlorpromazine Hydrochloride 200 mg Recall Expanded After Packaging Contamination Found in 3,363 JDS

Amneal Pharmaceuticals products containing chlorpromazine hydrochloride are recalled nationwide after the FDA-linked notice identifies a foreign substance in packaging material. No tablets were contaminated. The recall was issued August 18, 2025 and updated September 10, 2025. Consumers and healthcare providers should stop using the affected lots immediately and contact Amneal for guidance.

Chlorpromazine Hydrochloride
Presence of
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Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific ICEfx Cryoablation System Recalled for 19 Units Worldwide (2025)

Boston Scientific recalled 19 ICEfx Cryoablation System units worldwide, including the United States, Canada, France, Germany and Italy. The recall concerns desiccant tube subassemblies with end caps that were not tightened. Clinicians and patients should stop using the device immediately and follow recall instructions issued by the manufacturer.

Boston Scientific
Certain desiccant
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Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific Preventive Maintenance Kit SPRPM8000 Recalled for Hazardous Defect

Boston Scientific recalled 1 unit of the Preventive Maintenance Kit SPRPM8000 after certain desiccant tubes were built with incorrectly tightened end caps. This assembly defect can lead to device malfunction, posing a serious risk to patients. Healthcare providers and patients should stop using the device immediately and follow recall instructions from the manufacturer.

Boston Scientific
Certain desiccant
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Health & Personal Care
HIGH
FDA DEVICE

Aesculap ELAN 4 Fixed Duraguard Recalled for Mislabeling (1 Unit, 2025)

Aesculap AG is recalling one unit of the ELAN 4 Fixed Duraguard Standard, model GB942R, distributed in the United States to Missouri and internationally to multiple countries. The recall addresses mislabeling where the Standard was labeled as Long and the Long was labeled as Standard. Patients and healthcare providers should stop using this device immediately and follow the manufacturer’s recall指南

Aesculap AG
Mislabeling. The
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Tag Statistics

Total Recalls
1,264

Related Tags

electrical hazardimmediate actionstop use immediatelyreplacement availablelithium batterybattery poweredcpsc regulatedtip over riskreturn for refundsuffocation riskinfant productadult product