replacement available Recalls

1,215 recalls tagged with “replacement available”.

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 Pacemakers Recall 10,833 Units in 2025 Over Software Hazard

Boston Scientific recalled 10,833 pacemakers worldwide after a software issue could block Safety Mode in an ambulatory setting. The defect affects the ACCOLADE family and related devices, including VISIONIST and VALITUDE CRT-Ps. Patients and healthcare providers should stop using the device immediately and follow manufacturer instructions.

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

Boston Scientific ACCOLADE Pacemakers Recall 16,077 Units Worldwide (L300)

Boston Scientific recalled 16,077 ACCOLADE family pacemakers distributed worldwide. The devices include ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 DR SL and EL pacemakers, plus VISIONIST and VALITUDE CRT-Ps. Patients and healthcare providers should stop using the 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 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 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 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 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 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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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 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

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

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

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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Health & Personal Care
HIGH
FDA DEVICE

Aesculap AG Recalls ELAN 4 Fixed Duraguard Long Mislabeling Devices (GB943R)

Aesculap AG recalls the ELAN 4 Fixed Duraguard Long device, Model GB943R, after mislabeling errors were discovered. The U.S. distribution reached Missouri with international distribution to multiple countries. Healthcare providers should stop using the device immediately per manufacturer instructions.

Aesculap AG
Mislabeling. The
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Health & Personal Care
HIGH
FDA DEVICE

Corneat Vision EverPatch+ 180-Unit Recall for Scleral Patch Dehiscence Risk (2025)

CORNEAT VISION recalled 180 units of EverPatch+ scleral reinforcement patch worldwide after complaints of conjunctival wound dehiscence. The issue can lead to early exposure of the surgical patch. Clinicians and patients should stop using the device immediately and follow the manufacturer recall instructions.

CORNEAT VISION
Reviewed complaints
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Health & Personal Care
HIGH
FDA DEVICE

CorNeat Vision EverPatch Recalled for Conjunctival Wound Dehiscence Risk (630 Units, 2025)

CorNeat Vision recalled 630 EverPatch surgical matrices distributed worldwide, including in 28 U.S. states. Review of complaints found conjunctival wound dehiscence may lead to early exposure of the patch. Stop using the device immediately and follow the manufacturer’s recall instructions. Contact CORNEAT VISION, LTD. or your healthcare provider for guidance.

CorNeat Vision
Reviewed complaints
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Tag Statistics

Total Recalls
1,215

Related Tags

immediate actionstop use immediatelybattery poweredelectronicelectrical hazardfda regulatedreturn for refundlithium batterycpsc regulatedpet relatedinfant productadult product