repair available Recalls

239 recalls tagged with “repair available”.

Health & Personal Care
HIGH
FDA DEVICE

Abiomed Impella Controller AIC Recall 2025 Affects 71 Units Across 6 Regions

Abiomed’s automated Impella Controller recall covers 71 units distributed across the US and international markets. The devices may have a Pump Driver Circuit Assembly that does not meet current specifications. This can reduce pump performance or trigger a pump stop with alarms. Clinicians and patients should follow manufacturer instructions and contact Abiomed or healthcare providers for guidance.

Abiomed
Specific Automated
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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 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 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 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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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 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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Recalled Firefly Safe & Green 32 oz. fuel bottles
HIGH
CPSC

Firefly Safe & Green 32 oz. Fuel Bottles Recalled for Poisoning Risk to Children

Firefly Fuel Inc. recalled Firefly Safe & Green 32 oz. bottles. The recall date is August 14, 2025. The fuel is sold in a clear bottle with a white cap and nozzle applicator. The product label shows Firefly brand, Safe & Green in green font, and claims Non-Toxic and Kosher. The nozzle applicator lacks child-resistant features, violating the Poison Prevention Packaging Act and the Federal Hazardous

Firefly Fuel
The recalled
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Health & Personal Care
HIGH
FDA DEVICE

Philips CT 6000 CT Scanner Recall 6-Unit for Table Descent Risk (2025)

Philips North America recalled 6 CT 6000 scanners, Model 728307, distributed worldwide including the United States. The patient support table may descend unexpectedly to the lowermost position due to ball screw misalignment after a replacement. Stop using the device immediately and follow manufacturer instructions. Contact Philips for guidance and next steps.

Philips
The patient
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Health & Personal Care
HIGH
FDA DEVICE

Philips CT Systems Recalled for Descent Hazard In 210-Unit Worldwide Distribution (2025)

Philips North America recalls 210 CT systems worldwide after reports that the patient support couch may descend unexpectedly to the lowest position following a replacement. Philips issued a recall dated 2025-08-13 with active status. The recall number is Z-2598-2025. Stop using immediately and follow manufacturer instructions.

Philips North America
The patient
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Health & Personal Care
HIGH
FDA DEVICE

Penner Patient Care Bathing Spa Devices Recall for Missing Unique Device Identifier (Z-1500-2026)

Penner Patient Care recalled 643 devices nationwide after the FDA flagged missing unique device identifiers. The recall affects a broad range of Penner Pacific Bathing Spa models. The device lacks a unique device identifier, posing regulatory and traceability concerns. Stop using the device and follow recall instructions from Penner Patient Care or a healthcare provider.

Penner Patient Care
The device
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Health & Personal Care
HIGH
FDA DEVICE

Max Mobility/Permobil Recalls 25,389 MX2+ SpeedControl Dial Units (2025)

Max Mobility LLC and Permobil recalled 25,389 MX2-3DC SpeedControl Dial units used with the SmartDrive MX2+ wheelchair power assist. A faulty electrical connection between the speed control dial and the wheelchair motor can cause loss of control. Users should stop using the device immediately and follow the manufacturer’s recall instructions for next steps.

Max Mobility
Due to
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Health & Personal Care
HIGH
FDA DRUG

Glenmark Carvedilol 25 mg Recall for Nitrosamine Impurity Affects 4,800 Bottles (2025)

Glenmark Pharmaceuticals recalls 4,800 bottles of Carvedilol 25 mg tablets distributed nationwide in the USA. The recall cites CGMP deviations and a nitrosamine impurity exceeding the Acceptable Intake Level. Consumers should stop using the product and contact Glenmark or their healthcare provider for guidance.

Glenmark Pharmaceuticals
CGMP Deviations:
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Health & Personal Care
HIGH
FDA DEVICE

SeaSpine Orthopedics Recalled 74 Reef TA Inserter Instruments for Reef Interbody System (2025)

SeaSpine Orthopedics recalled 74 Reef TA Inserter instruments used with the Reef Interbody System, distributed worldwide to hospitals and surgical centers. The inserter may cause difficulty disengaging the implant or improper positioning, prolonging surgery and possibly requiring intraoperative revision. Hospitals and surgeons should stop using the device and follow recall instructions from SeaSpn

SeaSpine Orthopedics
Inserter, used
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