electrical hazard Recalls

1,030 recalls tagged with “electrical hazard”.

Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific Recalls Pacemaker Due to High Battery Risk

Boston Scientific recalled 3,146 units of the L209 PROPONENT DR (VDD) SL Pacemaker on August 20, 2025. The recall addresses a software issue that may cause device malfunction in ambulatory settings. Patients should stop using the device and follow manufacturer instructions immediately.

Boston Scientific
Software to
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Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific Recalls Pacemakers Over Software Safety Risk

Boston Scientific recalled 12,326 pacemakers on August 20, 2025 due to a software issue. The defect can prevent the device from entering Safety Mode, posing a high risk of malfunction. Patients should stop using the devices and follow recall procedures immediately.

Boston Scientific
Software to
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Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific Recalls VALITUDE CRT-P EL MRI Pacemakers Due to Safety Hazard

Boston Scientific recalled 28,911 VALITUDE CRT-P EL MRI pacemakers on August 20, 2025, due to a software issue that may prevent proper device function. The recall affects specific models from the ACCOLADE family of devices. Patients and healthcare providers should stop using these devices immediately.

Boston Scientific
Software to
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Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific Recalls ALTRUA 2 Pacemaker Over Safety Software

Boston Scientific recalled 4,841 ALTRUA 2 SR SL pacemakers on August 20, 2025. The recall stems from a software issue that may prevent proper device function in patients. Users 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 ACCOLADE SR SL Pacemakers Over Software Issue

Boston Scientific recalled 16,077 ACCOLADE SR SL pacemakers on August 20, 2025. The recall addresses a software issue that may prevent the device from entering Safety Mode in high battery impedance states. Patients must stop using the device immediately and follow manufacturer's instructions.

Boston Scientific
Software to
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Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific Recalls Pacemakers Due to Software Hazard

Boston Scientific recalled 106,536 PROPONENT DR SL MRI pacemakers on August 20, 2025, due to software issues. The recall affects multiple models and aims to prevent safety mode initiation in ambulatory settings. Patients must stop using these devices immediately and follow the manufacturer's instructions.

Boston Scientific
Software to
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Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific Recalls Pacemakers Due to Software Malfunction

Boston Scientific recalled 32,695 pacemakers on August 20, 2025. The recall affects multiple models due to software that may prevent initiation of Safety Mode. This defect poses a high hazard level to patients who rely on these devices.

Boston Scientific
Software to
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Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific Recalls Pacemakers Over High Battery Impedance Risk

Boston Scientific recalled 41,009 pacemakers on August 20, 2025, due to a software issue that could trigger Safety Mode. This affects the ACCOLADE family of devices, including the PROPONENT model. Patients should stop using these devices immediately and contact their healthcare provider.

Boston Scientific
Software to
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Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific Recalls Cryoablation System Over Safety Hazard

Boston Scientific recalled 19 units of the ICEfx Cryoablation System on August 18, 2025. The recall stems from improperly tightened end caps on certain desiccant tube subassemblies. Patients and healthcare providers should stop using the device immediately.

Boston Scientific
Certain desiccant
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Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific Recalls Preventive Maintenance Kit Over Hazard Risk

Boston Scientific recalled one unit of the Preventive Maintenance Kit ICEFX on August 18, 2025. Certain desiccant tube subassemblies had improperly tightened end caps. This recall affects distribution in the US, Canada, France, Germany, and Italy.

Boston Scientific
Certain desiccant
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Health & Personal Care
HIGH
FDA DEVICE

CorNeat Vision Recalls Surgical Matrix Over High Dehiscence Risk

CorNeat Vision recalled 630 units of the EverPatch surgical matrix on August 18, 2025. The recall follows complaints of conjunctival wound dehiscence leading to potential exposure of the surgical patch. The product was distributed worldwide, including across numerous U.S. states.

CorNeat Vision
Reviewed complaints
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Health & Personal Care
HIGH
FDA DEVICE

Maquet Cardiovascular Recalls Heartstring III Occluder Due to Failure Risks

Maquet Cardiovascular recalled 32,867 units of the Heartstring III Proximal Seal System on August 15, 2025. Three failure modes can lead to inadequate hemostasis during procedures. Patients and healthcare providers must stop using this device immediately.

Maquet Cardiovascular
Three failure
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Health & Personal Care
HIGH
FDA DEVICE

Maquet Cardiovascular Recalls Heartstring III Occluder Due to High Risk

Maquet Cardiovascular recalled 16,512 Heartstring III Proximal Seal Systems due to critical failure modes. The recall affects devices distributed globally since August 15, 2025. Users must stop using the device immediately and follow manufacturer instructions.

Maquet Cardiovascular
Three failure
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Health & Personal Care
HIGH
FDA DEVICE

Exactech Recalls Reverse Shoulder Humeral Liners Over Safety Concerns

Exactech recalled 61,334 units of Reverse Shoulder Humeral Liners on August 15, 2025. The liners do not meet specified dimensional standards, posing a risk to patients. Healthcare providers and patients must stop using the devices immediately.

Exactech
Reverse Shoulder
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Health & Personal Care
HIGH
FDA DEVICE

ETHICON Recalls Tissue Control Device for Barb Non-Engagement Risk

ETHICON recalled 516 units of the STRATAFIX Spiral PDS Plus device on August 15, 2025. The recall follows reports of potential barb non-engagement that could affect surgical procedures. Healthcare providers and patients must stop using the device immediately.

ETHICON
Potential for
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Health & Personal Care
HIGH
FDA DEVICE

Mindray Recalls BeneVision N1 Patient Monitor Over Alarm Issues

Mindray DS USA, Inc. recalled 2,278 BeneVision N1 Patient Monitors on August 15, 2025. The monitors may activate an abnormal alarm pause, compromising patient safety. Health professionals must cease using these devices immediately and follow recall instructions.

Mindray DS USA, Inc.
Potential for
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Health & Personal Care
HIGH
FDA DEVICE

Exactech Recalls Reverse Shoulder Humeral Liners Over Hazard

Exactech recalled 11,542 reverse shoulder humeral liners on August 15, 2025. The devices have an articular surface position outside of the specified dimensions. This recall affects units distributed worldwide, including several U.S. states.

Exactech
Reverse Shoulder
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