1,120 recalls tagged with “electrical 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 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 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 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 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 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 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 recalled 28,911 pacemakers worldwide due to a software flaw in Safety Architecture that could prevent Safety Mode when battery impedance is high. The recall covers ACCOLADE family devices and VISIONIST and VALITUDE CRT-Ps. Patients should stop using the device immediately and follow the recall letter instructions.
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 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 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 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 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 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.
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.
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.
B. Braun Medical Inc. recalls 47,148 containers of 0.9% Sodium Chloride Injection USP nationwide after detecting particulate matter. The Class I recall affects bottles with NDC 0264-7800-09. Stop using and contact providers for guidance.
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.
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.
Maquet Cardiovascular recalled 16,512 Heartstring III Proximal Seal Systems due to three identified failure modes. The device may fail to load, deploy, or provide adequate hemostasis during use. Healthcare providers must stop using the device immediately and contact the manufacturer for guidance.