1,716 recalls tagged with “cpsc regulated”.
Boston Scientific recalled 61,700 ESSENTIO SR SL MRI Pacemakers on August 20, 2025, due to a software issue. The software failure can lead to the device entering Safety Mode unexpectedly in high battery impedance situations. Patients must stop using the device immediately and follow recall instructions from their healthcare provider.
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 recalled 190,088 ESSENTIO DR EL MRI Pacemakers on August 20, 2025. A software issue may prevent proper device operation in ambulatory settings. Patients must stop using the device immediately and follow recall instructions.
Boston Scientific recalled 1,050 cardiac pacemakers on August 20, 2025. The recall affects the VISIONIST and ACCOLADE families of devices due to a software issue. Patients must stop using the devices immediately to prevent potential safety risks.
Boston Scientific recalled 41,191 pacemakers on August 20, 2025, due to a software issue that may prevent proper safety functions. The recall affects several models in the ACCOLADE and VISIONIST families of devices. Patients should stop using the devices immediately and follow manufacturer instructions.
Boston Scientific recalled 3,620 VALITUDE CRT-P pacemakers on August 20, 2025, due to a software flaw. The issue may prevent the device from operating correctly in ambulatory settings. Patients and healthcare providers must stop using the device immediately.
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 recalled 22,714 ESSENTIO DR SL pacemakers on August 20, 2025. Software updates are necessary to prevent initiation of Safety Mode due to high battery impedance. The recall affects multiple models including the ACCOLADE and VISIONIST series.
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 recalled 223,163 ESSENTIO DR SL MRI pacemakers on August 20, 2025. The recall addresses a software issue that could prevent the device from functioning properly in certain conditions. Users should stop using the device immediately and follow the manufacturer’s instructions.
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 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 recalled 3,592 units of the Model L221 PROPONENT DR EL Pacemaker on August 20, 2025. The recall addresses a software issue that may prevent proper device functioning due to high battery impedance. Patients and healthcare providers must stop using the device immediately and follow the recall instructions.
Boston Scientific recalled 34,180 ACCOLADE DR EL MRI pacemakers on August 20, 2025. The recall addresses a software issue that may prevent proper function in ambulatory settings. Patients should stop using the devices immediately and contact their healthcare provider.
Amneal Pharmaceuticals recalled 13,130 bottles of Chlorpromazine Hydrochloride Tablets on August 18, 2025, due to contamination concerns. The recall affects specific lots identified by their lot numbers AM240147, AM240148, AM240664, and AM240665. Consumers should stop using the tablets immediately and contact their healthcare provider for further guidance.
B. Braun Medical, Inc. recalled 46,032 containers of Lactated Ringer's Injection on August 18, 2025. The recall follows reports of particulate matter found in the solution. This Class I recall affects products distributed nationwide in the U.S.
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.
B. Braun Medical Inc. recalled 47,148 containers of Sodium Chloride Injection on August 18, 2025. The recall follows the discovery of particulate matter in the product. Consumers and healthcare providers must stop using the injection immediately.
Aesculap AG recalled one unit of the ELAN 4 FIXED DURAGUARD STANDARD on August 18, 2025. The product was mislabeled, leading to potential use confusion. The recall affects distribution in the US and multiple international locations.
CORNEAT VISION recalled 180 units of EverPatch+ on August 18, 2025, due to a risk of conjunctival wound dehiscence. This defect may lead to early exposure of the surgical patch. The recall affects distribution across the United States and several countries.