1,030 recalls tagged with “electrical hazard”.
Folsom Metal Products recalled 3,790 distraction pins on August 21, 2025. The recall affects all lots distributed from August 1, 2020, to July 30, 2025. The labeling lacks a validated shelf life, posing a high hazard risk.
Abbott Point Of Care recalled 6,115,950 i-STAT EG7+ cartridges on August 21, 2025. The recall stems from a lack of 510(k) premarket clearance for updated measurement ranges. This issue affects the accuracy of potassium and ionized calcium tests, posing a high risk to patients.
Folsom Metal Products recalled 490 units of its 16 mm distraction pin on August 21, 2025. The recall affects devices with unvalidated shelf life labeling. Patients and healthcare providers must stop using the device immediately.
Abbott Point Of Care recalled 547,250 i-STAT EG6+ cartridges on August 21, 2025. The recall stems from a lack of 510(k) premarket clearance for updated sample types and measurement ranges. Healthcare providers and patients must stop using these cartridges immediately.
Medline Industries recalled 828 units of catheter kits on August 21, 2025, due to potential shape retention issues. The affected products include Model Numbers DYNJ0415366P and DYNJ0415366Q. This recall poses a serious risk to patient safety.
Bard Peripheral Vascular recalled 1,725 Venclose digiRF Generators on August 21, 2025. The recall stems from software version 3.35 generating false positives for catheter defects. This issue can lead to improper device functionality during clinical use.
Abiomed recalled 71 Automated Impella Controllers on August 20, 2025. The devices may fail to perform correctly, leading to pump stoppage. Healthcare providers and patients must stop using these devices immediately.
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 10,833 units of its L121 ESSENTIO DR EL Pacemaker on August 20, 2025. The recall addresses a software issue that could prevent the device from operating correctly in certain conditions. Patients and healthcare providers must stop using the device 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 7,488 ACCOLADE DR EL pacemakers on August 20, 2025. The recall addresses a software issue that may prevent the device from entering Safety Mode. Patients should stop using the device immediately and follow recall instructions.
Boston Scientific recalled 1,380 PROPONENT SR SL pacemakers on August 20, 2025. The recall addresses a software issue that may prevent safety mode activation in ambulatory settings. Healthcare providers and patients must stop using the devices immediately.
Boston Scientific recalled 63,851 Proponent DR EL MRI Pacemakers on August 20, 2025. The recall addresses a software issue that may prevent proper device function in certain conditions. Patients must stop using the device and follow manufacturer instructions immediately.
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 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 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 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.
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 4,055 ALTRUA 2 DR SL Pacemakers on August 20, 2025, due to a software issue. This software can prevent the device from initiating Safety Mode in certain conditions. Patients should stop using the device immediately and follow recall instructions.
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.