185 recalls tagged with “federal law violation”.
Siemens Medical Solutions USA recalled 30 units of the MAGNETOM Skyra fit MRI system on August 28, 2025. The recall addresses a potential ice blockage in the magnet venting system that could lead to a helium leak. The device is distributed worldwide, including the US and multiple countries.
Siemens Medical Solutions USA recalled 18 MAGNETOM Skyra Fit BioMatrix MRI machines on August 28, 2025. The recall addresses a potential ice blockage in the magnet venting system, which could lead to helium gas leaks. Users must stop using the devices immediately and follow recall instructions.
Siemens Medical Solutions USA recalled 30 MRI systems on August 28, 2025 due to a risk of helium leaks. The recall affects the MAGNETOM Verio Dot model number 10684333. The potential ice blockage in the venting system could lead to a pressure build-up and rupture.
Siemens Medical Solutions USA recalled 46 MAGNETOM Verio Dot systems on August 28, 2025. The recall stems from a risk of ice blockage in the magnet venting system. This could lead to a helium leak, posing serious safety hazards.
American Health Packaging recalled 1,062 cartons of Chlorpromazine Hydrochloride Tablets on August 27, 2025. The recall stems from the detection of a micro-organism in auxiliary packaging materials. No micro-organism was found on the tablets themselves, but consumers should stop using the product 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 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 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 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 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 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.
Aesculap AG recalled three surgical instruments on August 18, 2025, due to mislabeling issues. The ELAN 4 FIXED DURAGUARD LONG was incorrectly labeled as "Standard" and vice versa. The recall affects devices distributed in the U.S. and several international markets.
Beckman Coulter recalled the UniCel DxH 690T COULTER Cellular Analysis System on August 13, 2025. Erroneously high hemoglobin results may occur in patients with elevated white blood cell counts. Healthcare providers and patients must stop using the device immediately.
Philips recalled 285 CT systems on August 13, 2025, due to a risk of patient support tables descending unexpectedly. The recall affects model numbers 728321, 728323, and 728326. Users should stop using the devices immediately and follow manufacturer instructions.
Philips recalled 210 Brilliance iCT CT systems on August 13, 2025. A misalignment in the ball screw may cause the patient support table to descend unexpectedly. Patients and healthcare providers must stop using the device immediately.
Change Healthcare recalled 12 programs of its Radiology Solutions software version 14.2.2 on August 13, 2025. A software issue may prevent radiology reports from displaying fully. Healthcare providers and patients must stop using the software immediately.
Baker's Authority recalled 70 units of Graham Cracker Meal on August 12, 2025, due to undeclared allergens. The product lacks proper labeling for wheat and soy, posing a serious health risk to allergic consumers. These items were distributed across multiple states including NY, CA, and TX.
Agilent Technologies recalled 67 units of FLEX Monoclonal Mouse Anti-Human CD20cy on August 11, 2025. The recall stems from the potential for weak staining leading to false negative results in B-cell identification. Healthcare providers must cease use immediately and follow recall instructions.