Recalls
Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.
Minimum severity
AVID Medical is recalling 346 GYN Laparoscopy Packs due to discoloration caused by inadvertent resterilization. Affected kits were distributed in seven states.
BD Trucount Controls (Lot 85708) are being recalled due to incorrect standard deviation values that could compromise laboratory test accuracy.
Beckman Coulter is recalling 271 UniCel DxI 600/800 analyzers with incorrect motor current settings due to a software issue that could delay patient sample reporting.
AVID Medical recalls HVI Cardiac Robot Pack medical kits due to inadvertent resterilization of the CLEARIFY Visualization System, causing discoloration. No injuries reported.
AVID Medical recalled the LAP CHOLE PACK surgical kit after the CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized, causing discoloration of the device.
Draeger's SafeStar 60A Plus Filter may display slow CO2 curve increases during gas sampling, potentially causing inaccurate ventilation monitoring. The FDA is recalling 374,700 units distributed worldwide.
Draeger is recalling 669,838 SafeStar 90 Plus breathing filters due to a defect causing slow CO2 curve increases when gas samples are taken from the filter's sampling port.
The Automated Impella Controller (AIC) for left heart support may not detect a connected Impella pump, potentially preventing proper device operation. Approximately 11,031 units are affected worldwide.
HME TwinStar HEPA Plus Filters, made by Draeger, are recalled due to reports of slow CO2 curve increases when gas samples are taken from the filter's sampling port.
Breathing circuit sets for Hamilton ventilators may have cracks that prevent adequate fresh gas delivery, causing dangerous rebreathing of exhaled gases and potential organ dysfunction.
Draeger SafeStar 55 Plus breathing system filters are being recalled due to reports of slow CO2 curve increases when gas samples are taken from the filter's sampling port.
Osteotec Limited is recalling approximately 15,573 Osteotec Silicone Finger Implants due to potential foreign material contamination. The affected models are OSTF-3, OSTF-4, and OSTF-5.
Philips North America is recalling Achieva 3.0T MRI systems due to potential gradient coil component failures that could produce smoke or fire. The recall affects 460 units distributed worldwide.
Philips is recalling 294 SmartPath to dStream MRI systems due to potential component failures in the gradient coil that could produce smoke and fire. No injuries have been reported.
Philips is recalling 50 Evolution Upgrade 3.0T MRI systems worldwide due to potential fire and smoke from gradient coil component failures.
Philips is recalling 93 MRI systems with defective gradient coil components that may produce smoke or fire due to component failure.
LTS Therapy Systems is recalling the IontoPatch 80 iontophoresis patch because the nonwoven pads do not absorb the saline solution required for proper device operation. Approximately 63,936 units were distributed nationwide.
Philips Ingenia 1.5T MRI systems are recalled due to potential gradient coil component failures that may produce smoke or fire. The recall affects 2,279 units distributed worldwide.
Fresenius Kabi USA, LLC is recalling LVP Primary Administration Sets due to potential for external cassette leaks. The recall affects 35,925 units distributed nationwide.
The Inseego USB8 4G Dongle Kit is being recalled because its USB flash drive contains outdated software that could revert the Tempus Pro Monitor to a previous unsafe state, potentially causing loss of critical monitoring functions and delayed treatment.
Philips is recalling 690 Ingenia Ambition X MR systems worldwide due to potential gradient coil component failures that could produce smoke or fire. Verify your device's model and serial number against the FDA recall list.
MICROVENTION INC. is recalling LIFEPEARL Drug Elutable Microspheres because their actual diameter is smaller than specified. This may prevent proper targeted delivery and treatment.
Select batches of BostonSight PROSE contact lenses were manufactured with errors affecting optical properties and lens fit. Affected units have been identified by serial number.
Siemens recalls RAPIDPoint 500 wash/waste cartridges due to manufacturing errors that may cause inaccurate blood test results in clinical laboratories.
Remel, Inc. is recalling Blood/EMB Levine 100/PK culture media due to potential Listeria monocytogenes surface and subsurface contamination. The product was distributed nationwide across the US.