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
Philips has identified that some Allura Xper FD20 biplane systems may have uninstalled or undocumented drip trays beneath the cooling unit, creating risk for coolant to contact electrical components and cause system shutdown.
Medline has recalled 633 kits containing B. Braun IV Administration Sets and Pump Administration Sets due to customer complaints that check valve components may become stuck in open or closed positions.
Medline is recalling IV administration kits containing B. Braun administration sets because check valve components may become stuck in open or closed positions. Ninety-six units were distributed nationwide.
Philips is recalling 12 Allura Xper FD10F angiography systems worldwide because the cooling system's drip tray may not be installed. Without the tray, coolant could contact electrical components and cause short-circuits leading to system shutdown.
Philips recalls 93 Allura Xper FD10 imaging systems due to missing or undocumented drip tray installations, which could allow coolant to contact electrical components and cause system shutdown.
Mobius Imaging is recalling 101 AIRO CT X-ray system pendant components lacking the required 'Safe Hand Position Warning' label, which informs operators of proper positioning during use.
Medtronic recalls versions 2.0.2465 and 2.0.2683 of the Vanta Clinician Programmer Application. The software does not function as intended, creating potential for prolonged or postponed surgical procedures.
Philips Azurion X-ray imaging systems may experience nine software issues causing loss of X-ray imaging, system restarts, and diagnostic tool misalignment. 990 units distributed worldwide are affected.
Medline has recalled multiple kits containing B. Braun IV administration sets because the check valve components may become stuck in open or closed positions. The recall affects 3,045 units distributed nationwide.
The MAVERICK Measurement Module Spectrometer has a cable defect that can cause elevated laser output (approximately 1,600 mW) or unintended laser firing during measurement cycles. No injuries have been reported.
Medline is recalling certain pre-op kits due to check valve defects in IV and pump administration sets. The valves may become stuck in either position, potentially impairing medication delivery.
ICU Medical is recalling certain Pulsator Arterial Blood Sampling Kits due to cracks in the syringe collar that may cause blood leakage or delayed delivery during arterial sampling.
Certain Philips Allura Xper FD20/10 imaging systems may lack a required drip tray beneath the cooling unit. If missing, coolant could contact electrical components and cause system shutdown.
GE HealthCare is recalling certain nuclear medicine imaging systems with potentially compromised detector mounting mechanisms that could fail during transport. No injuries have been reported, but detector falls could cause serious harm.
Mobius Imaging is recalling 26 AIRO CT pendant upgrade components lacking a required 'Safe Hand Position Warning' label. The missing label could prevent users from recognizing safe hand positioning during equipment operation.
Canon Medical's VANTAGE TITAN 3T MRI systems may develop ice in the magnet vent system, which could trap helium gas and cause vessel rupture if an emergency discharge occurs, releasing pressurized helium into the scanning room.
Intuitive Surgical is recalling da Vinci SP Access Port Kits because the system tray may develop cracks that could breach sterility during surgical use.
Medline kits containing B. Braun IV Administration Sets are recalled because check valve components may become stuck, potentially affecting medication delivery. Lot Number 25HBQ850 is affected.
Medicrea is recalling IB3D PL Instruments Sets because the orthopedic rotation tool handle may detach from the shaft, preventing implant rotation during surgery. The Class II recall affects 44 units distributed across nine U.S. states.
Boston Scientific is recalling certain batches of Coyote Over-the-Wire Balloon Dilation Catheters that may not properly inflate or deflate during use in peripheral vessels.
The Philips Allura Xper FD20 fluoroscopy system may lack a drip tray beneath its cooling unit, potentially allowing coolant to contact electrical components and cause device shutdown. The recall affects 143 units worldwide.
Philips is recalling the Allura Xper FD10 because the drip tray beneath the cooling unit may not be installed in some units, potentially allowing coolant to contact electrical components and cause system shutdown.
Medline is recalling 12,584 surgical procedure kits containing Stryker Strykeflow 2 irrigators due to a design defect that causes irrigation solution to leak and emit vaporized saline during use.
PALACOS R+G pro bone cement is recalled due to defects that prevent ampoule breakage, blocking cement dough formation and making the product unusable.
Fresenius Kabi is emphasizing instructions for large volume parenteral (LVP) programming duration in the Ivenix Infusion System software. 30 units were distributed nationwide.