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
Vision RT is recalling AlignRT InBore systems due to missing laser information in the Instructions for Use. The omission violates FDA regulatory requirements for laser safety documentation.
Beckman Coulter UniCel Dxl 800 analyzers may fail to restart following standard shutdown due to a communication issue. When this occurs, units cannot process patient samples, resulting in delayed test results.
Abiomed is recalling six Impella 5.5 with SmartAssist S2 cardiac assist devices distributed to Australia and Taiwan because they were packaged in an incorrect outer box carton.
The BVI Leos Laser and Endoscopy System is being recalled because ferrites were omitted from the USB cable assembly, potentially causing electromagnetic interference. Five units were distributed in Florida, Michigan, Oklahoma, Texas, and Wisconsin.
Philips is recalling EPIQ Ultrasound Systems that may experience unexpected automatic reboots, potentially causing transducer damage. Users should contact Philips for resolution.
SHENZHEN ATOMSTACK TECHNOLOGIES is recalling material processing laser products that lack a required remote interlock connector mandated by federal safety regulations. The missing component is required under 21 CFR 1040.10(f)(3).
Sheathes3D ultrasound probe covers may have product defects allowing contamination during use, creating infection risk. Affected devices distributed nationwide in Washington state.
Mastisol Liquid Adhesive vials with lot code 24161B are being recalled because the butyrate tube cracks during actuation, rendering the product unusable. Units distributed in the US and UK.
Vortex Surgical is recalling 221 units of its 25ga Illuminated Flex-Tip Laser Probe (Lot 2509040) because some units do not insert smoothly through a 25ga cannula.
Draeger is recalling 431 Vapor 2000 anesthetic vaporizers with a component not manufactured to specification and containing impurities. The devices were distributed worldwide. No illnesses or injuries have been reported.
A software issue in the Restore Clinician Programmer Application can prevent therapy from resuming, causing pain recurrence. Affected devices worldwide may require surgical replacement.
Draeger is recalling 188 Vapor 3000 anesthetic vaporizers worldwide because a component was manufactured outside specification with impurities that could affect anesthetic delivery.
Alcon Custom Pak sterile ophthalmic surgical procedure packs may have incomplete seals compromising sterility. Affected units distributed in California, North Dakota, and Utah.
Zimmer is recalling Affixus Antegrade Femoral Nails due to undersized distal diameter that could cause implant fatigue fracture and require surgery.
ICU Medical's LifeShield Drug Library Management v2.2.1 has a nonfunctional Change Summary review feature for certain migrated customers. Users must use alternate methods to review library changes, or risk over-delivery, under-delivery, or setup delays.
The Stryker CranialMask Tracker may display a software error during surgery that prevents device activation. This surgical tracking device is used in cranial procedures.
Zimmer is recalling Affixus Antegrade Femoral Nails due to undersized distal diameter that could cause implant fracture, potentially leading to tissue damage requiring surgery. The recall affects 23 units distributed nationwide.
Diasol, Inc. is recalling its bicarbonate dialysis acid concentrate (Lot PHV08042) because the safety and efficacy of the product cannot be assured. Approximately 2,200 gallons were distributed nationwide.
Diasol, Inc is recalling its bicarbonate dialysis acid concentrate (4,400 gallons) distributed nationwide due to safety and efficacy assurance issues.
Intuitive Surgical is recalling 144 da Vinci 5 Surgeon Console Column Motor Connectors due to potential connector failure that may lock ergonomic controls, preventing adjustment of headrest, armrest, viewer, and pedal tray until the device is restarted.
Zimmer is recalling Affixus Antegrade Femoral Nails with undersized distal diameter risking implant fatigue fracture. Affected implants distributed across 14 US states could cause adverse tissue reactions, non-union, or require surgical intervention.
Zimmer is recalling 11 Affixus Antegrade Femoral Nails due to potential undersized distal diameters that may cause implant fatigue fracture. Complications can include adverse tissue reaction, pain, non-union, or tissue damage requiring surgery.
Zimmer is recalling Affixus Antegrade Femoral Nailing System implants that may have undersized distal diameter, creating risk of implant fatigue fracture and potential need for surgical intervention.
Zimmer is recalling specific lots of Affixus Antegrade Femoral Nails due to undersized distal diameter that could cause implant fracture. Affected patients may experience tissue damage or adverse reactions requiring additional surgery.
Zimmer, Inc. is recalling specific lots of Affixus Antegrade Femoral Nails due to potential undersized distal diameter that could cause implant fatigue fracture. No injuries have been reported.