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
AGFA Healthcare is recalling the DR 800 digital radiography system because it can exceed safe radiation dose limits if the frame rate is increased while the ABS safety feature is disabled. Nationwide distribution affects 35 units.
Cook Incorporated is recalling 23 units of Rosch-Uchida Transjugular Liver Access Sets due to manufacturing specification defects. Devices may have been cut to incorrect lengths, improperly trimmed, or inadequately inspected.
Zimmer, Inc. is recalling Affixus Antegrade Femoral Nails due to undersized distal diameters that could cause implant fatigue fracture. The defect may lead to non-union, malunion, or tissue damage requiring surgical intervention.
Zimmer Affixus Antegrade Femoral Nails may develop undersized defects leading to implant fatigue fracture, potentially causing pain, tissue damage, and the need for revision surgery. The FDA Class II recall affects 11 units distributed nationwide.
Diasol, Inc. is recalling a dialysis concentrate product because safety and efficacy cannot be assured. The recall affects 74,400 gallons distributed in six US states.
Zimmer's Affixus femoral nails may have undersized distal diameters risking implant fracture. Affected patients may experience pain, failed bone healing, or require additional surgery.
Zimmer, Inc. is recalling 22 Affixus Antegrade Femoral Nailing systems due to an undersized distal diameter defect that could cause implant fatigue fracture. Potential complications include tissue damage and surgical intervention may be required.
Cook Incorporated is recalling 15 units of Ring Transjugular Intrahepatic Access Sets due to manufacturing defects. Affected devices may have been cut to incorrect length, improperly trimmed, and inadequately inspected.
Beckman Coulter Bicarbonate reagent may produce falsely high test results due to interference with lactate dehydrogenase (LDH) in the sample. Approximately 36,981 units have been distributed worldwide, with 35,320 in the United States.
Diasol Inc. is recalling a dialysis concentrate product because safety and efficacy cannot be assured. The product is distributed nationwide in Missouri, California, Arizona, Texas, Illinois, and Massachusetts.
Cook Medical is recalling Flexor Check-Flo Introducers and Sets due to manufacturing defects. Affected products may have been cut to incorrect lengths, improperly trimmed, or inadequately inspected.
Zimmer, Inc. is recalling Affixus Antegrade Femoral Nailing System implants with undersized distal diameter that could fracture during use, potentially requiring surgical intervention.
Zimmer is recalling Affixus Antegrade Femoral Nails due to undersized distal diameter that could cause implant fatigue fracture. Affected patients may experience pain, non-union, tissue damage, and may require surgical intervention.
Zimmer is recalling limited units of Affixus Antegrade Femoral Nails due to undersized distal diameter that may cause implant fracture. Potential complications include non-union, malunion, and tissue damage requiring surgical intervention.
Diasol, Inc. is recalling 186,000 containers of dialysis concentrate because the manufacturer cannot assure product safety and efficacy. The recall affects dialysis centers in six states.
LifeShield Drug Library Management software limits drug concentration precision to one decimal place instead of three, potentially forcing users to deviate from manufacturer recommendations and risking medication delivery errors.
Zimmer is recalling 22 Affixus Antegrade Femoral Nails due to undersized distal diameters that may cause implant fracture and complications including pain and tissue damage requiring surgery.
Microbiologics Inc is recalling KWIK-STIK 6-Pack Campylobacter jejuni reference material because affected units may fail to recover the target organism needed for quality control testing.
A firmware update to BD Pyxis automated medication dispensing cabinets causes drawer failure, potentially delaying access to critical hospital medications.
Zimmer is recalling Affixus Antegrade Femoral Nails (Model 815509420) due to undersized shaft diameter that may cause implant fracture, potentially requiring additional surgery.
Diasol, Inc. is recalling its Diasol liquid concentrate for bicarbonate dialysis because the safety and efficacy of the product cannot be assured. The recall affects 7,200 gallons distributed nationwide.
Zimmer is recalling 24 units of Affixus Antegrade Femoral Nails due to a manufacturing defect that could cause implant fracture. Patients who received these units should contact their healthcare provider.
Microbiologics Inc recalled KWIK-STIK 2-Pack quality control product because affected units may fail to recover the target Campylobacter jejuni microorganism used in laboratory procedures.
Microbiologics is recalling certain LYFO Disk products containing Campylobacter jejuni because the organisms may not be recoverable, potentially affecting laboratory quality control procedures.
GE Healthcare is recalling Carestation anesthesia systems that may shut down unexpectedly during power loss, potentially disrupting mechanical ventilation and volatile agent delivery. This FDA Class I recall affects 888 units distributed worldwide.