Safety recalls that rarely make the news, straight from the official U.S. agency records (FDA, USDA, CPSC, NHTSA). Every listing links to its official notice. We only copy what the record says.
Checked Nov 2, 11:30 PM ET · refreshed about every 2.5 hours · RSS · Get recall alerts
FDA drug and medical device recalls.
State filter: shows recalls whose official distribution lists that state, plus nationwide ones. CPSC and NHTSA recalls apply nationwide.
514 recalls
Medicines & devicesClass II
Firm has identified mismatches between the outbreak strain and the reference strain used in the development of its qualitative, multiplexed, nucleic acid-based in vitro diagnostic panel test.
· FDA · Nationwide
Medicines & devicesClass III
Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
· FDA · TN
Medicines & devicesClass II
Bone fixation staple requires a new 510(k); the performance characteristics of this device have not been adequately established.
· FDA · Nationwide
Medicines & devicesClass I
Retroactive reporting for 2024 rework conducted at the 3B/React Health warehouse
· FDA · FL
Medicines & devicesClass II
a software defect in which the Parameter Package (PP) import logic overwrites all predefined calculated test rules, including those previously modified by the user, upon import of a new Parameter Package version. As a re
· FDA · Nationwide
Medicines & devicesClass II
Lack of Assurance of Sterility
· FDA · Nationwide
Medicines & devicesClass II
Failed Impurities/Degradation Specifications
· FDA · Nationwide
Medicines & devicesClass I
Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which are contaminated with Aspergillus penicillioides
· FDA · Nationwide
Medicines & devicesClass II
Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which lacks sterility assurance due to to wrinkles in the paper lidding which may breach the seal area.
· FDA · Nationwide
Medicines & devicesClass II
Complaints of blue-green discoloration in product
· FDA · Nationwide
Medicines & devicesClass II
Hollister has identified that select lots of the catheters identified in the above table may exhibit a protrusion caused by a manufacturing defect which might lead to genitourinary trauma or bleeding.
· FDA · Nationwide
Medicines & devicesClass II
Suture anchor may contain incorrect patient implant card which may result in incorrect device identification and traceability.
· FDA · Nationwide
Medicines & devicesClass II
Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.
· FDA · Nationwide
Medicines & devicesClass II
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
· FDA · Nationwide
Medicines & devicesClass II
Subpotent Drug
· FDA · Nationwide
Medicines & devicesClass II
Presence of Precipitate: medication was crystallizing and particles floating in the bottle
· FDA · Nationwide
Medicines & devicesKids & BabiesClass II
Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discoloration, melting, smoke, burning odor, or other signs of localiz
· FDA · Nationwide
Medicines & devicesClass II
Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated quinidine measurements, creating risk of sub-optimal patient treatment, includi
· FDA · Nationwide
Medicines & devicesClass II
Overheating of the 115V CPU board may cause the device to shut down.
· FDA · Nationwide
Medicines & devicesClass II
Due to an internal sensor issue, image displayed with eyepiece may appear tilted relative to the eyepiece housing
· FDA · 20 states
Medicines & devicesClass II
Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result in insulin over- or under-delivery, potentially causing hypog
· FDA
Medicines & devicesClass II
Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.
· FDA · Nationwide
Medicines & devicesClass II
There may be a mismatch between the implant contained inside the packaging and the information described on the outer carton label. If the the incorrect implant is installed, the issue could cause bone compression or dif
· FDA · Nationwide
Medicines & devicesClass II
There is a potential for vaginal speculums to contain a burr on the proximal plastic blade, which may introduce a sharp edge in the contact regions for both the patient and the healthcare provider.
· FDA · Nationwide
Medicines & devicesClass II
Kits contain a potentially contaminated component which were recalled by the manufacturer
· FDA · Nationwide
Medicines & devicesClass II
Component labeling discrepancy
· FDA · Nationwide
Medicines & devicesClass II
The kit component was subjected to EO sterilization, contrary to the manufacturer recommendation, which may have led to the component leaking in a kit.
· FDA · Nationwide
Medicines & devicesClass III
Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility.
· FDA · Nationwide
Medicines & devicesClass II
A software vulnerability may allow unauthorized persons to gain privileged access to the device, which could result in loss of patient monitoring, missed patient alarms, and/or access to Protected Health Information (PHI
· FDA · Nationwide
Medicines & devicesClass II
Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator
· FDA · Nationwide
Recall data comes from official U.S. government sources: openFDA (food, drugs, devices), USDA FSIS (meat, poultry, egg products), CPSC (consumer and children’s products) and NHTSA (vehicles, equipment, car seats). openFDA notes its data should not be relied on for medical decisions. Always confirm with the official notice. Check your vehicle by VIN at nhtsa.gov/recalls.