Agency
The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.
The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.
FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.
Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.
Ampicillin for Injection (2g per vial) is being recalled nationwide because the manufacturer cannot assure the product meets sterility standards. All 45,160 affected vials in circulation are included.
Boston Scientific recalls 1,300 WATCHDOG Hemostasis Valve Kits due to insertion tool occlusion that prevents guidewire passage. Affected units were distributed worldwide.
Apollo Care's VANComycin 750mg injectable lacks assurance of sterility. The 491 bags distributed in Missouri are being recalled due to potential contamination risk.
The FDA is recalling 11,555 bottles of Ampicillin and Sulbactam for Injection due to lack of assurance of sterility. The nationwide recall affects all lots within expiry.
Astral SteriTech is recalling 101,550 vials of Cefepime for Injection nationwide because sterility assurance cannot be confirmed.
Smiths Medical ASD recalled 14,941 DuraLife silicone extension tubes worldwide due to incomplete sterilization instructions that could compromise patient safety.
Boston Scientific's Watchdog Accessory Kit is being recalled because the insertion tool component can become occluded, preventing guidewire passage. The recall affects 10,833 units distributed worldwide.
Apollo Care, LLC recalled 308 bags of fentanyl and ropivacaine injectable solution due to lack of assurance of sterility. The affected product was distributed in Missouri only.
The FDA is recalling Ampicillin and Sulbactam for Injection due to lack of assurance of sterility. The medication was distributed nationwide within the United States.
Piramal Critical Care is recalling Piperacillin and Tazobactam for Injection, USP, 2.25 grams per vial, due to lack of sterility assurance. The nationwide recall affects approximately 112,640 vials.
Big Bold Health is recalling Microbiome Rejuvenate dietary supplement bottles due to glass fragment contamination. The recall affects 1,087 bottles distributed nationwide and internationally.
Astral SteriTech is recalling 51,280 vials of Cefepime for Injection nationwide because the manufacturer cannot assure that all vials meet sterility requirements. The product is distributed across the United States.
YelloPort Elite optical trocars (3,405 units) are recalled because sterility assurance cannot be guaranteed. The surgical instruments were distributed in Massachusetts.
Apollo Care's fentanyl 50 mcg/mL injectable syringes are recalled due to lack of assurance of sterility. The 790-syringe batch distributed in Missouri may pose contamination risks if administered.
Apollo Care, LLC is recalling VANComycin 1 g added to 250 mL of 0.9% Sodium Chloride Injection due to lack of assurance of sterility. The recall affects 1,622 bags distributed in Missouri.
Beckman Coulter is recalling Bicarbonate reagent (REF: OSR6137) worldwide due to potential decreases in calibration optical densities that could cause calibration and quality control failures in clinical laboratory tests.
Astral SteriTech is recalling Ampicillin and Sulbactam for Injection due to inability to assure product sterility. Approximately 357,550 vials distributed nationwide; no illnesses have been reported.
Astral SteriTech is recalling 17,350 vials of Ampicillin for Injection nationwide because the manufacturer cannot assure the product's sterility. Healthcare providers and patients should consult their healthcare provider about exposure.
Ceftriaxone for Injection is being recalled due to lack of assurance of sterility. The recall affects 65,950 vials distributed nationwide in the United States.
Astral SteriTech is recalling approximately 89,690 vials of Ampicillin for Injection due to lack of assurance of sterility. The product was distributed nationwide.
Beckman Coulter is recalling UA WIN 10 diagnostic kits because an optional software flag for detecting sample carryover was enabled but not displayed, preventing proper investigation of potential test contamination.
Apollo Care, LLC is recalling 1,113 bags of Vancomycin 1.25g injection in 250 mL of 0.9% Sodium Chloride solution due to lack of assurance of sterility. The recall affects product distributed in Missouri.
Smiths Medical is recalling DuraLife Swivel Elbow breathing circuit devices due to inadequate sterilization instructions. The device instructions lack cleaning methods, autoclave cycle duration, and reuse specifications.
Ampicillin and Sulbactam for Injection is being recalled nationwide because the manufacturer cannot assure sterility of 591,160 vials distributed throughout the United States.
Apollo Care, LLC is recalling a VANComycin injectable medication due to lack of assurance of sterility. The affected lot was distributed in Missouri only.