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.
Vista MAX dietary supplement contains undeclared Yellow #5 dye. Consumers allergic to or sensitive to Yellow #5 should not consume the product.
Siemens Medical Solutions is recalling ARTIS icono ceiling Model 11328100 because screws in the Display ceiling suspension (DCS Fix XL) that hold the monitor may gradually loosen over time, potentially causing the monitor to detach.
Bard Access Systems is recalling Provena Midline Catheters because lidocaine ampoules used in manufacturing were produced under deficient manufacturing practices by a supplier.
Medela ENFit ExSet Strl 60 enteral extension sets may contain incorrect connectors that do not attach or misconnect to ENFit connections, potentially delaying delivery of nutritional fluids or medication.
Blaine Labs Inc is recalling vite20 Antifungal Cream (10% Undecylenic Acid) because the manufacturer discontinued required stability testing for products still on the market within expiration dates.
Medline Industries is recalling Convenience Kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules due to quality issues identified during an FDA manufacturing inspection of the supplier's facility.
Zimmer Surgical Inc is recalling A.T.S. 4000 TS Tourniquet Systems Dual Hose with CPC Connectors due to a potential sterility breach in the sealing area of the sterile pouch. If used, the issue may result in moderate localized infection.
Zimmer Surgical Inc is recalling A.T.S 4000 TS Tourniquet Systems Single Hose units due to a potential sterility breach in the sealing area of the sterile pouch. If used, the compromised sterility may result in moderate localized infection.
Boston Scientific is recalling the CRE Pro Wireguided 15-18mm 240cm device due to a potential sterile breach of the product pouches. The breach may compromise device sterility.
Accord Healthcare is recalling Levothyroxine Sodium Tablets 300 mcg (90-tablet bottles) nationwide due to subpotency. The affected lot is D2401522 with expiration date 06/2026.
Boston Scientific Corporation is recalling the CRE Wireguided 15-18mm 240cm device due to a potential sterile breach in the packaging pouches. The affected devices were distributed worldwide.
Blaine Labs Inc is recalling Revitaderm Wound Care (Benzalkonium Chloride 0.1%) topical antiseptic gel due to current good manufacturing practice (CGMP) deviations. The product was manufactured in the same facility under the same conditions as a product found to be contaminated.
Bard Access Systems is recalling Power-Trialysis Slim-Cath short-term dialysis catheters due to lidocaine ampoules manufactured under deficient manufacturing practices. The recall affects multiple product models distributed nationwide and internationally.
Wells Enterprises is recalling Blue Ribbon Classics French Vanilla ice cream in 1-gallon pails due to elevated coliforms. The affected product was distributed to one customer in Kenosha, Wisconsin.
Bard Access Systems is recalling PowerMidline Catheters due to lidocaine ampoules being manufactured under deficient manufacturing practices. The catheters are used for short-term peripheral intravenous access and have been distributed nationwide and internationally.
Boston Scientific Corporation is recalling CRE Wireguided 8-10mm 240cm devices worldwide due to potential sterile breaches in the packaging pouches that could compromise device sterility.
Medline Convenience Kits containing Huons Lidocaine HCL Injection USP 1% ampules are being recalled due to quality issues identified during an FDA manufacturing inspection. Affected kits have been distributed nationwide.
Covidien LLC is recalling Shiley Disposable Decannulation Plug devices because the product labeling incorrectly indicates the product does not contain DEHP, when in fact the product contains 30 to 35% DEHP.
Laborie Medical Technologies is recalling Solar GI System (Water Perfusion) units worldwide because moisture may accumulate in internal tubing and filters under extended use, potentially affecting airflow and pressure measurement performance.
Bard Access Systems is recalling Poly Midline Catheters because lidocaine ampoules were manufactured under deficient manufacturing practices.
Medline Industries is recalling three convenience kits containing Huons Lidocaine HCL Injection USP 1% due to quality issues identified during an FDA manufacturing inspection of Huons' facility.
Bard Access Systems is recalling Power-Trialysis Short-Term Dialysis Catheters with triple-lumen design due to lidocaine ampoules manufactured under deficient manufacturing practices. The recall affects approximately 8,795 units distributed nationwide and internationally.
Medline Industries is recalling convenience kits containing Huons Lidocaine HCL Injection USP 1% ampules due to quality issues identified during an FDA manufacturing inspection of the drug maker's site.
Bard Access Systems is recalling PowerPICC Provena Catheters due to lidocaine ampoules manufactured under deficient manufacturing practices. The recall affects 29,490 units distributed nationwide and in Belgium.
Medline Industries is recalling 432 L&D Continuous Epidural Tray kits nationwide due to quality issues identified with the included Lidocaine ampules during an FDA manufacturing inspection.