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.
Cordis recalled 70 units of MYNXGRIP vascular closure devices due to carton label errors affecting two lots. Carton boxes were labeled incorrectly, though individual device labels are correct.
Shiloh Farms recalled 534 cases of Bread for Life Organic 7 Grain due to labeling error: cholesterol and sodium daily values listed in grams instead of milligrams. Product content is accurate.
Baxter Healthcare recalls a marketing brochure for Peri-Guard Repair Patch because it contains inaccurate information that does not match the product's Instructions for Use.
Shirakawa Olympus is recalling instructions for the Model ENF-XP Rhino-Laryngofiberscope. Reusable cleaning brushes have been removed from the manual cleaning procedure; single-use brushes remain compatible.
Baxter Healthcare is recalling its Vascular Probe due to inaccurate marketing materials that do not align with the product's official Instructions for Use. Providers should reference only the official IFU and PI.
Vita 360, LLC is recalling SUPREX Plant Based Nutrition Carb & Sugar Block supplements (Lot #2633) because FDA testing found chromium content at only 16% of the declared amount.
A Baxter marketing brochure for FloSeal Hemostatic Matrix contains inaccurate content that does not match the product's official Instructions for Use and Prescribing Information.
Baxter Healthcare Corporation is recalling Baxter FloSeal Hemostatic Matrix RECOTHROM products because the marketing brochure contains inaccurate information that does not align with the product's official Instructions for Use and Prescribing Information.
Shirakawa Olympus has updated cleaning instructions for the EVIS EXERA III bronchovideoscope. Reusable brushes are no longer approved for manual cleaning; single-use brushes remain compatible.
Baxter Healthcare recalls Peri-Guard Repair Patch due to cardiovascular surgery marketing brochure containing inaccurate content that does not align with the product's Instructions for Use.
Garden Spot Foods recalls Shiloh Farms Organic Salt Free 7 Grain Bread due to incorrect units on the nutrition label. Daily cholesterol and sodium values are listed in grams instead of milligrams, though the product content itself is accurate.
Shiloh Farms Organic 7 Grain Bread mistakenly displays cholesterol and sodium values in grams instead of milligrams on its nutrition label. The actual product content is accurate and safe.
Busse Hospital Disposables is recalling tracheostomy care kits due to failed sterility assurance. The affected product cannot guarantee required sterility levels and poses risks of infection and sepsis.
ROi CPS LLC is recalling Regard Dressing change kits (Item 800026006) due to a defective irrigation solution component. Approximately 1,830 units distributed in Louisiana are affected.
Busse Hospital Disposables is recalling tracheostomy care kits containing Nurse Assist Sterile Normal Saline because the required sterility assurance level cannot be guaranteed. Contaminated products could cause serious infections including bloodstream, respiratory, and urinary tract infections, or sepsis.
Samsung Bean Sprout is recalling Sung Soy Bean Sprouts (1lb packages) distributed to Virginia due to Listeria monocytogenes contamination. Products have a sell-by date of 12/14/23.
The Omnipod 5 app bolus calculator may fail to record a decimal point if entered first when adjusting a dose, potentially causing insulin over-delivery. Users should verify dose values on both the calculator and confirmation screens before administering insulin.
Busse Hospital Disposables recalls sterile dressing change trays due to inability to guarantee required sterility assurance level. The defect could lead to serious infections including blood stream, urinary tract, or respiratory infections.
Philips recalled Trilogy Evo respiratory devices for missing contraindications in labeling. Devices lack warnings against use in pediatric patients under 10 kg and certain therapy modes, risking barotrauma and respiratory complications.
Merit Medical Systems is recalling 717 units of Merit Maestro Microcatheters because their sterility cannot be guaranteed. Non-sterile devices could introduce infection when used in medical procedures.
Spring Valley Biotin & Collagen Liquid is being recalled due to potential mold contamination. Approximately 24,324 units were distributed nationwide; consumers should stop using affected products.
Beaver Visitec International is recalling one lot of surgical knives where the blade is oriented incorrectly—bevel down instead of the required 55-degree bevel up. This defect could compromise surgical precision during use.
Natus Medical is recalling 3,336 units of the EDS 3 CSF External Drainage System nationwide because incomplete bioburden testing cannot guarantee sterility. No illnesses have been reported, but non-sterile devices pose infection risk.
One lot of Xstar Kojo Safety Slit Knife contains inverted blades (bevel down instead of bevel up). The 2160 affected units from lot 6049877 were distributed internationally, including to Japan.
Merit Medical Systems is recalling Merit Pursue Microcatheter devices distributed worldwide because sterility cannot be guaranteed. Patients should contact their healthcare provider.