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.
Steris Corporation is recalling Dual Articulating Headrests that may fail to lock in position during patient procedures, potentially causing patient injury. Affected units were manufactured between August and October 2023.
Beckman Coulter DxI 9000 immunoassay analyzers may produce erroneous lab results due to software bugs affecting unit conversion and result calculation. Affected devices use software version 1.16 or earlier; 128 devices worldwide are impacted.
Maquet Medical Systems is recalling 1,090 RotaFlow centrifugal pumps used in heart surgery due to seal defects that could compromise sterile barriers and expose patients to infection.
Philips is recalling Ingenia Elition X patient transportation systems due to magnetic wheels that may be attracted to MRI systems, posing a patient safety risk if used in MRI environments.
BD BBL Sensi Disc Moxifloxacin test discs are recalled due to possible failures in antibiotic susceptibility testing accuracy. Test failures could lead to delayed diagnosis or inappropriate antibiotic selection.
Becton Dickinson is recalling 2,363,168 units of BD BBL Sensi Disc Levofloxacin testing discs (Catalog No. 231705, 231706) due to potential accuracy and quality control failures in antibiotic susceptibility testing that could lead to delayed diagnosis or inappropriate antibiotic selection.
Becton Dickinson is recalling 2.3 million antibiotic susceptibility testing discs due to accuracy and quality control failures. The discs may cause delayed or incorrect test results, potentially leading to inappropriate antibiotic selection.
Greco Sidari is recalling Joey's Roast Beef Sliced Premium because it was not held at appropriate temperatures, potentially allowing pathogenic growth. The product was distributed in Ohio, New York, and Pennsylvania from November 2023 to January 2024.
Greco Sidari is recalling Conway Caesar Classic Dressing in 4-gallon cases due to improper temperature storage that could support pathogen growth. No illnesses have been reported. The recall affects 1,375 cases distributed to Ohio, New York, and Pennsylvania.
Greco Sidari is recalling 1,375 cases of Galbani Smoked Provalone distributed in Ohio, New York, and Pennsylvania due to improper storage temperatures that could have allowed pathogenic growth.
BALT USA is recalling Prestige Coil Systems due to corrosion of the delivery pusher. Solder flux residue can cause the discolored hypotube to break off and enter patient blood vessels as foreign emboli.
BioFire Diagnostics is recalling FilmArray Pneumonia Panel Plus diagnostic test kits due to a potential for false positive results. These inaccurate results could lead to incorrect pneumonia diagnoses.
FLEXSelect 5/16" Amber Latex Elastics were labeled as non-latex, creating allergy risk for latex-sensitive patients. Patients with latex allergies should immediately stop using the product.
OMEZA LLC is recalling Omeza Skin Protectant Gel due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects 1,210 vials distributed nationwide.
Greco Sidari is recalling Norpaco garlic-stuffed olives because they were not held at proper temperatures, which could allow spoilage and pathogenic growth. The recall covers 1,375 cases distributed in Ohio, New York, and Pennsylvania.
Greco Sidari is recalling Norpaco Sweetie Pepper Goat Cheese (1,375 cases, 1/5# units) distributed in Ohio, New York, and Pennsylvania. The cheese was not held at appropriate temperatures, which could support pathogen growth.
Greco Sidari is recalling Bellissimo Mascarpone (1375 cases) distributed to OH, NY, and PA due to improper temperature storage that could allow spoilage and pathogenic growth.
Becton Dickinson is recalling BD BBL Sensi Disc Azithromycin test discs due to potential accuracy and quality control failures that may delay diagnosis or result in inappropriate antibiotic selection.
Becton Dickinson is recalling BD BBL Sensi Disc Meropenem antibiotic susceptibility testing discs due to accuracy and quality control failures that may cause delayed or incorrect diagnostic results.
Greco Sidari is recalling GRANDE fresh bocconcini mozzarella because the product was not held at appropriate temperatures during storage. The temperature failure could allow spoilage and pathogen growth.
BD BBL Sensi Disc Rifampin antibiotic susceptibility test discs are being recalled due to potential accuracy and quality control failures. These discs are distributed domestically nationwide and internationally.
Becton Dickinson is recalling BD BBL Sensi Disc Ampicillin antibiotic susceptibility testing discs due to accuracy and quality control failures that may cause delayed diagnosis or inappropriate antibiotic selection.
Globus Medical is recalling Cranial Drill 6.00mm units due to potential packaging breaches that may render the sterile product non-sterile, and discoloration near the drill tip.
Greco Sidari is recalling Grande Prima Dolce Ricotta due to improper temperature storage that could allow pathogen growth. The recall affects 1,375 cases distributed to Ohio, New York, and Pennsylvania.
Bel Gioioso cheese was not held at appropriate temperatures during distribution, potentially allowing spoilage and pathogen growth. Consumers should not consume affected product.