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.
GRANDE SOPRAFFINA ricotta cheese was not held at appropriate temperatures, potentially supporting pathogen growth. Affected lots distributed to OH, NY, and PA from November 26, 2023 to January 5, 2024.
Philips Spectral CT 7500 imaging devices contain a software defect that can incorrectly label captured images, potentially causing misdiagnosis and incorrect treatment. Affected units total 33 in the US and 177 worldwide.
Alfred Louie Inc is recalling Pan Fry and Deep Fry Fresh Noodles due to undeclared wheat allergen from enriched flour sub-ingredients. 550 cases distributed in California are affected.
Brasseler USA recalls 440 dental burs due to right angle latch specification failure that prevents proper latching in dental handpieces.
Getinge's Flow-i C40 Anesthesia System (model 6677400) contains a potential cybersecurity vulnerability allowing remote login attacks that could result in denial of service, system tampering, or remote code execution.
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.
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.
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.
BD BBL Sensi Disc Chloramphenicol test discs may have accuracy and quality control failures during antibiotic susceptibility testing. This could cause delayed results or inappropriate antibiotic selections.
BD BBL Sensi Disc Cefixime testing discs are recalled due to potential accuracy and quality control failures that may result in delayed diagnosis or inappropriate antibiotic selection in clinical laboratories.
Greco Sidari fresh mozzarella cheese sold in Ohio, New York, and Pennsylvania was not held at appropriate temperatures, which could affect spoilage and potentially support pathogen growth. Consumers should discard affected products or return them to the retailer.
Becton Dickinson recalls BD BBL Sensi Disc Clarithromycin-15 ug susceptibility testing discs due to accuracy and reproducibility failures that may produce inaccurate test results in clinical laboratories.
Ito-Shoten Seasoned Mushroom is recalled due to lack of filed thermal processing procedures. The product was distributed to CA, NJ, IL, TX, and HI.
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.
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.
BD BBL Sensi Disc Ertapenem test discs are being recalled due to reproducibility and accuracy failures that may cause diagnostic errors, 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.
Amneal Pharmaceuticals is recalling Phenoxybenzamine Hydrochloride Capsules, 10mg, due to an unknown impurity. The recall affects 858 bottles distributed nationwide.
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.
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.
Greco Sidari recalled Norpaco Gorgonzola Stuff Olive cheese cases distributed in Ohio, New York, and Pennsylvania due to improper temperature storage. The temperature failure could have allowed spoilage and potential pathogen growth.
Wegmans is recalling 24ct Petite Pastry Tray croissants due to undeclared soy lecithin. The affected products were distributed across nine states from New York to North Carolina.
BD BBL Sensi Disc Doripenem susceptibility testing discs may fail to accurately test antibiotic resistance in H. influenzae, potentially leading to incorrect antibiotic selection and delayed diagnosis. The FDA has recalled 2,363,168 units.
GE Medical Systems is recalling 180 Senographe Pristina mammography X-ray systems because the audible signal indicating the end of X-ray exposure intermittently fails to sound, violating FDA safety requirements.
Siemens is recalling 7,075 units of its Total Immunoglobulin M diagnostic reagent due to potential negative bias in quality control and patient sample results. This could affect the accuracy of test results.