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.
Wegmans has recalled chocolate croissants containing undeclared soy lecithin due to allergen risk. The recall affects 10,338 units distributed across nine states.
BD BBL Sensi Disc Aztreonam test discs are recalled due to possible accuracy and quality control failures in antibiotic susceptibility testing. Failures could result in delayed diagnoses and inappropriate antibiotic selection.
Medtronic is recalling Guardian 4 Glucose Sensors due to manufacturing defects in the glucose oxidase layer. Defects may cause sensors to malfunction or provide inaccurate readings, potentially affecting insulin dosing.
Greco Sidari is recalling Auricchio Crema al Reggiano cheese because the product was not held at appropriate temperatures, which could allow spoilage and pathogen growth. The recall affects 1,375 cases distributed to Ohio, New York, and Pennsylvania.
Ivoclar Vivadent is recalling dental amalgam powder that may not triturate properly, affecting restoration strength and working characteristics. Dentists should stop using the recalled lot and contact the manufacturer.
Becton Dickinson recalled BD BBL Sensi Disc Augmentin testing discs due to potential accuracy and quality control failures in antibiotic susceptibility testing. Failures may lead to delayed diagnosis or inappropriate antibiotic selection.
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.
BD BBL Sensi Disc Cefotaxime susceptibility testing discs may produce inaccurate results for H. influenzae, potentially leading to delayed diagnosis and inappropriate antibiotic selection. The FDA has recalled 2,363,168 units distributed domestically and internationally.
The Flow-c Anesthesia System model 6887700 has a cybersecurity vulnerability allowing potential denial of service, tampering, or remote code execution via remote login. Fourteen units were distributed in the United States.
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.
Bel Gioioso Pepato Asiago cheese was not held at appropriate temperature, which could support pathogen growth. Affected products were distributed in Ohio, New York, and Pennsylvania 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.
Greco Sidari is recalling 1,375 cases of Marburger 40% Heavy Cream due to improper temperature storage that could support pathogen growth. The product was distributed to Ohio, New York, and Pennsylvania between November 26, 2023, and January 5, 2024.
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.
Becton Dickinson is recalling BD BBL Sensi Disc Cefepime antibiotic testing discs due to accuracy and reproducibility failures. These laboratory products may produce inaccurate test results, potentially leading to delayed diagnoses or inappropriate antibiotic treatment.
Greco Sidari is recalling SOPRA Ricotta Amalfi sold in Ohio, New York, and Pennsylvania because the product was not held at appropriate temperatures, which could allow pathogen growth and spoilage.
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.
Wegmans Food Markets is recalling its Ready To Bake Chocolate and Almond Variety Pk croissants due to undeclared soy lecithin. The product may pose a risk to consumers with soy allergies.
Brasseler USA recalls 440 dental burs due to right angle latch specification failure that prevents proper latching in dental handpieces.
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.
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.
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.
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.
The Flow-i C20 Anesthesia System has a cybersecurity vulnerability allowing potential remote access, denial of service attacks, or code execution. Healthcare facilities should contact the manufacturer for patches and guidance.
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.