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.
HMC Farms Peaches Signature Farms 2lb bags have been recalled due to potential Listeria monocytogenes contamination. The affected product was distributed widely across the United States and internationally.
TGD Cuts, LLC is recalling Mixed Fruit Cube 1/2" products due to potential Salmonella contamination. The recall affects units distributed in Pennsylvania, New Jersey, Maryland, West Virginia, South Carolina, Virginia, Delaware, North Carolina, and New York.
TGD Cuts, LLC is recalling Melon Loupe/Dew Chunks packaged in film due to potential Salmonella contamination. The affected product was distributed in nine northeastern and mid-Atlantic states.
ResMed recalls 3.8 million AirTouch F20 full face masks with magnets that may interfere with active medical implants. Updated safety warnings regarding safe distances from medical devices are being issued.
Renaissance Food Group is recalling Fruit Medley products in 9 oz and 18 oz sizes due to Salmonella contamination. The affected products were distributed to Alabama, Georgia, Florida, North Carolina, and South Carolina.
HMC Farms Nectarines 4lb bags are recalled due to potential Listeria monocytogenes contamination. The recall affects 26 US states, Mexico, Canada, and Taiwan.
Nurse Assist LLC recalls sterile water injection and irrigation syringes for inadequate sterility assurance. Affected products may be nonsterile and could cause infection if used.
TGD Cuts, LLC is recalling fruit trays with dip due to potential Salmonella contamination. The affected products were distributed across nine states in the Northeast and Mid-Atlantic regions.
Kwik Trip Cantaloupe (Item 930541, 6 oz) is being recalled due to potential Salmonella contamination. Affected products were distributed in Iowa, Illinois, Michigan, Minnesota, South Dakota, and Wisconsin with sell-by dates from November 4 to December 3, 2023.
ResMed AirFit N20 Nasal Masks contain magnets that may interfere with active medical implants and ferromagnetic objects. The FDA classified this as Class I; ResMed is updating safety warnings with required distances.
Siemens RAPIDPoint 500 cartridges may produce inaccurate sodium measurements in blood samples, potentially delaying diagnosis or causing inappropriate treatment. The sodium sensor may show a negative bias, affecting patient care.
Maquet Cardiovascular is recalling the Acrobat-i Vacuum Positioner System because the positioner arm may fail to tighten or lock during normal use, which could affect surgical positioning.
Siemens RAPIDPoint 500 measurement cartridges may produce inaccurate sodium readings, risking delayed diagnosis of dangerous electrolyte imbalances or unnecessary treatment.
Fagron, Inc. is recalling Nystatin 5BU bulk powder for prescription compounding due to an incorrect assay strength label. The product was distributed to pharmacies and repacker/relabelers in the United States and Canada.
Philips is recalling Azurion ceiling-mount imaging systems because a rotation cover may fall if the L-arm collides with hospital equipment, potentially causing injury or affecting sterilization.
Exactech Equinoxe Reverse Shoulder implants have been recalled due to loss of vacuum in the storage bag. The manufacturer received 3 complaints involving 4 devices.
AC power adapters for LIFEPAK 15 Monitor/Defibrillators may fail to charge batteries or power on the device. Physio-Control is recalling 18,732 units manufactured between November 2021 and April 2023.
Philips North America is recalling 330 Philips Inclusive CT imaging systems due to software issues causing incorrect image display, errors in image interpretation, and patient exposure to incorrect images and system functions during clinical use.
Exactech is recalling the Novation Hip System due to loss of vacuum in the sterile packaging. The company has received complaints about this defect affecting 4 devices.
Exactech recalls certain Truliant Knee System units due to loss of vacuum in the inner vacuum bag. The affected units were distributed across multiple U.S. states and international locations.
CardioQuip LLC is recalling 2 units of its Model MCH-1000(m) Modular Cooler-Heater due to potential bacterial contamination that could result in patient infection. The affected devices are distributed in California, Texas, Pennsylvania, Washington, Ohio, and Nebraska.
Philips is recalling Allura imaging systems where the ceiling-mounted rotation cover may fall during equipment collisions, risking injury or sterility issues. Approximately 9,991 units are affected worldwide.
Exactech is recalling certain Optetrak Logic Knee System devices due to loss of vacuum in the inner-most vacuum bag. The company has received three complaints involving four affected devices.
Exactech is recalling two catalog numbers of Vantage Ankle System devices due to loss of vacuum in the inner-most vacuum bag. Three complaints have been received relating to four affected devices.
Siemens epoc NXS blood analysis systems have a software defect causing incorrect test results to be printed or transmitted. Results may include data from previous patients, potentially leading to misdiagnosis.