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.
Wiers Farm Inc is recalling 148 cases of Plain Parsley due to potential Listeria monocytogenes contamination. The affected product was distributed across 17 states.
Wiers Farm Inc is recalling Serrano Peppers sold in 4oz bags due to potential Listeria monocytogenes contamination. The recall affects approximately 1,708 cases distributed across 16 states.
Wiers Farm is recalling organic zucchini squash due to potential Listeria monocytogenes contamination. The recall affects 337 cases across 17 states with lot numbers 240705 through 240712.
Wiers Farm is recalling cilantro packaged in 1-pound cartons due to potential Listeria monocytogenes contamination. The affected product was distributed to 2,798 cases across 16 U.S. states.
Panaderia Guatemex is recalling Pegado bread packaged in plastic bags due to undeclared soy allergen. Affected products were distributed in Georgia, Kentucky, and Tennessee.
GE Medical Systems recalled three SIGNA 7.0T MRI systems due to a software error that can exceed preset safety limits during imaging, potentially overheating implants in patients under certain conditions.
Philips IntelliVue Patient Monitor models with software L.x and M.x lack critical monitoring capabilities due to a software update. This could result in incorrect or delayed patient treatment.
Granules Pharmaceuticals Inc. is recalling Gabapentin Tablets 600 mg nationwide after fused Metformin ER tablets were found in bottles, creating a risk of unintended medication exposure.
FDA recall of BD PYXIS MEDBANK automated medication dispensing cabinets due to a software defect that prints incorrect bin information on restock labels, potentially leading to medication identification errors.
Lipari Foods is recalling Premo King Club Footlong sandwiches (UPC 612510094259) due to potential Salmonella contamination. The recall affects 216 cases distributed to retailers across 16 states; consumers should discard the product or return it to the store.
BD PYXIS MEDBANK automated medication dispensing cabinets with software version 3.9.1.9 may generate incorrect bin location labels during restocking. This could cause medications to be placed in wrong storage locations.
Panaderia Guatemex is recalling Sheca Anis bread products due to undeclared soy allergen. The recall affects 170 bags distributed in Georgia, Kentucky, and Tennessee.
Panaderia Guatemex is recalling 170 bags of Besos packaged bakery products distributed in Georgia, Kentucky, and Tennessee because they contain undeclared soy, a known allergen that poses a risk to consumers with soy allergies.
Palmer & Company is recalling Palmer Patriotic White Fudge Cookies in 7oz and 13.5oz sizes due to potential salmonella contamination. Affected products were distributed nationwide in the United States and Canada.
Panaderia Guatemex is recalling 170 bags of Roscas due to undeclared soy allergen. The product was distributed in Georgia, Kentucky, and Tennessee.
The Philips Azurion Interventional Fluoroscopic X-ray System may lose imaging functionality or experience longer restart times. The FDA is recalling approximately 3,011 units of this device worldwide.
GE SIGNA MR355 MRI systems running software versions SV25.5 or SV25.6 may cause implant overheating in certain scanning conditions. Risk occurs when using specific imaging sequences with the Optimized T2 FLAIR feature disabled.
A software issue in the BD PYXIS MEDBANK automated medication dispensing cabinet can cause incorrect bin labels to be printed for restock operations. This could lead to medication administration errors affecting patient safety.
Panaderia Guatemex is recalling Concha Mexicana pastries due to undeclared soy allergen. Consumers with soy allergies should not consume this product.
Panaderia Guatemex is recalling Corona brand bread packaged in plastic bags due to undeclared soy allergen. The affected product was distributed in Georgia, Kentucky, and Tennessee.
GE Medical Systems is recalling 72 SIGNA Prime MR imaging systems worldwide. Under specific imaging conditions, the systems can exceed prescribed radiofrequency safety limits, potentially causing MR conditional implants to overheat.
Philips IntelliVue Patient Monitors (MX400/450/500/550) with software versions L.x or M.x lack required monitoring capabilities due to removed software entitlements. The missing features could lead to incorrect or delayed patient treatment.
BioFire Diagnostics is recalling gastrointestinal diagnostic test kits due to false positive Vibrio results when used with certain transport mediums.
Steris Corporation recalls certain automated endoscope reprocessor hookups due to incorrect instructions in product documentation. Improper hookup connection could prevent proper endoscope disinfection, risking patient infection.
GE Medical Systems is recalling 404 SIGNA Premier MRI systems worldwide due to a software issue where radiofrequency energy can exceed prescribed safety limits during specific imaging sequences, potentially overheating MR-conditional implants.