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.
Gills Onions is recalling 1,600 pounds of Fresh Diced Red Onions due to potential contamination with Salmonella Thompson. The affected product was distributed to multiple U.S. states and Canadian provinces.
Olympus is recalling 1,154 EVIS EXERA II bronchovideoscope units due to risk of endobronchial combustion during high-frequency electrosurgical procedures when oxygen is supplied and electrode placement is inappropriate.
Gills Onions is recalling Imperial Fresh 4/5 LB slivered yellow onions due to potential contamination with Salmonella Thompson.
Gills Onions is recalling Imperial Fresh slivered yellow onions due to potential Salmonella Thompson contamination. The recall affects onions distributed across the United States and Canada.
Gills Onions is recalling Cross Valley Farms diced yellow onions due to potential Salmonella Thompson contamination. The product was distributed to 36 U.S. states and five Canadian provinces.
Gills Onions is recalling 8 oz cups of diced red onions due to potential Salmonella Thompson contamination. Products were distributed across the US and Canada.
Gills Onions is recalling 10 oz cups of diced mirepoix due to potential Salmonella Thompson contamination. Affected products were distributed across Canada and the United States.
Gills Onions is recalling diced red onions that may be contaminated with Salmonella Thompson. Consumers with affected product lots should not consume them.
Stryker Corporation is recalling 2,321 units of disposable bipolar forceps due to a labeling error. The product label shows a 54-month shelf life, but the actual shelf life is 36 months.
Gills Onions is recalling Cross Valley Farms fresh diced yellow onions due to potential Salmonella Thompson contamination. Consumers should not consume the affected product.
Magellan Diagnostics recalls LeadCare II Blood Lead Test Kits nationwide due to defective plastic caps on reagent tubes. A small percentage of caps may not seal properly, potentially leading to inaccurate test results.
Securitas Healthcare is recalling Arial Water Resistant Pendants (models 59360 and 2560-59360) due to premature battery depletion that may prevent emergency alarms from being received.
Gills Onions, LLC is recalling Cross Valley Farms fresh slivered yellow onions due to potential Salmonella Thompson contamination. Distribution affected the United States and Canada.
Stryker Corporation is recalling 2,321 units of Disposable Spetzler-Malis Bipolar forceps due to an expiration date labeling error. The label incorrectly shows a 54-month shelf life when the actual shelf life is 36 months.
Philips is recalling 46 CombiDiagnost R90 radiography systems nationwide due to potential ceiling mount failure that could allow suspended units to fall, posing an injury risk.
Edwards Lifesciences is recalling Fogarty Thru-Lumen Embolectomy Catheters that may deflate more slowly than normal, potentially affecting device function during vascular procedures.
Hinterland Dairy Inc is recalling Jalapeno Happy Jack Monterey Jack cheese due to potential E. coli contamination. The affected product was distributed in Iowa.
Philips DigitalDiagnost C90 ceiling-mounted radiographic systems may fail and fall. FDA Class II recall affects 143 units nationwide; facilities should contact Philips.
Stryker Corporation is recalling 2,321 units of disposable surgical forceps due to a labeling error. The label indicates a 54-month shelf life, but the products actually expire in 36 months.
B. Braun recalls 30 ML 2PORT burette assemblies (lot 0061766049) for potential leakage due to manufacturing defect. Leakage risks delayed therapy, bloodstream infection, and medication exposure to patients and healthcare workers.
Philips is recalling 13 DigitalDiagnost 4 Chest/Emergency radiographic imaging units due to a potential for ceiling-mounted units to fail and fall, posing injury risk.
Percussionaire Corporation recalled 212 Monitron II Waveform Analyzers due to screen freeze issues on visual displays. Affected units were serviced with PAL microprocessor chips and firmware updates.
Greenhead Lobster Products is recalling frozen and fresh ready-to-eat lobster meat that may be contaminated with Listeria monocytogenes. The recall affects multiple states.
Abbott Laboratories has recalled Similac Probiotic Tri-Blend infant supplement packets due to regulatory violations: the product was marketed without FDA approval as a new drug and contains an unsafe food additive.
Olympus Corporation is recalling 1,687 units of the EVIS EXERA III Gastrointestinal Videoscope nationwide due to sterilization failures that may occur when devices are reprocessed without adequate drying time in the endoscope channel.