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.
Giant Eagle is recalling a 16-ounce Peanut Butter Creme Brownie made with Jiff Peanut Butter due to potential Salmonella contamination. The product was distributed to Pennsylvania.
Pure Ground Ingredients has recalled specific lots of organic oregano leaf powder and ground oregano sold in Oregon, Wisconsin, Maryland, and Colorado due to potential Salmonella contamination.
Giant Eagle Torte Peanut Butter (62 oz, code GE 23984200000) is recalled due to potential Salmonella contamination from the Jiff peanut butter ingredient. Consumers should not consume this product.
Giant Eagle Petite Cake Peanut Butter 18Oz, distributed in Pennsylvania, is recalled due to potential Salmonella contamination. Products were manufactured using Jiff Peanut Butter.
Giant Eagle Brownie Classic Peanut Butter is recalled due to potential Salmonella contamination from the Jiff Peanut Butter ingredient. Affected product distributed in Pennsylvania.
Giant Eagle's GE Bakery peanut butter thumbprint cookies are recalled due to potential Salmonella contamination from Jiff peanut butter. The 12-ounce packages distributed in Pennsylvania should not be consumed.
Covidien recalls Palindrome Precision SI chronic dialysis catheters due to a potential leaking condition in the hub that may cause unanticipated fluid return during use.
Siemens Dimension CTNI cardiac troponin test is recalled for positive bias (falsely elevated readings) in Lithium Heparin plasma samples, which may lead to misdiagnosis of myocardial infarction.
Chromsystems is recalling MassCheck Amino Acid Acylcarnitines dried blood spot control material due to too-low glycine concentration in batch 2821. The defect was found in units distributed to New York, Ohio, and Connecticut.
Fresenius Medical Care recalled NaturaLyte 2301 dialysate in Texas and Louisiana after exposure to below-recommended storage temperatures. The exposure may cause packaging leaks, potentially leading to biological contamination and bloodstream infection risk.
EAT REAL FOOD LLC is recalling Culina Plant Based Yogurt nationwide due to potential glass fragments in the product. Affected units were distributed to all states.
Ossur has recalled 410 Variflex Suba Junior prosthetic feet due to cracking and breaking under impact stress. The device is designed for children and adolescents worldwide.
EAT REAL FOOD LLC is recalling Culina Plant Based Blueberry Lavender Yogurt due to potential glass fragments. Affected lots were distributed nationwide with best-by dates in October and November 2022.
EAT REAL FOOD LLC is recalling Plant Based Yogurt Culina Mango Orange Blossom due to potential glass contamination. The affected lot code is 07422CBCUCYMOB0723 with best-by date 11/13/2022, distributed nationwide.
Paris Brothers Inc is recalling Mild Cheddar Cheese (UPC 033954252225) due to Listeria in environmental samples. The affected lots (05042022 and 05052022) were distributed to wholesalers, retailers, and food service establishments.
EAT REAL FOOD LLC is recalling Plant Based Yogurt Culina Bourbon Vanilla in 5 oz. glass jars nationwide due to potential glass fragments in the product. Consumers should not consume products with the affected lot codes.
Rayner is recalling RayOne intraocular lens injection systems because the outer package is mislabeled and contains a different lens strength than indicated. Approximately 162 devices were distributed in 13 US states.
Milton Creamery Prairie Breeze cheese is being recalled due to environmental samples testing positive for Listeria. The product was distributed to wholesale, retail, and food service locations.
Culina Strawberry Rose plant-based yogurt is being recalled because glass may be present in the product. The recall affects 13,725 cases distributed nationwide.
Radiometer Medical is recalling ABL800 Flex Analyzers that may produce biased measurements in sodium, calcium, and potassium levels. Approximately 1,489 analyzers are affected worldwide.
EAT REAL FOOD LLC is recalling Plant Based Yogurt Culina Peach Cashew due to potential glass contamination. The product was distributed nationwide in 13,725 cases.
Covidien is recalling EEA Autosuture Circular Staplers (25mm) because the staple guide may not be securely attached and could disengage during use, potentially allowing the device to cut tissue without forming staples.
Wedgewood Village Pharmacy is recalling Boric Acid 600 mg vaginal suppositories (Lot #000-03843532) nationwide due to insanitary manufacturing conditions and lack of processing controls detected during an FDA inspection. No illnesses have been reported.
Abbott recalls 191 TactiCath cardiac ablation catheters that may display incorrect error messages when connected to the EnSite Precision Navigation System, potentially causing user confusion.
Siemens imaging systems with syngo VE20 software may display CT images mirrored horizontally and vertically when loading Toshiba data, potentially causing misinterpretation of patient positioning and inappropriate treatment.