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.
Fresh & Ready Foods is recalling Garlic Pesto Pasta due to Listeria monocytogenes detected on food contact surfaces at the manufacturing facility.
Fresh & Ready Foods LLC is recalling Fresh Take Crave Away Turkey Cranberry Multigrain Sandwiches due to Listeria monocytogenes detected on food contact surfaces at the manufacturing facility.
Fresh & Ready Foods LLC is recalling City Point Market Fresh Food to Go Protein Snack due to Listeria monocytogenes detected on food contact surfaces in the manufacturing facility. The recall affects 139,863 units distributed to military and government facilities in California, Nevada, Arizona, and Washington.
Fresh & Ready Foods LLC is recalling Turkey & Cheese Mega Sandwiches (7.5oz) due to Listeria Monocytogenes detected on food contact surfaces in the manufacturing facility.
Rocky Mountain Chocolate Factory is recalling diced almonds due to an undeclared milk allergen. Consumers with milk allergies should not consume the product.
Silex Medical is recalling Signature Laparoscopic Atraumatic Grasper instruments (Model 5864000) due to incomplete insulation on the shaft that leaves an exposed area near the rotator wheel, posing an electrical safety risk during surgical use.
Beckman Coulter is recalling sample probes with defective tips used in clinical chemistry analyzers. The defective probes may dispense lower sample concentrations, potentially leading to false low test results and delayed diagnosis.
Healthmark Industries is recalling ChannelCheck Convenience Pack Pre-filled Water Syringes (Models UCC-222CP and UCC-222-ESP) because contamination was found in duodenoscope samples linked to the syringes, which were improperly used outside their intended purpose.
Silex Medical is recalling the Signature Laparoscopic Instruments Allis Clamp Grasper due to incomplete insulation on the shaft, leaving an exposed area that could pose an electrical hazard during surgical procedures.
Silex Medical is recalling Signature Laparoscopic Instruments (Model 5881033) because insulation on the shaft does not fully extend to the proximal end, leaving an exposed area near the rotator wheel.
GNC Holdings LLC is recalling GNC Women's 30+ Vitapak due to undeclared fish allergen (parvalbumin). The product was distributed across multiple states.
Mozarc Medical US LLC is recalling Palindrome Precision Chronic Hemodialysis Catheter Sport Pack units due to a potential breach of sterile barrier packaging. Affected units were distributed worldwide including the US, Canada, and Mexico.
Giant Instant Oatmeal Raisins and Spice is being recalled because walnuts are not declared on the outer packaging, though they appear on the inner packaging. Consumers with walnut allergies who rely on outer-package labeling are at risk.
Luminex is recalling VERIGENE Gram Negative Blood Culture test cartridges due to a consumable issue that may produce incorrect results on a small portion of one lot.
Nature's Eudos Distributors LLC is recalling Eudos Bronquilan due to undeclared food color additives (FD&C Yellow #5, FD&C Blue #1, and FD&C Red #40). Consumers with allergies or sensitivities to these dyes should not use the product.
Mozarc Medical is recalling Palindrome Precision HSI Chronic Hemodialysis Catheter Sport Packs due to a potential breach of sterile barrier packaging that could compromise the catheter's sterility.
Mexquisite, Inc. is recalling Salsa Cilantro in 8.5lb plastic jugs due to potential foreign object contamination. The product was distributed to Texas and California.
Dexcom G7 iOS App version 2.7.0 can enter a state where glucose readings freeze and alerts do not trigger, risking missed detection of dangerously high or low blood sugar. Other connected devices like Apple Watch and insulin pumps continue to receive glucose data directly from the transmitter.
Beckman Coulter is recalling the Access Testosterone assay (Catalog Number 33560) due to inadequate maintenance on manufacturing equipment that caused cross-contamination in testosterone reagent packs, which could result in inaccurate patient test results.
Silex Medical is recalling 2 units of a Signature Laparoscopic Instruments Dolphin Nose Grasper with Rotating Shaft due to incomplete insulation on the shaft, leaving an exposed area near the rotator wheel.
Mozarc Medical is recalling MAHURKAR Chronic Hemodialysis Catheter Sport Pack units due to a potential breach in sterile barrier packaging that could compromise the product's sterility.
Torrent Pharma Inc. is recalling Fluoxetine Tablets USP 20 mg due to the presence of N-Nitroso Fluoxetine exceeding the interim acceptable intake limit. The affected lot is distributed nationwide.
Silex Medical is recalling the Signature Laparoscopic Alligator Grasper with Rotating Shaft (Model 5863050) because insulation on the tube does not fully extend to the proximal end of the shaft, leaving an exposed uninsulated area near the rotator wheel.
Mozarc Medical is recalling Palindrome Precision H Chronic Hemodialysis Catheter Sport Pack units due to a potential breach of sterile barrier packaging. The affected catheter models were distributed nationwide in the US and in Canada and Mexico.
Mozarc Medical US LLC is recalling Palindrome Precision SI Chronic Hemodialysis Catheters (Sport Pack) due to a potential breach of sterile barrier packaging. Approximately 95,938 units distributed nationwide and in Canada and Mexico are affected.