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.
Thommen Medical AG is recalling impression coping units because the internal canal depth was not manufactured according to specifications, preventing firm connection to the dental implant. The product was distributed in Ohio and Kentucky.
Curaplex Nasal Intubation Kit recalled because the included endotracheal tube holder is incompatible with nasal intubation procedures, preventing practitioners from properly securing the tube.
A vascular guidewire introducer is recalled because internal voids in the hub may prevent proper guidewire passage, potentially delaying surgical procedures.
Medtronic is recalling Abre Venous Self-expanding Stent Systems due to a potential for sterile package breach. The recalled systems consist of three product numbers totaling 65 units distributed worldwide. No injuries have been reported.
Angiodynamics is recalling 58 units of its MINI STICK MAX guidewire introducer due to voids in the internal lumen that may prevent proper guidewire passage. Users may experience procedural delay requiring device exchange.
La Fiesta ground cinnamon (Canela Molida) is being recalled due to elevated lead levels. Affected products are 0.87oz bags with lot code 25033, distributed to retailers in California, Arizona, Washington, and Texas.
Landauer is permanently discontinuing the microStar Reader medical dosimetry system. The company is removing product documentation references and discontinuing use with medical dosimeters.
Angiodynamics is recalling 959 units of MINI STICK MAX guidewire introducers due to voids in the sheath hub that may prevent proper guidewire placement. Users may experience procedure delays and need to exchange equipment.
Angiodynamics is recalling certain MINI STICK MAX vascular guidewire introducer sheaths due to internal voids that may prevent guidewire passage during surgery, potentially causing procedural delays.
Angiodynamics recalls MINI STICK MAX guidewire introducer devices due to manufacturing defects in the internal lumen that may prevent guidewire passage and delay surgical procedures.
Angiodynamics is recalling 65 units of its MINI STICK MAX guidewire introducer sheath due to manufacturing defects that may prevent guidewires from passing through during surgical procedures.
Mckesson Medical-Surgical is recalling Steris Endo Cleaning Indicator VERIFY RESITEST devices due to temperature excursions that occurred on January 8, 2024. The temperature drop could cause the indicator to produce incorrect or delayed test results.
A Sekisui Diagnostics control kit for bacterial vaginosis testing was recalled after exposure to temperatures below the validated storage range for up to 60 minutes due to refrigerator mechanical failure.
Medtronic is recalling 4,343 units of DLP Vessel Cannula (Model REF 30000) due to incorrect labeling on three manufactured lots distributed globally.
Abbott Point of Care Control i-STAT Level 3 control material (Lot 121164) is being recalled due to temperature excursions in storage that could affect test accuracy. Affected units were distributed in Arizona, Pennsylvania, and Texas.
Randox Laboratories is recalling 1,764 units of Liquid Protein Calibrators used in immunoassays due to realignment of C3 and Haptoglobin to the correct reference material standard. Distribution was limited to seven U.S. states.
Angiodynamics is recalling 5,176 units of MINI STICK MAX guidewires due to manufacturing voids that prevent passage through the introducer during surgery. Surgeons may need to exchange the sheath to complete procedures.
Natus Neurology is recalling TENSIVE Conductive Adhesive Gel (Lot A0623009) after complaints of improper thickness, discoloration, and in one case, patient skin irritation following use.
Natus Neurology is recalling Sleep Supplies Start Kits due to defective conductive adhesive gel supplied by Parker Laboratories. The gel is too thick, discolored, and caused patient irritation in at least one case.
Angiodynamics is recalling MINI STICK MAX guidewire introducer sheaths due to manufacturing defects that may prevent guidewire passage. The defect may cause procedural delays requiring equipment exchange during vascular interventions.
CK Turkey and Cheese Sandwich is recalled for undeclared sesame allergen. The sandwich label lists only Wheat, Milk, and Soy allergens, missing sesame which poses risk to allergic consumers.
Capitol Commissary LLC recalled 1,382 units of Jacksons Turkey and Cheese Sandwich due to undeclared sesame. The product was distributed across seven Western states and may pose a risk to consumers with sesame allergies.
BrightFarms Southwest Chipotle Salad Kits are being recalled for potential Listeria monocytogenes contamination in the cotija cheese ingredient. Affected products have best-by dates from December 31, 2023 through February 22, 2024.
Medos is recalling CERENOVUS CEREBASE DA Guide Sheaths due to reports of fractures at the distal end. Fractures may delay surgical procedures or cause vascular injury.
Trader Joe's Company is recalling Trader Joe's Southwest Salad (SKU 56077), 9 oz. due to potential Listeria monocytogenes contamination. Approximately 800,955 units were distributed nationwide.