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.
D.O.R.C. Dutch Ophthalmic Research Center is recalling Directional Laser Probes for ophthalmic surgery due to difficulties extending, retracting, and directing the laser fiber. The recall affects 84 units distributed nationwide.
Angiodynamics is recalling 39 units of MINI STICK MAX vascular guidewire introducers due to voids in the sheath hub that may prevent guidewire passage during surgery, potentially delaying the procedure.
Albertsons is recalling Signature Select, Athens, and Cal Pia brand Bread Butter White Bread due to possible metal and plastic shavings in the product. The recall affects approximately 13,550 units distributed in California and Nevada.
Covidien is recalling Situate Laparotomy Sponges because some packs may contain improperly sterilized units lacking required RF detection features. Non-sterile sponges could cause infection, tissue trauma, and sepsis during surgery.
Angiodynamics vascular guidewire introducers (600 units) may have internal defects preventing proper function during surgery. Defects could cause procedure delays and require device exchange.
Angiodynamics recalls MINI STICK MAX vascular guidewire introducers due to internal lumen defects that may prevent the guidewire from passing through during surgery, potentially requiring device exchange.
Beckman Coulter recalls Access Total T4 thyroxine assay due to imprecision that may cause erroneous or delayed diagnostic results.
Bob Evans Original Mashed Potatoes (2 lbs) with UPC 75900005349 from batch KCL1 are being recalled due to potential red plastic contamination. No illnesses have been reported.
D.O.R.C. recalls 78 directional laser probes with Alcon/Lumenis connectors due to difficulties extending, retracting, or directing the laser fiber. The Class II recall affects units distributed across multiple U.S. states and Puerto Rico.
Abbott's i-STAT Level 1 control device is recalled because a refrigerator temperature excursion on January 8, 2024, could cause incorrect or delayed test results. The walk-in storage unit failed, causing temperatures to fall below the required range of 35.6-46.4°F.
Mc3 Inc is recalling 188 Nautilus Smart ECMO modules nationwide due to potential water path restrictions in the heat exchanger that may cause inadequate heat transfer and risk of hypothermia during use.
Eugia US LLC is recalling 43,920 vials of Nicardipine Hydrochloride Injection nationwide due to failure to meet organic impurity specifications. No illnesses have been reported.
El Chilar ground cinnamon (1.25 oz bags) is being recalled due to elevated levels of lead. Affected products were distributed in Maryland; consumers should not use them.
Ethos Bakery is recalling Vegan Pecan Oat Scones distributed in Washington because the product label fails to declare wheat as an allergen, despite wheat flour being present in the product.
ConvaTec is recalling specific lots of EsteemBody Soft Convex Drainable Pouches due to inconsistency in filter weld strength, affecting 6709 units distributed in the US and internationally.
Novitium Pharma LLC recalls Digoxin 125mcg tablets nationwide due to cross contamination with mycophenolate mofetil, a different medication. Patients receiving contaminated tablets could experience unintended drug effects.
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.
A Class II medical device recall has been issued for Directional Laser Probes due to potential difficulties extending, retracting, and directing the laser fiber tip. The issue affects 126 units distributed across multiple US states.
In2Bones, SAS is recalling I.B.S Compression screws due to a batch mix-up. Affected screws may have different lengths than indicated on their labels, creating a risk of improper surgical implantation.
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.
Eugia US LLC is recalling Nicardipine Hydrochloride Injection nationwide due to failed impurity specifications. The 335,940 affected vials contain organic impurities exceeding acceptable standards.
Baxter Healthcare is recalling HDS Traction Boot II units due to incorrect assembly. The boot key socket locking ridge faces upward, preventing proper attachment to the traction system.
Angiodynamics is recalling MINI STICK MAX guidewire introducers (155 units) due to manufacturing defects in the sheath hub that may prevent guidewire passage.
Hikma Pharmaceuticals is recalling Infumorph 200 (morphine sulfate) ampuls because the sterile filter in the carton has an earlier expiration date than the medication, potentially compromising sterility.
Angiodynamics recalls 130 MINI STICK MAX guidewire introducers due to hub voids that may prevent guidewire passage during vascular procedures. No injuries reported.