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.
Covidien Custom Suture Packs (US1638 and US1756) are recalled due to a sterile barrier breach in the breather pouch, which may cause infection or vision loss during ophthalmic procedures.
Covidien is recalling Parietex Composite Mesh because the collagen film was positioned on the wrong side, which may cause delays in treatment, adhesions, erosion, migration, pain, fistula, hernia recurrence, or implant failure.
Accord Healthcare is recalling Rosuvastatin 10 mg tablets due to manufacturing deviations identified during FDA inspection. No illnesses or injuries have been reported.
Wright Medical Technology recalls ORTHOLOC 3DSi CLAW II bone fixation plates due to incorrect products placed in packages. Healthcare providers should verify product identification matches packaging before use.
Accord Healthcare is recalling 113,571 bottles of dofetilide capsules distributed in the US, Puerto Rico, and Canada due to Current Good Manufacturing Practice (CGMP) deviations found during FDA inspection. No illnesses have been reported.
CooperVision is recalling Biofinity XR Toric contact lenses manufactured with misaligned axis, resulting in incorrect lens power and poor visual acuity.
Unetixs Vascular is recalling the MultiLab Series II REVO vascular diagnostic device because faulty connectors may allow the air line to be misconnected to an IV line, potentially causing a dangerous air embolism.
Accord Healthcare is recalling 5,090 vials of Phenylephrine Hydrochloride Injection due to manufacturing deviations found during an FDA inspection. Affected batches include R2101570, R2101574, and R2101576, distributed in the United States, Puerto Rico, and Canada.
Snack Innovations Inc. is recalling Drizzilicious Birthday Cake Popcorn 3.6oz bags due to undeclared peanut residue. Consumers with peanut allergies should not consume this product.
Unetixs Vascular is recalling 1706 units of the MultiLab Series II 2CP & 2CP Express vascular diagnostic device due to luer fittings that could allow air lines to be misconnected to intravenous lines, potentially causing air embolism.
Accord Healthcare recalled 1.4 million bottles of Finasteride 1 mg tablets due to manufacturing quality deviations discovered during FDA inspection. No illnesses have been reported.
Encore Medical recalls EMPOWR VVC Knee Tibial Inserts due to reversed box labeling—large inserts marked as small and vice versa. Surgeons may implant the wrong size if the labeling discrepancy is not identified before surgery.
Summit Medical is recalling 30 Nasal Septal Buttons due to unsealed sterile pouches that compromise product sterility. Patients face potential infection risk from non-sterile device exposure.
Accord Healthcare is recalling Pravastatin Sodium 80 mg tablets due to manufacturing process deviations discovered during an FDA inspection. The recall affects approximately 1,970 bottles distributed in the United States, Puerto Rico, and Canada.
Alpenland International recalled Heilemann Confiserie chocolate treats after receiving a complaint of plastic in the product. The affected 3.5 oz boxes were distributed across 30 U.S. states.
Accord Healthcare recalls 139,332 bottles of ropinirole 0.25 mg tablets distributed in the US, Puerto Rico, and Canada due to manufacturing compliance deviations identified during FDA inspection.
Nephron Sterile Compounding Center is recalling 443,483 bottles of Norepinephrine Bitartrate injection nationwide due to lack of sterility assurance in the product.
Accord Healthcare recalls Atorvastatin Calcium 80 mg tablets due to manufacturing process deviations identified during FDA inspection. 72,376 bottles were distributed in the US, Puerto Rico, and Canada.
Covidien is recalling Surgidac Uncoated Braided Polyester sutures (5-0, 45cm) due to a sterile barrier breach in the breather pouch. This breach may cause infection or vision loss in ophthalmic patients undergoing direct surgical contact.
Accord Healthcare is recalling Glycopyrrolate Injection (4 mg/20 mL) from two batches due to CGMP deviations identified during FDA inspection. No illnesses have been reported.
The Harvard Drug Group is recalling Carbidopa and Levodopa Tablets due to inadequate sealing of the blister packaging. The recall affects Lot M04145 distributed nationwide.
Arroyabe Bonito Flakes White Meat Tuna is being recalled because dried fish bones were discovered in the cans, presenting a choking hazard. The affected product includes Lot Code L1104-1 and was distributed in Washington and Utah.
Stryker is recalling Hoffmann LRF Transport Strut devices due to oversized thread pitch that prevents the distal ring fixation from locking, affecting 488 units nationwide.
Maquet is recalling CARDIOHELP System components due to insufficient evidence of packaging sterility. Non-sterile medical devices could expose patients to infection, sepsis, or ischemia.
Stryker's Medivac Guardian 3L scanning labels may cause inaccurate blood loss estimates, potentially delaying treatment for postpartum hemorrhage. The recall affects 541 units distributed nationwide.