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.
Medtronic is recalling 288 units of the Octopus Evolution AS Tissue Stabilizer Model TS2500 due to incorrect tubing positioning during manufacturing, where short and long tubes were attached to wrong locations.
Zimmer, Inc. is recalling the Persona Revision Trabecular Metal Femoral Distal Augment (Model 42-5572-066-10, Lot 66232947) after a complaint reported a posterior augment found inside the distal augment package.
Direct Rx is recalling Duloxetine D/R 30 mg capsules (also sold as Cymbalta) distributed nationwide because the drug contains N-nitroso-duloxetine impurity above FDA-recommended interim limits.
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA-cleared specifications. Affected kits were distributed nationwide.
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside FDA clearance. The affected kits have been distributed nationwide.
PFM Medical Inc. is recalling Multi-Snare Set catheters (5 mm and 10 mm sizes) because they failed biocompatibility testing for in-vitro cytotoxicity and could cause localized inflammation and tissue irritation if they contact a patient's blood vessels.
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA clearance. The affected kits were distributed nationwide.
The Harvard Drug Group LLC is recalling METHYLERGONOVINE MALEATE Tablets 0.2 mg because the drug may be subpotent (contain less active ingredient than intended). The recall affects approximately 790 cartons distributed nationwide.
Elevate Oral Care is recalling Povi-One 10% Povidone-Iodine Oral Antiseptic nationwide due to sub potency. The affected lots have expiration dates ranging from June 2026 to October 2026.
Amgen, Inc. is recalling Sensipar (cinacalcet) 60 mg tablets nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects 30-count bottles with Lot #1157055 and expiration date 1/31/2028.
El David Gelee Bonbons with fruits (400g boxes) are recalled due to undeclared FD&C Yellow 5 and FD&C Red 40 color additives. Consumers who have purchased this product should not consume it.
Amgen, Inc. is voluntarily recalling 9,565 bottles of Sensipar (cinacalcet) 30mg tablets nationwide due to CGMP manufacturing deviations. The recalled lot was distributed to patients taking the medication for secondary hyperparathyroidism.
Amgen is recalling specific lots of Corlanor (ivabradine) 7.5mg tablets nationwide due to the presence of a foreign substance. Patients should consult their healthcare provider before stopping this medication.
Ajanta Pharma USA Inc. is recalling Fenofibrate Capsules, USP 200 mg due to Current Good Manufacturing Practice (CGMP) deviations identified during production. The recall affects 3,648 bottles distributed nationwide.
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes because the products contain unapproved design changes that were not cleared by the FDA.
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes because the manufacturer made unapproved design changes not cleared by the FDA.
Medtronic Perfusion Systems is recalling the Octopus Evolution Tissue Stabilizer, Model TS2000, due to an assembly error where tubing was incorrectly positioned during manufacturing.
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA clearance requirements.
Amgen Inc. is recalling Corlanor (ivabradine) 5 mg tablets nationwide due to the presence of a foreign substance. The recall affects approximately 934,577 bottles distributed in the United States.
Produce Innovations is recalling roast beef and cheddar closed-face sandwiches that are labeled as turkey and cheddar. The mislabeling may pose a risk to consumers with turkey allergies.
ANI Pharmaceuticals is recalling Hydroxyzine Hydrochloride Oral Solution due to the presence of a foreign substance. The affected lot is S25133A, distributed nationwide.
Pending LLM rewrite. Source: FDA_DEVICE Z-2462-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-2489-2026.
Pending LLM rewrite. Source: FDA_DRUG D-0590-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-2461-2026.