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.
Bobo's Oat Bars - Peach are recalled due to undeclared coconut. The recall affects approximately 10,800 units sold under Lot Code 3J27111.
Covidien is recalling Valleylab FT10 FT Series Energy Platform devices due to a software issue that may render new systems inoperable. The recall affects 47,901 units distributed worldwide.
Fresenius Medical Care is recalling 69,590 bags of DELFLEX Peritoneal Dialysis Solution due to lack of sterility assurance. The affected lot was distributed nationwide.
Racine Danish Kringles Raspberry Kringle (14 oz., lot 23299) is being recalled due to undeclared tree nuts (pecans). Consumers with nut allergies should not consume this product.
Foremost Foods is recalling Pamana Premium Marinated Baby Bangus due to potential botulism risk. The frozen product in reduced-oxygen packaging lacks required freezing and thawing instructions.
Zimmer Biomet Spine Inc. is recalling Vitality Polyaxial Screws (7.5mm x 50mm) due to incorrect laser marking showing 7.5 x 40. Incorrect screw size could cause perforation and vascular damage during spinal surgery.
Medtronic is recalling Protege GPS Self-Expanding Peripheral Stent Systems due to seal defects in product packaging that could compromise sterility. Affected lot B644679 had national distribution.
Merit Medical Systems is recalling specific lots of microcatheter and infusion system devices because their sterility cannot be guaranteed. The devices were distributed worldwide including multiple US states and international locations.
Foremost Foods International is recalling Pamana Premium Bangus Belly frozen milkfish because the reduced-oxygen packaging lacks instructions to keep the product frozen and to thaw it properly, risking Clostridium botulinum toxin formation.
Wegmans Seafood Medley (1 lb packages, Lot 47117) is being recalled because it may contain plastic foreign objects. The recall affects products distributed in Massachusetts, Pennsylvania, and New York.
Scratch PASTA Co Marinara Sauce is recalled because the label does not list milk as a common allergen, despite the product containing milk in its butter ingredient.
Foremost Foods International is recalling Pamana Premium Marinated Bangus due to potential botulism risk. The frozen product in reduced oxygen packaging lacks required freezing and thawing instructions.
Natus Medical Incorporated is recalling 2,686 units of External Drainage System Collection Bags due to incomplete bioburden testing that prevents sterility assurance. Healthcare facilities and patients should contact the manufacturer or their healthcare provider for guidance.
Randox Laboratories recalls SEROLOGY ToRCH lgM 2022 POSITIVE CONTROL (Lot 157SR) due to decreased HSV Type 1/2 reactivity when tested on the DiaSorin Liaison XL analyzer. The product was distributed in New York and West Virginia.
Azurity Pharmaceuticals recalls Eprontia (topiramate) oral solution nationwide because routine stability testing found an out-of-specification impurity. The chemical defect raised concerns about the drug's purity and patient safety.
Seaway Pharma is recalling oxymetazoline nasal spray due to manufacturing process deviations. No contamination was found in the final products.
Quality Choice No Drip Nasal Decongestant is being recalled because purified water used in manufacturing may have contained microbial contamination. No contamination was detected in the final products.
Seaway Pharma Inc. recalled Premier Value Tussin Cough DM due to possible microbial contamination in manufacturing water. No contamination was found in finished products and no illnesses have been reported.
Abiomed has disabled four features in the Impella Connect software portal because the FDA has not evaluated them for safety and effectiveness.
Encore Medical is recalling 17 Reverse Shoulder System e+ surgical implants (Lot 381P1167) due to mislabeling. Affected units were distributed nationwide to multiple states.
Quality Choice No Drip nasal decongestant is being recalled due to a manufacturing deviation in water purification. No contamination was detected in the finished products.
Keystone Industries is recalling 336 units of KeySplint Hard Clear due to incorrect Instructions for Use packaged with the product. Affected units received KeySplint Soft instructions instead.
Encore Medical has voluntarily recalled a patella implant component (REF 130-03-738) due to mislabeling. The recall involves 2 units distributed nationwide.
Megadyne Medical Products is recalling approximately 2,312 MEGA SOFT Universal Plus Patient Return Electrodes due to reports of serious patient burn injuries, including third-degree burns. The product is now restricted to patients age 12 and older.
Megadyne Medical Products is recalling the MEGA SOFT Universal Plus Patient Return Electrode due to reports of serious burn injuries, including third-degree burns. The device should not be used in patients under 12 years old.