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.
One lot of Contra Gray Soft Turbo Plus dental prophylaxis cups may contain Contra Petite Web LF Soft Purple Cup dental angles instead. The recalled product was distributed in Indiana, Tennessee, and Missouri.
Family Dollar is recalling approximately 329,044 units of Oral B Mouth Sore Rinse 237ML because the product was stored outside of labeled temperature requirements. No illnesses or injuries have been reported.
Family Dollar recalls 329,044 units of ARC Teeth Whitening Pen sold between June and October 2023 across 22 states due to improper storage outside temperature requirements.
Medline Industries is recalling REMEDY Antifungal powder nationwide because it contains insufficient miconazole nitrate (the active ingredient). The product was shipped before assay testing was complete.
Stryker Corporation is recalling Disposable Spetzler-Malis Bipolar forceps due to a labeling error showing an incorrect expiration date. The label states a 54-month shelf life when the actual shelf life is 36 months.
Family Dollar recalled 329,044 First Response 2 CT units sold between June and October 2023 due to storage outside labeled temperature requirements. The recall affects 22 states.
VistaPharm is recalling Mycophenolate Mofetil Oral Suspension because the adaptor does not fit the bottle after reconstitution. Affected lots were distributed nationwide and to Saudi Arabia.
FreshPoint Bix Produce cantaloupes are being recalled due to potential Salmonella contamination. The recalled product was distributed to Iowa, Minnesota, North Dakota, and Wisconsin.
The Kitchen Garden Co, LLC is recalling Fine Sconehenge English Scones due to undeclared egg allergen. The scones, sold via the firm's website to customers in California and Nevada, may pose a risk to consumers with egg allergies.
Covidien recalls 5,709 stolen McGRATH MAC video laryngoscopes that failed quality tests. These defective devices risk failed intubation and may compromise airway management.
The Kitchen Garden Co, LLC recalls Fine Sconehenge Baking Company Cranberry Orange Scones due to undeclared egg allergen. Consumers with egg allergies should not consume the product.
The Kitchen Garden Co, LLC is recalling Fine Sconehenge Baking Company Chocolate Chip Scones because they contain undeclared egg allergen. The product was misbranded and poses a risk to consumers with egg allergies.
Asensus Surgical recalls 21 units of Senhance Surgical System due to uncontrolled laparoscope arm motion after surgeons disengage remote control. The malfunction has occurred and may recur on affected devices.
The Kitchen Garden Co, LLC is recalling Fine Sconehenge Lemon Raspberry Scones because they contain undeclared egg. People with egg allergies could have serious reactions.
Braga Fresh Foods is recalling Wegman's Organics Sweet Kale Chopped Salad Kit due to undeclared egg allergen. The product was distributed nationwide and may pose a risk to individuals with egg allergies.
Fine Sconehenge Baking Company is recalling Lemon Blueberry Scones sold through their website because they contain undeclared egg, a common allergen. Consumers with egg allergies should not consume this product.
Corin Ltd is recalling Unity Total Knee System inserts due to a labeling mix-up between batches 529803 and 532405, potentially affecting size 6 and size 7 designations.
Cosmedent is recalling the FlexiCup Composite Finishing & Polishing System due to reports that the elastomer cup material is crumbling. Approximately 7,400 packs distributed worldwide are affected.
GlaxoSmithKline is recalling TUMS antacid tablets in Lot KH5L due to glass mineral wool contamination. Affected consumers should stop use immediately.
Nature's Path Organic Dark Chocolate Chip Waffles are recalled because peanuts were not declared on the label, posing a risk to consumers with peanut allergies.
Randox Laboratories is recalling the RX Daytona Plus (without ISE) IVD Clinical Chemistry Analyzer due to a flaw in rerun settings that may cause incorrect test result reporting.
Siemens Cios Alpha (VA30) C-arm X-ray systems have a software issue that may not meet updated DIN and IEC standards. This defect could result in patient misdiagnosis or unnecessary repeat imaging.
GlaxoSmithKline is recalling TUMS Antacid 1000 mg chewable tablets in Assorted Berries flavor due to glass mineral wool contamination found in some bottles. Product was distributed nationwide.
Select Custom Solutions is recalling JayRobb Vanilla Flavored Egg White Protein Powder due to plastic contamination. Approximately 1,008 pouches distributed nationwide are affected.
Covidien recalled 42,367 McGrath Mac 2 disposable laryngoscope blades due to an ineffective anti-fog agent that may cause screen condensation and visual obstruction during intubation procedures.