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.
Qiagen's FGFR RGQ RT-PCR Kit may produce false positive results, leading to incorrect lab reports. This could expose cancer patients to inappropriate or suboptimal treatment.
Multiple Arborio rice products are being recalled by Woodland Foods LLC due to possible presence of glass pieces. Consumers should not use the affected products.
Clinical Innovations is recalling Sweetums 24% sucrose solution vials due to complaints of leaking, black liquid, and black particulates in product vials. The recall affects neonatal products distributed nationwide and internationally.
Siemens has recalled Artis Q and Artis Q.zen X-ray imaging systems due to a potential X-ray tube hardware defect. In rare cases, if error detection fails, the system will not be able to release X-ray until shut down; 1,389 units are affected globally.
ERG Foods is recalling ERG! Energy Apricot P'Butter Fruit and Nut Bars due to undeclared oats. The product may pose a risk to consumers with oat allergies.
Yem Foods LLC is recalling Priyems Mango Pickles (1lb/454g) due to undeclared wheat starch from asafoetida. Consumers with wheat allergies may be at risk.
Qiagen's therascreen FGFR RGQ RT-PCR Kit is being recalled for increased false positive results in 29 distributed kits. False positives could lead to incorrect lab reports and inappropriate cancer treatment for patients.
A software defect in the Pentacam AXL Wave eye imaging device's IOL calculator may inaccurately reflect alignment axis and incision position for toric lens surgeries. This affects 21 systems distributed across the U.S.
Family Dollar is recalling Colgate OPTIC WHITE CHARCOAL COOL MINT toothpaste (Net Weight 4.2 oz., UPC 0 35000 97872 1) distributed to stores in 11 states due to improper temperature storage during manufacturing.
Corin Ltd is recalling a hip implant stem component (Model 588.3800) after some units failed fatigue testing. The affected devices were distributed to New Jersey only.
Oxford Immunotec recalled 81 T-SPOT.TB diagnostic test kits (Lot TEC4000098) due to storage equipment failure that kept products outside the validated 2-8°C temperature range. The excursion may affect test accuracy.
A software error in the Pentacam HR eye imaging device causes inaccurate IOL calculator output for toric intraocular lens surgical planning. Nineteen systems are affected.
Medtronic is recalling EverFlex peripheral stents worldwide due to risk of partial deployment. Updated instructions provide a manual deployment workaround to mitigate potential harms.
Philips DigitalDiagnost C50 1.1 radiography systems contain a firmware defect in the Wallstand VS2 board that may cause incorrect radiation dose and anatomic marker misalignment. Eleven affected systems were distributed nationwide.
Clinical Innovations is recalling Sweetums 24% sucrose solution vials due to reports of leaking containers and contamination with black liquid and particulates. The product is used in hospital settings including neonatal intensive care units.
Aggredyne, Inc. is recalling the AggreGuide A-100 Instrument due to a software design defect that causes the device to run assays at 0 RPM, resulting in no blood mixing and inaccurate test results displayed as Low.
Oxford Immunotec is recalling 47 units of the T-Cell Xtend REF TTK.610 US test kit due to equipment failure that caused improper storage temperatures outside the validated range. Affected devices may have been compromised.
Family Dollar Stores is recalling 1,120 packages of Colgate OPTIC WHITE PRO SERIES toothpaste due to improper temperature storage conditions that deviate from cGMP standards.
Teva Pharmaceuticals is recalling Neomycin Sulfate Tablets because teflon was found in the active ingredient. Affected lot numbers: 3007830, 3007746, 3007829.
Aesculap Implant Systems LLC recalls ENNOVATE SET SCREW spine implants because packages may contain incorrect screws. Six units distributed in Georgia and Texas.
Great Value Chopped Walnuts pouches containing pecans have been recalled from Walmart distribution centers in North Carolina and Florida. The product was mislabeled, which may affect consumers with nut allergies.
Qiagen Sciences is recalling therascreen FGFR RT-PCR kits due to increased false positive rates. False results could lead patients to receive unnecessary cancer treatment.
Colgate Anticavity Fluoride Toothpaste, Optic White Renewal was recalled after being stored outside appropriate temperature conditions. The recall affects 840 packages distributed to Family Dollar stores in 11 states.
Oxford Immunotec is recalling 6 units of AIM-V Medium (Lot 100380) distributed in seven U.S. states due to equipment failure causing storage outside the validated 2-8°C temperature range for longer than the validated duration.
Family Dollar is recalling Colgate Whitening Mouthwash OPTIC WHITE ICY FRESH MINT due to temperature storage deviations. 840 packages were distributed to Family Dollar stores in multiple states.