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.
Dr. Reddy's Laboratories is recalling IBU (Ibuprofen) 800 mg prescription tablets nationwide due to failed quality specifications. Testing found unknown impurities exceeding acceptable limits.
Medline is recalling three procedural kits containing plastic syringes with leaks and breakage issues that may pose a risk to patient health. The kits have been distributed worldwide.
Stryker Corporation recalls iBur 3.0mm surgical burs used in neurosurgery, spinal, and ENT procedures due to potential overheating at the bur-shank interface. The heat risk may cause tissue damage requiring medical intervention.
La Superior Bakery is recalling Pan Guatemalteco pastries due to undeclared sesame seeds. Consumers with sesame allergies face risk of allergic reaction.
CVS Health and HEB Baby Premium Infant Formula with Iron is recalled due to vitamin D levels exceeding permitted maximums. The recall affects 16,500 units.
Beaver Visitec International, Inc. is recalling BVI CustomEyes Procedure Packs containing Sol-M manufactured syringes. The voluntary recall affects approximately 1,629 units distributed nationwide.
BVI voluntarily recalls CustomEyes Procedure Packs because they contain syringes recalled by their manufacturer, Sol-Millennium Medical, Inc. Approximately 94 units were distributed nationwide.
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical. The voluntary recall affects 247 units distributed nationwide.
Beaver Visitec International is recalling 880 units of BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-M, Inc., distributed nationwide in the United States.
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-Millennium Medical syringes due to a voluntary manufacturer recall. The affected packs have been distributed nationwide in the US.
Procedure packs containing Sol-M manufactured syringes are being voluntarily recalled nationwide. The affected product is part number 58000603.
Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing low dead space and luer slip tip syringes manufactured by Sol-Millennium Medical, Inc. These packs were distributed nationwide.
Beaver Visitec International recalls CustomEyes Procedure Packs because they contain Sol-Millennium Medical syringes subject to a voluntary recall. Fourteen units distributed nationwide.
Glenmark Pharmaceuticals recalls 2,404 bottles of Indomethacin Extended-Release Capsules nationwide due to failed dissolution specifications that could affect medication effectiveness.
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-M syringes due to a voluntary recall by the syringe manufacturer. The affected packs have been distributed nationwide.
Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing Sol-M syringes. The recall affects 98 units distributed nationwide.
Neurovision Medical Products recalls Cobra 3-Plate EMG ET Tubes due to mislabeling with incorrect tube size on the label. The error could affect proper product selection in clinical procedures.
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-M syringes following a voluntary recall initiated by syringe manufacturer Sol-Millennium Medical (Sol-M), Inc.
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical due to a supplier voluntary recall affecting 71 units nationwide.
Beaver Visitec International is recalling 505 CustomEyes Procedure Packs containing Sol-Millennium Medical syringes that are subject to a voluntary manufacturer recall.
BVI CustomEyes Procedure Packs containing syringes made by Sol-Millennium Medical (Sol-M) are being voluntarily recalled. These affected syringes are low dead space and luer slip tip 1ml models.
Beaver Visitec International is voluntarily recalling 82 units of CustomEyes Procedure Packs containing Sol-M syringes due to a manufacturer recall. Affected lot numbers 6070885 and 6074819.
Beaver Visitec International voluntarily recalls BVI CustomEyes Procedure Packs containing Sol-M manufactured syringes distributed nationwide.
Beaver Visitec International is voluntarily recalling 1,429 units of BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical. The packs were distributed nationwide.
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs because they contain syringes manufactured by Sol-Millennium Medical that are subject to a manufacturer's voluntary recall. 388 units were distributed nationwide.