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.
B.C. Williams Bakery Service, Inc is recalling its spice cake mix in 50 lb. bags due to undeclared milk allergen. The product was distributed nationwide under Batch 221.
B.C. Williams Bakery Service is recalling Bread and Roll Mix sold nationwide due to undeclared milk allergen. Consumers with milk allergies could have serious allergic reactions if they consume this product.
Outside The Breadbox bread crumbs are being recalled due to undeclared egg and milk allergens. The recall affects 4,497 units distributed across eight states.
Everpress Juice is recalling JUICE from the Raw DETOX GREENS due to under-processing that may allow pathogenic bacteria to be present. The affected product was distributed across 23 states.
Boston Scientific is recalling 588 units of HOT AXIOS biliary stents worldwide due to reports of deployment and expansion failures that may require additional endoscopic or surgical intervention.
Tai Phat Wholesalers, LLC is recalling Sofit Seedless Red Dates due to undeclared sulfites, an allergen. The 12 oz packages were distributed to Florida, Georgia, Iowa, and North Carolina.
FDA Class I recall of AXIOS Stents due to reported deployment and expansion failures. Affected patients may require device exchange or additional surgical intervention to remove the stent and close the puncture site.
Boston Scientific is recalling the AXIOS Stent and Electrocautery-Enhanced Delivery System (20mm x 10mm) due to reports of stent deployment and expansion failures that may require additional surgical or endoscopic intervention.
Everpress Juice is recalling JUICE from the Raw pineapple mint due to under-processing that may allow pathogenic bacteria to survive. The product was distributed across multiple states.
Everpress Juice is recalling JUICE from the Raw, a cashew milk product, due to potential pathogenic bacteria from under-processing. The product was distributed across multiple U.S. states.
Boston Scientific recalls HOT AXIOS 8mm stent delivery system for deployment and expansion failures. The devices may require surgical intervention to remove the stent and close puncture sites.
Boston Scientific is recalling 266 units of the HOT AXIOS Stent due to deployment and expansion issues that may require additional surgical intervention to remove the stent and close the puncture site.
JUICE from the Raw cashew coffee milk was under-processed and may contain pathogenic bacteria. The FDA issued a Class I recall; consumers should not use the product.
Sea Moss Gel Superfood (Lemon Pie flavor) is being recalled due to potential Clostridium botulinum contamination. The product was distributed nationwide through retail and online channels.
Olympus is recalling 4,183 Single Use 3-Lumen Sphincterotome V devices because some units did not undergo thermoforming, which could cause deformation and loss of performance.
Olympus recalls approximately 125 units of the Disposable Triple Lumen Sphincterotome (Model KD-411Q-0720) worldwide due to thermoforming defects that could cause device deformation and loss of performance.
Vortex Surgical is recalling its I2 Injection Kits (model VS0500) due to potential voids in pouch seals that could compromise the sterile barrier and cause infection. Affected are 14,789 units distributed nationwide and internationally.
Olympus Corporation recalls 93 Single-Use 3-Lumen Sphincterotome V devices due to improper thermoforming that may cause deformation and performance loss. Affected devices were distributed nationwide and internationally.
Prima Foods is recalling BarbaCuban Ram Air Red Zesty Ketchup due to undeclared quinine. The product was distributed in Florida; consumers should not consume and should dispose of the product.
Beckman Coulter is recalling specific lots of COULTER DxH Diluent due to elevated background counts in platelet Daily Checks when used with UniCel DxH analyzers. This can affect test result accuracy.
Olympus is recalling 886 units of its Disposable Triple Lumen Sphincterotome (Model KD-401Q-0330) because some devices may not have undergone proper thermoforming and could deform and lose performance during use.
Fujirebio's Lumipulse pTau 217 Plasma Controls may produce inaccurate test results, causing false positive or indeterminate readings. This could lead to incorrect Alzheimer's disease diagnosis or unnecessary clinical testing.
Molift 4-point sling bars are being recalled due to a bolt defect caused by material deformation between the lifting bar and device arm, which prevents proper device functionality.
Olympus has recalled Single Use 3-Lumen Sphincterotome V devices (Model KD-V411M-0725) worldwide because some units may not have undergone proper thermoforming, which could cause deformation and performance loss.
VANTIVE US HEALTHCARE LLC is recalling 2,724 units of OXIRIS SET dialyzers nationwide due to potential dislodgement of the deaeration chamber, which could impair device function.