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.
Vermont Village Organic Unsweetened Apple Sauce (24oz) is being recalled due to elevated patulin levels. Consumers should not consume the product and should discard or return it.
BAPS Shayona is recalling Kopra Paak Coconut Fudge (12 oz, code A06D2023) for undeclared soy, a major allergen. The product was distributed to Alabama, Florida, Georgia, North Carolina, South Carolina, and Tennessee.
Stryker Medical is recalling ProCuity bed series model 3009 due to missing electrical safety test values. The beds pose a risk of electrical shock or tissue burn to patients.
Atrium Oasis chest drain devices were re-sterilized by a third party using unapproved packaging and sterilization processes lacking manufacturer validation. Affected devices were distributed in Virginia.
Thor Photomedicine is recalling 19 NovoTHOR Gen 2.0 red light therapy beds due to ball stud component failures that can cause canopy detachment or difficulty in lifting. The beds were distributed worldwide.
BAPS Shayona is recalling Mohanthal (chickpea flour fudge) distributed in six states due to undeclared soy and dyes (Yellow #5, #6). The product poses risk to consumers with soy allergies or sensitivities.
Elekta recalled its ELEKTA AXESSE radiation therapy system due to potential uncontrolled extension of detector arms if the microswitch is incorrectly configured. The recall affects 47 units distributed worldwide.
Elekta radiation therapy accelerators may experience uncontrolled detector arm extension due to an incorrectly set microswitch in the middle arm. The issue affects 315 units worldwide.
Staar Surgical is recalling 11 EVO+VISIAN implantable collamer lenses distributed across 38 US states because they may not meet manufacturing specifications. No illnesses or injuries have been reported.
BAPS Shayona is recalling Kesar Penda Ricotta fudge discs because they contain undeclared soy and Yellow #5 & #6 dyes. The product was distributed to six Southern states.
Abiomed is recalling Automated Impella Controller units with software versions V8.4 and V8.4.1 because a software issue may prevent proper pump connection detection. Affected devices were distributed in Arizona, California, Florida, New York, and Virginia.
Stryker is recalling ProCuity patient beds (model 3009) for missing required electrical safety test documentation, creating a risk of electrical shock or tissue burn.
Stryker is recalling ProCuity bed series model 3009 because they are missing electrical safety test values, presenting a risk of tissue burn or electrical shock to patients.
Garden of Life RM-10 mushroom supplement recalled due to undeclared soy, a common allergen. The recall affects 15,119 bottles distributed domestically and internationally; consumers with soy allergies should not use these products.
Garden of Life FYI ULTRA Joint & Cartilage Formula dietary supplement recalled due to undeclared soy. Consumers with soy allergies should not use affected bottles.
KinderFarms is recalling KinderMed KIDS' PAIN & FEVER Acetaminophen oral suspension nationwide due to failed impurity and degradation specifications that do not meet FDA standards.
Stryker is recalling ProCurity bed series (model 3009) due to missing electrical safety test values that could pose risk of electrical shock or tissue burn. Affected units were distributed nationwide and internationally.
Heartware is updating instructions for HVAD ventricular assist device implant kits to clarify Controller Fault alarm conditions and troubleshooting steps, as well as useful life information for system components.
Vyaire Medical recalled 188 Flexible Patient Circuit 3100A units distributed in Florida that were approved only for use outside the United States. The circuits were mistakenly distributed in the U.S. market.
BAPS Shayona is recalling Badam Pista Sandwich due to undeclared Yellow #5 and Green 3 color additives. The product was distributed to six states.
BAPS Shayona is recalling approximately 674 units of Motichur Ladoo across six states due to undeclared Yellow #5 and Yellow #6 food dyes discovered during an FDA inspection.
The FDA is issuing updated instructions for the HeartWare HVAD ventricular assist device to clarify when controller fault alarms sound and when device components should be replaced. No patient harm has been reported.
Luminex Corporation is recalling 222 kits (4,440 VERIGENE BC-GP Utility Trays) used in blood culture testing due to potentially defective utility trays. The affected lot (062123018C) expires December 20, 2023.
Sun Pharmaceutical is recalling Bupropion Hydrochloride Extended-Release Tablets 200 mg due to failed dissolution specifications. The recall affects 2,016 bottles with lot HAD0630A distributed nationwide.
Liberty Medical Solutions is recalling 473 Multi-Mode TENS stimulator units distributed in five states due to missing warnings and contraindications in instruction manuals.