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.
First Quality Produce is recalling diced cucumber (5-lb trays) due to potential Salmonella contamination. The recalled product was distributed to consignees in California and was not sold at retail.
The Kroger Co is recalling Deli Fresh Vegetable Trays that may contain previously recalled cucumbers with potential Salmonella contamination.
Olympus recalls the MAJ-891 endoscope forceps/irrigation plug nationwide because improper reprocessing may leave biomaterial inside the device, creating a contamination risk.
Medline Fluid Delivery Sets were incorrectly assembled with macro drip chambers instead of required micro drip chambers. The macro chamber delivers three times more fluid per drop, creating a risk of dosing errors.
Snack Buddies Cucumber Coins are being recalled due to potential Salmonella contamination. The affected products were distributed exclusively to California food-service establishments, not retail stores.
Pinsarella Food LLC is recalling Roman Pizza products due to undeclared wheat and soy allergens. The affected products were distributed to restaurants in California through food distributors.
GE Healthcare recalls certain nuclear medicine systems that could have been transported without proper detector support, risking detector falls and life-threatening injury.
GE Healthcare recalled 116 nuclear medicine imaging systems worldwide due to risk that systems transported without proper detector support could experience detector falls and life-threatening injury.
Sklar Instruments is recalling ECONO STERILE gynecological dilator kits nationwide due to packaging issues that may breach the sterile barrier, potentially affecting product safety.
Cardinal Health is recalling Presource surgical kits due to potential endotoxin contamination in non-sterile surgical strips and patties. The recall affects 512,786 units distributed worldwide.
Intuitive Surgical is recalling 8,578 units of Cadiere Forceps surgical instruments due to reports of frayed or broken grip cables. These reusable instruments were distributed throughout the United States and internationally.
Sklar Instruments is recalling 1,050 ECONO STERILE surgical retractors nationwide due to packaging defects that may compromise sterility. The affected kits have potential breaches in their sterile barriers.
Intuitive Surgical is recalling 8MM Tenaculum Forceps used with da Vinci X/Xi Surgical Systems due to pitch cable failures. These instruments are used for tissue manipulation and retraction during surgical procedures.
Intuitive Surgical is recalling 8MM Mega Suturecut ND surgical instruments due to increased complaints of frayed or broken grip cables that may affect instrument operation.
Sklar Instruments recalls 2,500 ECONO STERILE orthopedic probe kits due to packaging issues that may breach the sterile barrier. No illnesses or injuries have been reported.
Intuitive Surgical is recalling 8MM Potts Scissors due to frayed or broken grip cables that could affect instrument performance during surgical procedures.
Intuitive Surgical is recalling 147,006 units of 8MM Fenestrated Bipolar Forceps due to increased complaints of frayed or broken grip cables, which could impair surgical control.
Box label states diameter 4,5 X 18,0 mm but actual implant is 4,0 X 18,0 mm. If dentist drills to box specifications, the smaller implant will not fit and may require revision surgery.
Olympus Corporation recalls the LithoCrushV Single Use Mechanical Lithotriptor due to potential distal tip tearing during endoscopic procedures. The FDA Class II recall affects 989 units distributed nationwide.
Certain GE Healthcare nuclear medicine systems were potentially transported without proper detector support, risking detector fall and life-threatening injury. Affected facilities should have their equipment inspected before clinical use.
Augustine Temperature Management is recalling 817 units of its HotDog Patient Warming Temperature Management Controllers for a power-on self-test error code EA POST.
Intuitive Surgical, Inc. is recalling 8MM Force Bipolar surgical instruments due to increased complaints of frayed or broken grip cables on the reusable instruments.
Coloplast is recalling 36,369 X-Flow prostatectomy catheters due to a possible sterility issue detected at its manufacturing facility.
Intuitive Surgical recalls 1,036 units of 8MM Micro Bipolar Forceps due to increased complaints of frayed or broken grip cables that could affect instrument function during surgical procedures.
Sklar Instruments is recalling ECONO STERILE nasal procedure kits due to packaging issues that may compromise sterility. The recall affects 175 units distributed nationwide.