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.
Abiomed is recalling 2,364 units of the Impella RP Flex with SmartAssist due to risk of optical sensor damage from device interaction. Damage may cause temporary or permanent pump stop and loss of vital monitoring signals.
Hardies Fresh Foods is recalling certain packaged cucumbers distributed in Texas for potential Salmonella contamination. Consumers should not consume affected products.
The Kroger Co is recalling Small Veggie Platters (32 oz) because they may contain cut cucumbers previously recalled due to potential Salmonella contamination.
Certain VISIONIST CRT-P pacemakers with latent high battery impedance may initiate Safety Mode unexpectedly during normal operations. Manufactured before September 2018, 156,329 units were distributed worldwide.
Trokamed GmbH is recalling an endoscopic access sheath (18 Fr., 130 mm) used in gastroenterology and urology. Rapid fluid inflow may block outflow and cause dangerous pressure buildup inside the kidney.
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.
Boston Scientific's ACCOLADE Family pacemakers, including VALITUDE CRT-P models, are recalled due to battery impedance defects that could trigger unintended Safety Mode during normal operation.
New Age International recalls Daily Veggies Enoki Mushrooms due to potential Listeria monocytogenes contamination. The product was distributed in New York and Maryland; consumers should not consume it.
Trokamed is recalling a 20 Fr. endoscopic access overtube due to risk of obstruction and dangerous kidney pressure buildup during procedures. If inflow speed is too quick, rapid fluid flow can restrict outflow and cause intrarenal pressure to accumulate.
Boston Scientific is recalling certain ESSENTIO DR Pacemakers manufactured before September 2018 due to latent battery impedance that may cause Safety Mode malfunction during normal operations.
Abbey Specialty Foods is recalling Wicklow Gold Cheddar Tomato & Herb cheese distributed in Massachusetts, Colorado, and Ohio due to potential Listeria monocytogenes contamination.
Boston Scientific is recalling ACCOLADE DR Pacemakers built before September 2018 due to risk of unintended Safety Mode activation caused by battery impedance issues. The devices may enter Safety Mode during normal telemetry operations.
Orgain, LLC is recalling Orgain 30g Plant Protein powder (chocolate, lot #4172-02-P) due to potential contamination with undeclared peanuts. Consumers with peanut allergies should stop using the product.
First Quality Produce is recalling Cucumber Coins (sliced cucumbers in 5-lb trays) due to potential Salmonella contamination. The product was distributed to food service operators in California.
Alcon Research is voluntarily recalling Systane Lubricant Eye Drops, Ultra PF, due to non-sterility concerns. The recall affects 55,960 boxes distributed nationwide.
Trokamed's endoscopic access overtube may cause rapid pressure buildup in the kidney if inflow speed is too fast. The device can become obstructed by tissue and blood fragments, restricting outflow.
Abiomed is recalling 1,560 units of the Impella RP with SmartAssist pump due to risk of optical sensor damage from device interactions. Damaged sensors may cause temporary or permanent pump malfunction.
Boar's Head hummus platters are recalled because they may contain cucumbers previously recalled for potential Salmonella contamination. Products were distributed across multiple states.
Baxter Healthcare Corporation is recalling Welch Allyn Life2000 Ventilation Systems due to a battery charger malfunction that triggers an alarm and renders the ventilator inoperable.
Medline fluid delivery sets were assembled with a macro drip chamber instead of the required micro drip chamber, delivering three times more fluid per drop and risking patient fluid overload.
Wholesale Produce Supply is recalling cucumbers sold in multiple Midwest states and Canada due to potential Salmonella contamination. Consumers should not eat the affected product and should dispose of it safely.
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.
Baxter Healthcare is recalling 946 Welch Allyn Life2000 ventilators due to a battery charger defect that can trigger an alarm and render the device inoperable.
The Kroger Co is recalling Deli Fresh Vegetable Trays that may contain previously recalled cucumbers with potential Salmonella contamination.
Mercury Medical is recalling the Neo-Tee T-Piece Resuscitator due to an undersized spring in the circuit flow controller that may prevent reaching proper pressure ranges, potentially impairing emergency ventilation.