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.
Middlefield Original Cheese Co-op Horseradish Flavored Cheese, 8 oz, lot 2524061, is recalled for potential Listeria monocytogenes contamination. The FDA classified the action as Class I.
Middlefield Original Cheese Co-op Monterey Jack and Farmers Cheese are recalled for potential Listeria monocytogenes contamination. The FDA classified the action as Class I. 640 pounds are affected.
Deep Sprouted Moong, 16 oz, is recalled after the product tested positive for Salmonella. The FDA classified the action as Class I. 5,616 packets are affected.
Paneer Cheese in 5 lb vacuum-sealed bags, lot 2517061, distributed for foodservice, is recalled for potential Listeria monocytogenes contamination. The FDA classified the action as Class I.
Brie Royal Faucon, about 2.2 lb / 1 kg, batch 615, is recalled because it may be contaminated with Listeria monocytogenes. The FDA classified the action as Class I.
ELEOS Bowed Canal Filling Stems are recalled because an unidentified substance of unknown impact was found on devices during a retrospective evaluation. 30 units are affected.
Orascoptic custom loupes configured with Phantom frames are recalled because loupe nose pads containing nickel may cause an allergic reaction, following complaints. 10,611 units are affected.
H-E-B inControl Sterile Alcohol Pads, 100 per container, are recalled nationwide because isopropyl alcohol levels fall below the labeled concentration. The recall covers 300,000 pads.
American Contract Systems anterior hip, total knee and hip prosthesis packs are recalled because the firm cannot confirm that product sterilization assurance requirements were met. 588 units are affected.
American Contract Systems craniotomy and shunt procedure packs are recalled because the firm cannot confirm that product sterilization assurance requirements were met. 204 units are affected.
Rite Aid Pharmacy first aid alcohol prep pads are recalled nationwide because isopropyl alcohol levels fall below the labeled concentration. The recall covers 984,000 pads.
Two Akreos intraocular lenses from lot 1Q29212 are recalled after an off-power error produced a 16 diopter lens rather than the intended 3 diopter.
Orascoptic Dragonfly Nose Pad Accessory Kits are recalled because loupe nose pads containing nickel may cause an allergic reaction, following complaints. 743 kits are affected.
Good Neighbor Pharmacy Alcohol Prep Pads, distributed by AmerisourceBergen, are recalled nationwide because isopropyl alcohol levels fall below the labeled concentration. 66,000 pads are affected.
Corin Operating Tables are recalled because interference, such as from high-frequency surgical equipment used at the same time, can leave the table unresponsive to both the remote control and the override panel.
Hostess Ding Dongs in twin packs and 10- and 16-count cartons are recalled for mold, which the firm traced to a malfunctioning cooler after customer complaints rose. 60,630 cases are affected.
ReliOn Sterile Alcohol Swabs distributed by Walmart are recalled nationwide because isopropyl alcohol levels fall below the labeled concentration. The recall covers 3,456,000 pads.
American Contract Systems supplement, kidney perfusion and lapchol/appy packs are recalled because the firm cannot confirm that product sterilization assurance requirements were met. 6,617 units are affected.
GE HealthCare OEC 9800 and OEC 9900 Elite C-arm systems are recalled because impacted units are missing the full layer of lead tape in the collimator covers, slightly increasing radiation exposure.
American Contract Systems cysto and TUR basin packs are recalled because the firm cannot confirm that product sterilization assurance requirements were met. 1,127 units are affected.
American Contract Systems lap chole and laparoscopy packs are recalled because the firm cannot confirm that product sterilization assurance requirements were met. 1,233 units are affected.
Bardex Lubri-Sil I.C. Foley catheters and related tray systems are recalled because the catheter may have an obstructed lumen, which may prevent the bladder from draining. 175,158 units are affected.
American Contract Systems Born on Arrival kits and Labor & Delivery packs are recalled because the firm cannot confirm that product sterilization assurance requirements were met. 781 units are affected.
Orascoptic Dragonfly Essentials Kits are recalled because loupe nose pads containing nickel may cause an allergic reaction, following complaints. 32 kits are affected.
Medline kits containing BD SureStep Foley Tray Systems are recalled because the trays include incorrect product information insert sheets. Four units were distributed, all from the LAVH MINOR SKU.