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.
American Contract Systems Inc is recalling 90 Open Heart Adult Side A surgical kits due to inability to confirm sterilization requirements were met. Unsterilized devices could lose functionality and delay patient treatment.
Medline Industries is recalling Proxima Sterile Surgical Drape packs due to a potential breach in the pouch packaging that could lead to loss of sterility. The recall affects 1,490 units distributed nationwide.
American Contract Systems Inc. is recalling 303 Laparoscopy Packs (Models CALS41F, CALS41F-01, CALS41G) because sterilization assurance requirements could not be confirmed. Unsterilized instruments may cause infection or delayed treatment.
Merge Healthcare recalls Merge Cardio cardiovascular software due to measurement data inconsistency. When users manually edit or remeasure values in certain workflows, derived measurements may not match original measurements in patient reports.
Microstream intubated CO2 sampling lines may be difficult or impossible to disconnect from endotracheal tubes. This could delay necessary procedures and cause unintended extubation, potentially leading to respiratory failure.
Slate Run Pharmaceuticals is recalling Cinacalcet Hydrochloride Tablets 60 mg for containing nitrosamine impurity above acceptable daily intake limits. The recall affects 2,444 bottles distributed nationwide.
Optima Foods is recalling Domna's Bakery 24 PC Baklava Tray distributed in New York because it contains undeclared milk. Consumers with milk allergies should not consume this product.
American Contract Systems Inc is recalling CYSTO PACK cystoscopy kits because the company cannot confirm sterilization assurance requirements were met. Possible loss of functionality could delay or prolong patient treatment.
VERICIS Merge Cardio cardiovascular imaging software may display measurement values in patient reports that do not match original measurements when measurements are remeasured or manually edited. This affects 66 units distributed in the United States.
American Contract Systems Inc is recalling 144 CYSTO Model SACY80R kits due to inability to confirm sterilization requirements were met. Unsterilized devices may lose functionality and delay patient treatment.
Mylan Institutional is recalling 1,068 cartons of levothyroxine sodium 125 mcg tablets (Lot 3115773) distributed nationwide due to out-of-specification potency. The tablets contain higher-than-specified amounts, potentially resulting in excessive doses.
American Contract Systems Inc is recalling 17 MAJOR DIEP surgical kits because sterilization assurance requirements cannot be confirmed. This creates a risk of device malfunction and treatment delays.
American Contract Systems cannot confirm Major Vascular Pack surgical kits were properly sterilized. Sterilization assurance failure could result in loss of functionality and delayed patient treatment.
Lyons Magnus LLC is recalling Ready Care and Imperial brand vanilla shakes (4 oz) due to potential Listeria monocytogenes contamination. The affected products were distributed to long-term care facilities, skilled nursing homes, and hospitals across the U.S.
Growland Inc. is recalling Dried Longan Pulp products due to elevated sulfite levels. The affected product was distributed across seven states.
Great Lakes Cheese Co is recalling Happy Farms by ALDI Colby Jack shredded cheese due to potential stainless steel fragments. Affected products have best-by dates of July 13 or July 14, 2025.
CAPNOCHECK BCI Airway Adapters may break off when a valve or tube is attached, causing airway circuit disconnection and loss of ventilation. This could result in inability to ventilate, hypoxia, cardiopulmonary collapse, or death.
FUJIFILM's Synapse PACS Software versions 7.4.x incorrectly calculates patient age for infants under 3 months, potentially affecting clinical decisions. 104 units recalled in US and internationally.
Medline Industries is recalling CURAD Alcohol Prep Pads nationwide because they are subpotent. The recalled pads are sterile, medium, 2-ply alcohol prep pads distributed nationally.
Slate Run Pharmaceuticals is recalling Cinacalcet Hydrochloride Tablets 30 mg due to nitrosamine impurity above acceptable daily intake limits. 56,790 bottles were distributed to 8 wholesalers nationwide.
American Contract Systems Inc recalls the Born on Arrival Kit due to inability to confirm sterilization assurance. Unsterilized equipment could delay or prolong newborn treatment.
Microstream CO2 sampling line and airway adapter may be difficult or impossible to disconnect during procedures, potentially causing treatment delays and respiratory complications including hypoxia.
Remel, Inc. is recalling approximately 41 Zebra Thermal Barcode Printer GX430t power supply units due to a potential fire hazard. The power supplies may overheat, creating a fire risk.
Microstream CO2 sampling adapters may become difficult or impossible to disconnect from endotracheal tubes, potentially delaying critical procedures and causing respiratory complications.
Microstream Neonatal-Infant Intubated CO2 Filter Lines may become difficult or impossible to disconnect from endotracheal tubes during clinical procedures, potentially delaying treatment and causing unintended extubation.