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.
Stradis Medical recalls 675 Henry Schein Universal Trays due to incomplete outer bag sealing that may compromise sterility. The defect affects surgical procedures nationwide and in Canada.
DeRoyal Industries voluntarily recalled 100 kits of its laminectomy spinal fusion pack after identifying a device defect. The recall affects medical facilities in 23 states.
Stradis Medical recalled Henry Schein Basic Pack medical and surgical procedure trays due to manufacturing defects causing incomplete outer bag seals that may compromise sterility. The affected kits were distributed nationwide in the US and Canada.
DeRoyal Industries recalled 48 kits of the TOTAL KNEE PACK surgical product in November 2022. The specific reason for the recall was not disclosed in the public notice.
Siemens linear accelerator systems may allow users to select the wrong treatment site, potentially delivering radiation to the wrong location. The FDA classified this Class II recall affecting 8 units across seven U.S. states.
Stradis Medical recalls medical and surgical procedure trays and kits due to incomplete outer bag sealing that may compromise sterility. Units were distributed nationwide in the US and Canada.
Stradis Medical is recalling a dental surgical pack because the outer bag may be incompletely sealed, potentially compromising sterility. Affected units should not be used.
DeRoyal Industries is recalling 68 kits of the CNRV Peripheral VAS Pack. The voluntary Class II recall affects healthcare facilities in 23 US states with specific lot numbers.
Stradis Healthcare is recalling 162 surgical implant trays distributed nationwide due to incomplete outer bag seals that may compromise sterility.
Stradis Healthcare is recalling 1-inch safety pins due to manufacturing defects that may result in incomplete sealing of outer bags, potentially compromising the sterility of medical and surgical procedure kits.
Stradis Medical is recalling catheter angiography procedure kits with potentially incompletely sealed outer bags that may compromise the sterile integrity of the medical devices.
Henry Schein Blue Tail Custom Pack surgical procedure trays are being recalled because manufacturing issues may have caused incomplete sealing of the outer bag, potentially compromising sterility.
Stradis Medical recalled 20 oral surgery implant packs with incomplete outer bag sealing that may compromise sterility. Affected lot numbers are 22228490663 and 22242491516, distributed in the US and Canada. No illnesses reported.
Stradis Medical is recalling approximately 300 Curved Tip Syringes because manufacturing defects may result in incomplete sealing of the sterile kit, potentially compromising product sterility.
FDA is recalling 51 DeRoyal HEART PACK medical device kits (Lot 57893436) distributed across 23 US states. The specific reason for this Class II recall has not been disclosed.
DeRoyal Industries is recalling 8 kits of its TOTAL HIP PACK (Lot 57460930) distributed across 23 U.S. states in a voluntary Class II FDA recall.
DeRoyal Industries is recalling 72 kits of TRACECART POSTEROR LAMI MICRODISC TRACECART devices distributed across 23 U.S. states in a voluntary Class II recall initiated by the manufacturer.
Zimmer Inc. is recalling NexGen Option Stemmed Tibial Components due to clinically and statistically significant higher revision rates when used with specific femoral components. The components are being removed from inventory.
HENRY SCHEIN Amnio Trays (Item No. 570-3059) manufactured by Stradis Medical are being recalled because the outer bag may be incompletely sealed, potentially compromising the sterility of the medical kit.
Stradis Medical is recalling surgical procedure trays due to incomplete sealing of the outer bag, which may compromise the sterility of the kit.
DeRoyal Industries is recalling 918 PICC line procedure packs containing 3M sterile drapes that were separately recalled. The affected kits were distributed across 23 U.S. states to healthcare facilities.
Stradis Medical recalls Henry Schein Basin Pack surgical trays due to potentially incomplete outer packaging seals that may compromise sterility of the medical kits.
DeRoyal is recalling 144 shoulder arthroscopy procedure packs that contain recalled 3M Health Care Steri Drapes. The packs were distributed across 23 U.S. states.
ConMed's electrosurgical suction coagulator devices may have blocked suction ports that prevent proper function during procedures. Affected devices could cause procedure delays and require alternative equipment.
DeRoyal TLIF procedure packs containing recalled 3M Health Care Steri Drapes are being recalled. The affected packs were distributed across multiple U.S. states.