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.
The FDA has recalled DeRoyal CRANI PACK devices (Lot 57389117, expiring 9/1/2026) due to a device defect. The recall affects 16 kits distributed across 23 US states.
Stradis Medical recalls medical and surgical procedure trays due to manufacturing defects causing incomplete outer bag seals that may compromise kit sterility.
Stradis Healthcare recalls its Phlebectomy Pack (Item No. 682-001) due to incomplete sealing of outer bags, which may compromise sterility of surgical kits distributed nationwide.
DeRoyal cataract procedure packs containing recalled 3M Health Care Steri Drapes are being recalled. The recall includes 520 kits distributed to healthcare facilities.
Ethicon recalls PDS II violet monofilament sutures due to significantly reduced knot tensile strength, posing risk of intra-operative breakage in surgical procedures. The affected lot was distributed internationally to Canada, Japan, Australia, and New Zealand.
DeRoyal Industries is recalling 90 kits of its Pacemaker ICD Pack (Lot 56705350, expiring June 1, 2026) distributed across 23 US states. The specific reason for this voluntary, firm-initiated recall is not disclosed in the FDA notice.
DeRoyal CRANI PACK procedure kits are being recalled because they contain 3M Health Care Steri Drapes that were previously recalled. Affected kits were distributed to medical facilities across multiple U.S. states.
DeRoyal Industries Inc has recalled 19 anterior approach total hip replacement surgical kits distributed across 23 U.S. states. This Class II recall was initiated voluntarily by the manufacturer.
DeRoyal Industries Inc has recalled 350 kits of the DeRoyal FOOT PACK medical device in a Class II FDA recall. The specific reason for the recall was not publicly disclosed in available agency records.
DeRoyal Industries initiated a voluntary recall of its PACEMAKER ICD PACK (Lot 57805969, exp. 11/1/2026). The specific reason for recall is not provided in available source documentation. Affected units were distributed across 23 U.S. states.
Stradis Healthcare angioplasty procedure trays may have incompletely sealed outer bags, risking sterility compromise. Affected units should not be used pending further instructions.
Zimmer is recalling NexGen Option Stemmed Tibial Components due to higher revision rates when used with certain femoral components in knee replacements.
Stradis Medical is recalling Henry Schein breast procedure kits distributed nationwide in the US and Canada due to incomplete outer bag sealing that may compromise sterility. No illnesses reported.
Stradis Medical is recalling surgical procedure trays due to manufacturing defects that may leave outer bags incompletely sealed, potentially breaching kit sterility. No illnesses have been reported.
Stradis Medical is recalling Henry Schein ILR Insertion Trays due to incomplete outer bag sealing that may compromise sterility. No illnesses have been reported.
Stradis Medical is recalling Venous Access Packs because the outer bag may be incompletely sealed, potentially compromising the sterility of the kit. Affected units were distributed in the US and Canada.
Stradis Healthcare is recalling cotton applicator 3 inch kits used in medical and surgical procedures due to incomplete outer bag sealing that may compromise kit sterility. Kits were distributed nationwide in the U.S. and Canada.
DeRoyal Industries is recalling 79 units of GEO-MED TOTAL KNEE PACK A & B due to defective 3M Steri Drapes included in the procedure packs. The affected units were distributed across 23 states.
DeRoyal Industries is recalling MAJOR ORAL PACK RF kits containing recalled 3M Health Care Steri Drapes. The affected lots were distributed to healthcare facilities in 23 US states.
St. Jean's Coast Mountain Resources Ltd. is recalling canned Wild Pacific Sardines in tomato sauce due to high histamine levels. The affected product was distributed wholesale to 148 retail customers in the western United States.
Surgical procedure kits supplied by Henry Schein may have incompletely sealed outer bags, potentially compromising sterility. Affected units should not be used.
Zimmer is voluntarily recalling NexGen Option Stemmed Tibial Component Size 7 (1,049 units) due to higher-than-expected revision rates when used with specific femoral components, based on UK registry data.
Stradis Healthcare has recalled surgical procedure kits due to incomplete outer bag sealing that may compromise sterility. Affected units (40 units, lot 22235489419) were distributed across the United States and Canada.
Stradis Healthcare is recalling oral surgery trays with potentially incompletely sealed packaging that may compromise sterility. No illnesses reported.
DeRoyal spinal fusion procedure packs containing recalled 3M Health Care Steri Drapes are being recalled. Affected kits were distributed to healthcare facilities across 23 U.S. states.