The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Filters

Agency

Category

Minimum severity

Clear filters

10376–10400 of 13717

  • HighFDA (Devices)·Z-0574-2023·2022-12-21

    FDA Class II recall: DeRoyal surgical procedure pack distributed to multiple states

    DeRoyal Industries voluntarily recalled 3 kits of its OPEN SHOULDER PROCEDURE PACK RF (Lot 56391733, expiring 3/1/2024) starting November 2022. The recall affects multiple U.S. states.

    Product
    DeRoyal OPEN SHOULDER PROCEDURE PACK RF, REF 89-6629.07
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0546-2023·2022-12-21

    Stradis Healthcare Venous Access Pack Recalled for Potential Sterility Breach

    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.

    Product
    STRADIS HEALTHCARE, VENOUS ACCESS PACK, Item No.682-1993R1,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0453-2023·2022-12-21

    Intra-Aortic Balloon Pump Recalled for Potential Short Battery Runtime

    The Arrow AutoCAT2WAVE intra-aortic balloon pump is recalled due to a potential issue with short battery run-times. The FDA Class I recall affects 4 units distributed worldwide.

    Product
    Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500NL (IPN000326), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0528-2023·2022-12-21

    Medical Procedure Trays Recalled for Incomplete Outer Bag Sealing

    Stradis Healthcare recalls Henry Schein Rhino Pack surgical trays due to potentially incomplete outer bag sealing that may compromise kit sterility. The recall affects 328 units distributed in the US and Canada.

    Product
    HENRY SCHEIN, RHINO PACK, Item No.570-3070
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0485-2023·2022-12-21

    Stradis Healthcare Surgical Pack Recall for Compromised Sterility

    Stradis Healthcare is recalling surgical kits because the outer bag may be incompletely sealed, potentially compromising the sterility of the product.

    Product
    STRADIS HEALTHCARE, Surg Pack, Item No.40450SMS, dental
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0488-2023·2022-12-21

    Stradis Healthcare Oral Surgery Implant Packs Recalled for Incomplete Seal Defect

    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.

    Product
    STRADIS HEALTHCARE, Basic Implant Pack, Item No.40561BIP, oral surgery tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0598-2023·2022-12-21

    DeRoyal Spinal Fusion Procedure Packs Recalled for 3M Drape Issue

    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.

    Product
    DeRoyal SPINAL FUSION PACK, REF 89-7515.14
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0532-2023·2022-12-21

    FDA recalls Henry Schein bone marrow kit for defective seal

    Henry Schein bone marrow kits may have incompletely sealed outer bags, compromising sterility. Affected units were distributed in the US and Canada.

    Product
    HENRY SCHEIN, BONE MARROW KIT, Item No.570-3092
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0529-2023·2022-12-21

    Surgical Procedure Kits Recalled Due to Incomplete Outer Bag Sealing

    Stradis Healthcare is recalling Henry Schein Custom PK 2 surgical procedure kits due to manufacturing defects that may result in incomplete outer bag sealing, potentially compromising sterility. The recall affects 27 units distributed nationwide in the US and Canada.

    Product
    HENRY SCHEIN, CUSTOM PK 2, Item No.570-3072
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0503-2023·2022-12-21

    Medical Trays Recalled for Potentially Compromised Sterility from Incomplete Sealing

    Stradis Medical is recalling 800 units of HENRY SCHEIN Vein Clinics 1 surgical trays because the outer bag may be incompletely sealed, potentially compromising sterility. No infections have been reported.

    Product
    HENRY SCHEIN, Vein Clinics 1, Item No.570-1426
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0510-2023·2022-12-21

    Stradis Medical gynecological surgical kit recalled due to potential sterility breach

    Stradis Medical is recalling Henry Schein GYN Pack surgical kits with potentially incompletely sealed outer bags that may compromise sterility. The affected kits were distributed nationwide in the US and Canada.

    Product
    HENRY SCHEIN, GYN PACK, Item No.570-2625
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0655-2023·2022-12-21

    DeRoyal Shoulder Kit Subject to FDA Class II Recall

    DeRoyal Industries Inc is recalling 14 shoulder kits (Lot 56580884, expiring 12/1/2024) distributed to healthcare facilities in 23 states. The company initiated a voluntary Class II recall with the FDA.

    Product
    DeRoyal SHOULDER KIT, REF 89-9497.08
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0712-2023·2022-12-21

    DeRoyal Cataract Pack Surgical Kit Class II Recall

    DeRoyal Industries has recalled the DeRoyal CATARACT PACK (368 kits) in a voluntary Class II recall. Affected lot numbers are 55990451 and 56615717 with expiration 08/01/2024.

    Product
    DeRoyal CATARACT PACK, REF 89-9241.03
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0651-2023·2022-12-21

    Medical device shoulder pack recalled by DeRoyal Industries

    DeRoyal Industries recalled 48 units of its shoulder pack medical device (Lot 57755295) on November 3, 2022. The specific reason for the recall was not disclosed in available documentation.

    Product
    DeRoyal SHOULDER PACK, REF 89-9449.13
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0554-2023·2022-12-21

    Angio Pack surgical trays recalled for incomplete sealing and sterility breach

    Stradis Healthcare is recalling Angio Pack surgical trays due to manufacturing defects that may leave the outer bag incompletely sealed, compromising product sterility. Affected units were distributed nationwide in the US and Canada.

    Product
    STRADIS HEALTHCARE, Angio Pack, Item No.686-199,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0505-2023·2022-12-21

    Surgical Pain Tray Outer Bag May Not Be Properly Sealed

    Stradis Healthcare is recalling Henry Schein Surgical Pain Trays due to potential incomplete sealing of outer bags, which may compromise sterility. Healthcare providers and facilities should stop using affected trays and contact their supplier for replacement.

    Product
    HENRY SCHEIN, SURGICAL PAIN TRAY, Item No.570-1482
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0667-2023·2022-12-21

    DeRoyal ACDF surgical implant kit recall, Class II, reason undisclosed

    DeRoyal is recalling 63 ACDF surgical implant kits distributed to 23 US states. This is a voluntary, Class II recall announced November 2022, with no reported illnesses or injuries.

    Product
    DeRoyal ACDF PACK PGYBK A PACK / B PACK, REF 89-9997.06
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0484-2023·2022-12-21

    BASIC IMPLANT PACK Recalled for Incomplete Outer Bag Sealing

    Stradis Medical is recalling the BASIC IMPLANT PACK (Item 40310SBI) due to incomplete outer bag sealing that may compromise sterility. 80 units were distributed nationwide and in Canada.

    Product
    BASIC IMPLANT PACK, Item No. 40310SBI, oral surgery tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0567-2023·2022-12-21

    DeRoyal Total Knee Procedure Pack Recalled for Defective Steri Drapes

    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.

    Product
    GEO-MED TOTAL KNEE PACK A & B PGYK, REF 89-5796.13
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0501-2023·2022-12-21

    Stradis Healthcare surgical procedure trays recalled for incomplete packaging seals

    Stradis Medical is recalling medical and surgical procedure trays with incomplete outer bag sealing, which may compromise sterility. The recall affects 150 units distributed nationwide in the US and Canada.

    Product
    STRADIS HEALTHCARE, PROBE COVER W/GEL PACK, Item No.525-071, general surgery tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0638-2023·2022-12-21

    FDA Class II recall of DeRoyal FOOT PACK medical devices

    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.

    Product
    DeRoyal FOOT PACK, REF 89-9252.06
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0581-2023·2022-12-21

    DeRoyal Cannulated Hip Packs Recalled for Defective Steri Drapes

    DeRoyal Industries is recalling 108 kits of Cannulated Hip Procedure Packs because they contain 3M Steri Drapes that have been recalled. Affected lots were distributed across 23 U.S. states.

    Product
    DeRoyal CANNULTED HIP PACK CSM, REF 89-6977.09
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0629-2023·2022-12-21

    Medical Device: DeRoyal HEART B PACK Recalled by FDA

    DeRoyal Industries initiated a Class II recall of its HEART B PACK medical device kit affecting 68 units distributed across 23 US states (Lot 56613762, expires 6/1/2026). The specific reason for recall is not available in source documentation.

    Product
    DeRoyal KIT HEART B PACK, REF 89-9042.07
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0522-2023·2022-12-21

    Surgical Procedure Trays Recalled for Incomplete Sterile Barrier Sealing

    Stradis Medical recalls Henry Schein surgical procedure trays due to incomplete outer bag sealing that may compromise sterility. No injuries reported.

    Product
    HENRY SCHEIN, LOOP RECORDER PACK, Item No.570-2891
    Category
    Medical Device
    Distribution
    Distributed nationwide