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.

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8951–8975 of 27441

  • HighFDA (Devices)·Z-0430-2023·2022-12-21

    Arrow AutoCAT2 Intra-Aortic Balloon Pump short battery run-time issue

    Arrow International is recalling 88 units of Arrow AutoCAT2 Intra-Aortic Balloon Pumps worldwide due to a potential issue with short battery run-times. Affected cardiac support devices may not operate reliably.

    Product
    Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE REFURBISHED, REF IAP-0500X (IPN000328), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0513-2023·2022-12-21

    Medical and surgical procedure trays recalled for incomplete seal

    Stradis Medical recalls medical and surgical procedure trays due to manufacturing defects causing incomplete outer bag seals that may compromise kit sterility.

    Product
    HENRY SCHEIN, VEIN TRAY, Item No.570-2738,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-0580-2023·2022-12-21

    DeRoyal Cataract Procedure Packs Recalled Due to Defective Sterile Drapes

    DeRoyal Industries is recalling approximately 1,220 cataract procedure packs that contain recalled 3M Health Care Steri Drapes. The affected kits were distributed to healthcare facilities across 23 U.S. states.

    Product
    DeRoyal CATARACT PACK CSM, REF 89-6863
    Category
    Medical Device
    Distribution
    23 states
  • HighFDA (Devices)·Z-0662-2023·2022-12-21

    FDA Class II Recall: DeRoyal BIOPSY PACK Medical Device

    DeRoyal Industries has recalled 480 units of its BIOPSY PACK (REF 89-9614.07) in a voluntary, firm-initiated recall affecting 23 US states. The specific reason for the recall has not been disclosed.

    Product
    DeRoyal BIOPSY PACK, REF 89-9614.07
    Category
    Medical Device
    Distribution
    23 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
    23 states
  • HighFDA (Devices)·Z-0545-2023·2022-12-21

    Stradis Healthcare Vein RF Pack surgical trays recalled for incomplete outer bag seal

    Stradis Healthcare is recalling 400 units of Vein RF Pack surgical trays due to manufacturing defects that may result in incomplete outer bag sealing, potentially compromising sterility.

    Product
    STRADIS HEALTHCARE, Vein RF Pack, Item No.682-1942NL1,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-0703-2023·2022-12-21

    FDA Medical Device Recall: DeRoyal Pacemaker ICD Pack

    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.

    Product
    DeRoyal PACEMAKER ICD PACK, REF 89-10902.01
    Category
    Medical Device
    Distribution
    23 states
  • HighFDA (Devices)·Z-0561-2023·2022-12-21

    DeRoyal Oral Procedure Packs Recalled for Affected Steri Drapes

    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.

    Product
    DeRoyal MAJOR ORAL PACK RF, REF 89-3936.15
    Category
    Medical Device
    Distribution
    23 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
  • HighFDA (Devices)·Z-0548-2023·2022-12-21

    Stradis Healthcare Surgical Procedure Kits Recalled for Incomplete Sealing

    Stradis Medical recalls Vein & Laser surgical procedure kits due to incomplete outer bag sealing that may compromise sterility. The recall affects 10 units distributed in the US and Canada.

    Product
    STRADIS HEALTHCARE, Vein & Laser, Item No.682-334R1,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0557-2023·2022-12-21

    Henry Schein Vas Reversal Pack Surgical Kit Recalled for Incomplete Seal

    A surgical procedure kit is being recalled due to manufacturing conditions that may result in an incompletely sealed outer bag, potentially compromising sterility. Affected kits were distributed in the US and Canada.

    Product
    HENRY SCHEIN, Vas Reversal Pack, Item No.888-2549,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0559-2023·2022-12-21

    NUVASIVE MAGEC 2 Rod Spinal Bracing System Recalled for Sterile Packaging Failure

    NuVasive is recalling the MAGEC 2 Rod spinal bracing system due to potential failure of the sterile packaging barrier, which could compromise device sterility.

    Product
    NUVASIVE MAGEC MAGEC 2 Rod. The MAGEC System is used to brace the spine during growth to minimize the progression of scoliosis. REF Model Numbers/NSO Item #/Product Description MC2-4590S / PA0684-001 / MAGEC 2 Rod, 4.5mm 90mm Standard MC2-5590S / PA0684-002 / MAGEC 2 Rod
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0516-2023·2022-12-21

    Stradis Healthcare Major Extremity Surgical Kits Recalled for Potential Sterility Breach

    Stradis Healthcare is recalling Henry Schein Major Extremity surgical kits due to incomplete outer bag sealing that could compromise kit sterility. Affected kits were distributed nationwide in the US and Canada.

    Product
    HENRY SCHEIN, MAJOR EXTREMITY PACK, Item No.570-2783,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0609-2023·2022-12-21

    DeRoyal HEART PACK procedure kits recalled for defective component

    DeRoyal Industries is recalling 102 HEART PACK procedure kits (Lot 57367401, expiration 3/1/2025) distributed across 23 U.S. states because they contain recalled 3M Health Care Steri Drapes.

    Product
    DeRoyal HEART PACK, REF 89-8351.12
    Category
    Medical Device
    Distribution
    23 states
  • 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-0555-2023·2022-12-21

    Surgical procedure trays recalled due to incomplete outer bag sealing

    Stradis Healthcare is recalling surgical procedure trays that may have incompletely sealed outer bags, risking sterility breach. Sixteen units were distributed nationwide and in Canada.

    Product
    STRADIS HEALTHCARE, Breast, Item No.693-276,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0695-2023·2022-12-21

    Hip replacement surgical kits recalled by DeRoyal Industries

    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.

    Product
    DeRoyal ANTERIOR APPROACH TOTAL HIP A&B PGYBK, REF 89-10612.01
    Category
    Medical Device
    Distribution
    23 states
  • HighFDA (Devices)·Z-0490-2023·2022-12-21

    Surgical Procedure Tray Recall Due to Incomplete Packaging Seal

    Stradis Healthcare is recalling oral surgery trays with potentially incompletely sealed packaging that may compromise sterility. No illnesses reported.

    Product
    STRADIS HEALTHCARE, Surg Pk, Item No.40714IES, oral surgery tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0690-2023·2022-12-21

    FDA Recalls DeRoyal CNRV Spinal Pack Medical Devices

    DeRoyal has voluntarily recalled 69 kits of CNRV Spinal Pack medical devices distributed to 23 US states. The manufacturer initiated the recall on November 3, 2022.

    Product
    DeRoyal CNRV SPINAL PACK, REF 89-10532.03
    Category
    Medical Device
    Distribution
    23 states
  • HighFDA (Devices)·Z-0565-2023·2022-12-21

    DeRoyal Surgical Procedure Packs Recalled Due to Defective Steri Drapes

    DeRoyal is recalling procedure packs containing recalled 3M Steri Drapes. Affected lot 56181816 (exp. 10/1/2023) distributed across multiple U.S. states.

    Product
    DeRoyal PEDI ORTHO PACK, REF 89-5323.20
    Category
    Medical Device
    Distribution
    23 states
  • HighFDA (Devices)·Z-0558-2023·2022-12-21

    Surgical Procedure Trays Recalled Due to Potentially Compromised Sterility

    Stradis Healthcare is recalling 75 units of surgical procedure trays because their outer bags may be incompletely sealed, potentially compromising sterility.

    Product
    STRADIS HEALTHCARE, TIP, SURGE-O-VAC .125" GREEN, Item No.SS077225,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0542-2023·2022-12-21

    Stradis Healthcare surgical procedure kits recalled for incomplete outer bag sealing

    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.

    Product
    STRADIS HEALTHCARE, Surgery PK, Item No.682-1728,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0474-2023·2022-12-21

    Electrosurgical Suction Coagulator Devices Recalled Due to Potential Suction Port Blockage

    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.

    Product
    Foot Controlled Electrosurgical Suction Coagulator, Electrosurgical Suction Coagulator 10FR, Catalog Number 130187
    Category
    Medical Device
    Distribution
    Distributed nationwide