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 the agency’s own highest classification or reported deaths or serious injuries, 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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11101–11125 of 39932

  • HighFDA (Devices)·Z-0633-2023·2022-12-21

    DeRoyal Laminectomy Spinal Fusion Pack Recalled by FDA (Class II)

    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.

    Product
    DeRoyal LAMINECTOMY SPINAL FUSION PACK, REF 89-9105.10
    Category
    Medical Device
    Distribution
    23 states
  • HighFDA (Devices)·Z-0512-2023·2022-12-21

    Medical and Surgical Procedure Trays Recalled for Incomplete Seal

    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.

    Product
    HENRY SCHEIN, BASIC PACK, Item No.570-2719, UDI/DI (case) H65857027191, UDI/DI (kit)M75257027190, Serial/Lot Numbers: 22242489505
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0645-2023·2022-12-21

    Medical Device Recall: DeRoyal TOTAL KNEE PACK surgical kit

    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.

    Product
    DeRoyal TOTAL KNEE PACK, REF 89-9300.08
    Category
    Medical Device
    Distribution
    23 states
  • HighFDA (Devices)·Z-0472-2023·2022-12-21

    Linear accelerator software addresses potential wrong-site treatment risk

    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.

    Product
    ARTISTE, ONCOR and PRIMUS with syngo RT Therapist with software version 4.3.1 MR3. Material Number: 8162815 Intended Use: Family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0536-2023·2022-12-21

    Stradis Healthcare Medical and Surgical Trays Recalled for Incomplete Bag Sealing

    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.

    Product
    STRADIS HEALTHCARE, Lipo, Item No.681-254,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0497-2023·2022-12-21

    Dental Surgical Pack Recalled Due to Incomplete Sterile Seal

    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.

    Product
    Surgical room, DENTAL SURGICAL PACK, Item No.41236SDSP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0689-2023·2022-12-21

    Medical Device Recall: DeRoyal CNRV Peripheral VAS Pack

    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.

    Product
    DeRoyal CNRV PERIPHERAL VAS PACK, REF 89-10530.03
    Category
    Medical Device
    Distribution
    23 states
  • HighFDA (Devices)·Z-0494-2023·2022-12-21

    Surgical Implant Trays Recalled for Incomplete Package Seal

    Stradis Healthcare is recalling 162 surgical implant trays distributed nationwide due to incomplete outer bag seals that may compromise sterility.

    Product
    Surgical room, Implant Pack, Item No.41111UTI, oral surgery tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0499-2023·2022-12-21

    Stradis Healthcare Safety Pins Recalled for Potential Sterility Breach

    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.

    Product
    STRADIS HEALTHCARE, SAFETY PINS, SMALL 1" Item No.515-001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0525-2023·2022-12-21

    Stradis Healthcare catheter angiography kits recalled for defective sterile sealing

    Stradis Medical is recalling catheter angiography procedure kits with potentially incompletely sealed outer bags that may compromise the sterile integrity of the medical devices.

    Product
    HENRY SCHEIN, CATH ANGIO PACK, Item No.570-2930
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0531-2023·2022-12-21

    Medical Surgical Trays and Kits Recalled for Incomplete Outer Bag Sealing

    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.

    Product
    HENRY SCHEIN, Blue Tail Custom Pack, Item No.570-3091,
    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-0535-2023·2022-12-21

    Stradis Healthcare Curved Tip Syringes Recalled Due to Incomplete Sterile Sealing

    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.

    Product
    STRADIS HEALTHCARE, CURVED TIP SYRINGE, Item No.60060GCTS,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0456-2023·2022-12-21

    Intra-Aortic Balloon Pump Recalled for Potential Battery Run-Time Issue

    Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump devices are being recalled worldwide due to a potential issue with short battery run-times. Healthcare providers and patients should contact the manufacturer for guidance.

    Product
    Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500J (IPN000334), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0610-2023·2022-12-21

    FDA Recalls DeRoyal HEART PACK Medical Device Kits

    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.

    Product
    DeRoyal HEART PACK, REF 89-8351.13
    Category
    Medical Device
    Distribution
    23 states
  • HighFDA (Devices)·Z-0635-2023·2022-12-21

    DeRoyal hip surgical pack recalled in voluntary Class II action

    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.

    Product
    DeRoyal TOTAL HIP PACK, REF 89-9113.07
    Category
    Medical Device
    Distribution
    23 states
  • HighFDA (Devices)·Z-0708-2023·2022-12-21

    DeRoyal recalls Class II TRACECART POSTEROR LAMI MICRODISC device

    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.

    Product
    DeRoyal TRACECART POSTEROR LAMI MICRODISC TRACECART, REF 53-1960.02
    Category
    Medical Device
    Distribution
    23 states
  • HighFDA (Devices)·Z-0468-2023·2022-12-21

    Zimmer Recalls NexGen Stemmed Tibial Components Due to Higher Revision Rates

    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.

    Product
    NexGen Option Stemmed Tibial Component Size 5, Item Number 00-5986-047-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0527-2023·2022-12-21

    HENRY SCHEIN Amnio Trays Recalled for Incomplete Outer Bag Seal

    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.

    Product
    HENRY SCHEIN, Amnio Tray, Item No.570-3059,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0551-2023·2022-12-21

    Medical Surgical Trays: Incomplete Outer Bag Sealing May Breach Sterility

    Stradis Medical is recalling surgical procedure trays due to incomplete sealing of the outer bag, which may compromise the sterility of the kit.

    Product
    STRADIS HEALTHCARE, Vein, Item No.682-577,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0569-2023·2022-12-21

    DeRoyal PICC line trays recalled due to sterile drape defects

    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.

    Product
    DeRoyal PICC LINE TRAY PGYBK, REF 89-6150.13
    Category
    Medical Device
    Distribution
    23 states
  • HighFDA (Devices)·Z-0507-2023·2022-12-21

    Surgical Procedure Trays Recalled for Potential Sterility Breach

    Stradis Medical recalls Henry Schein Basin Pack surgical trays due to potentially incomplete outer packaging seals that may compromise sterility of the medical kits.

    Product
    HENRY SCHEIN, Basin Pack, Item No.570-1692
    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
  • HighFDA (Devices)·Z-0626-2023·2022-12-21

    DeRoyal TLIF Procedure Packs Recalled Due to Included 3M Steri Drapes

    DeRoyal TLIF procedure packs containing recalled 3M Health Care Steri Drapes are being recalled. The affected packs were distributed across multiple U.S. states.

    Product
    DeRoyal TLIF PACK, REF 89-8780.04
    Category
    Medical Device
    Distribution
    23 states