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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8926–8950 of 27441

  • 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-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-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-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
    23 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-0477-2023·2022-12-21

    Surgical Microscope Power Supply May Overheat and Cause Unexpected Shutdown

    Leica surgical microscopes (M530 OHX) may experience power supply overheating due to component overstressing, which can cause unexpected device shutdown. 148 units nationwide are affected.

    Product
    Leica MICROSYSTEMS M530 OHX, Part Number 10448737, surgical microscope system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-0471-2023·2022-12-21

    Knee implant tibial component recalled for higher revision rates

    Zimmer Biomet is voluntarily recalling 284 NexGen tibial knee components due to higher revision rates when paired with specific femoral components. Patients with these implant combinations should contact their surgeon.

    Product
    NexGen Option Stemmed Tibial Component Size 8, Item Number 00-5986-057-02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-0518-2023·2022-12-21

    Medical Procedure Trays Recalled for Potential Sterility Breach

    Stradis Healthcare is recalling 100 units of Henry Schein CATH PACK kits due to manufacturing defects that may leave outer bags incompletely sealed, potentially compromising sterility.

    Product
    HENRY SCHEIN, CATH PACK Item No.570-2789
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0670-2023·2022-12-21

    Surgical Spinal Fusion Device Recalled Across 23 US States

    DeRoyal is recalling its Posterior Lumbar Fusion Pack medical device across 23 states. The voluntary recall affects specific lot numbers; patients should consult their healthcare provider.

    Product
    DeRoyal POSTERIOR LUMBAR FUSION PACK, REF 89-10060.02
    Category
    Medical Device
    Distribution
    23 states
  • HighFDA (Devices)·Z-0515-2023·2022-12-21

    Medical and Surgical Procedure Trays Recalled Due to Incomplete Sealing

    Stradis Medical is recalling medical and surgical procedure kits with potentially incompletely sealed outer bags that may compromise sterility. Affected healthcare facilities should stop using these kits immediately.

    Product
    HENRY SCHEIN, OMFS, Item No.570-2779,
    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-0684-2023·2022-12-21

    DeRoyal Procedure Packs Recalled for Containing Recalled Steri Drapes

    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.

    Product
    DeRoyal CRANI PACK, REF 89-10242.04
    Category
    Medical Device
    Distribution
    23 states
  • HighFDA (Devices)·Z-0509-2023·2022-12-21

    Surgical Procedure Kits Recalled for Potential Sterility Seal Defect

    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.

    Product
    HENRY SCHEIN, BREAST PACK, Item No.570-2397
    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-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-0718-2023·2022-12-21

    Siemens allergy test kits recalled for false mold allergen reactivity results

    Siemens Healthcare Diagnostics is recalling 560 allergy diagnostic kits (Lot 565) due to potential for falsely elevated mold allergen reactivity, which may result in incorrect test results.

    Product
    IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests Japan Siemens Material Number (SMN): 10711939 For the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE mediated allergic disorders.
    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-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-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-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-0475-2023·2022-12-21

    Surgical microscope power supply may overheat and cause unexpected shutdown

    Leica Microsystems is recalling 43 Proveo 8 surgical microscopes nationwide due to a potential power supply defect that may cause device overheating and unexpected shutdown during use.

    Product
    Leica MICROSYSTEMS Proveo 8, Part Number 10449058, surgical microscope system
    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-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