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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10276–10300 of 40095

  • HighFDA (Devices)·Z-1526-2023·2023-05-10

    LINK SLED Knee Implant System recalled for early aseptic loosening

    The LINK SLED Knee System ALL POLY TIBIAL COMPONENT (18 units) is recalled due to early aseptic loosening and increased wear caused by suboptimal positioning or inadequate cementing technique, which may require earlier-than-expected revision surgery.

    Product
    LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13X58MM Item Number: 15-2028/16
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1475-2023·2023-05-10

    Steris surgical light handle covers may detach during procedures

    Steris surgical light handle covers may detach during use, risking contamination of the sterile field and patient injury. The FDA is recalling approximately 1.4 million affected covers.

    Product
    Steris Lighting and Visualization Systems, Sterile Light Handle Cover (LB53)- Surgical light handle covers, including disposable surgical light handle covers are designed to fit over surgical light handles for sterile surgeon control. REF: LB53
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1516-2023·2023-05-10

    LINK SLED Knee System tibial component subject to surgical technique amendment

    A knee implant component is being recalled due to risks of early loosening or increased wear caused by suboptimal implant positioning or inadequate cementing. Manufacturers are providing updated surgical guidance.

    Product
    LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 50MM Item Number: 15-2028/06
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1532-2023·2023-05-10

    LINK SLED Knee System Tibial Component Recall Due to Early Loosening Risk

    Linkbio Corp. is recalling LINK SLED Knee System tibial components due to risk of early aseptic loosening and increased wear from improper implant positioning or inadequate cementing. Patients may require revision surgery earlier than expected.

    Product
    LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 50 MM Item Number: 15-2030/08
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1511-2023·2023-05-10

    Knee implant tibial component recalled for aseptic loosening risk

    Linkbio Corp. recalls LINK SLED Knee System tibial component due to risks of early aseptic loosening and implant wear from improper surgical positioning or cementing technique.

    Product
    LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 45MM Item Number: 15-2028/01
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1502-2023·2023-05-10

    Radiological imaging system may mismatch patient records

    GE Healthcare's Centricity PACS-IW radiological system can mismatch information between patients when correcting patient or study data. No illnesses reported.

    Product
    Centricity PACS-IW, Product ID Numbers: a) 2041037-001, b) 2042988-001, c) 2049587-009, d) 2049587-011, e) 2049587-012, f) 2049587-015, g) 2052829-001, h) Not applicable; Radiological Image Processing System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1548-2023·2023-05-10

    LINK SLED knee implant system surgical technique amendment for aseptic loosening prevention

    Linkbio Corp. is updating surgical technique guidance for the LINK SLED knee implant system to prevent early aseptic loosening or implant wear caused by suboptimal positioning or cementing technique during surgery.

    Product
    LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 50 MM Item Number: 15-2230/08
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1510-2023·2023-05-10

    LINK SLED knee implant system recalled for inadequate surgical technique

    Linkbio Corp. is amending training for the LINK SLED Knee System due to early implant loosening and wear caused by inadequate surgical positioning and cementing techniques. Healthcare providers should implement updated surgical guidance.

    Product
    LINK SLED Knee System: ENDO SLED KNEE FEM COMP, Large Item Number: 15-2020/60
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1527-2023·2023-05-10

    LINK SLED Knee System Tibial Component Recall for Aseptic Loosening Risk

    Linkbio Corp. is recalling the LINK SLED Knee System tibial component due to risk of aseptic loosening and wear. The recall addresses concerns about suboptimal implant positioning or inadequate cementing technique that could lead to early revision surgery.

    Product
    LINK SLED Knee System: ENDO MODEL SLED TIBIAL COMP 9 MM X 45 MM Item Number: 15-2030/02
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1559-2023·2023-05-10

    Laboratory automation module firmware may cause sample misidentification

    A firmware bug in Inpeco laboratory automation modules may cause sample misidentification, leading to incorrect electrolyte test results and potential treatment errors.

    Product
    Input Output Module (IOM) FLX-201-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: FLX-201-00, APT-201-00, APT-253-00 ACP-201-00, FLX-201-10, FLX-253-10, FLX-253-11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1563-2023·2023-05-10

    Laboratory automation system firmware recalled for sample mis-identification

    Inpeco is recalling Alinity h laboratory automation system firmware that may mis-identify samples, causing incorrect electrolyte test results that could lead to improper patient treatment.

    Product
    Alinity h Interface Module (HSQ)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: FLX-274-20
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1535-2023·2023-05-10

    Knee Implant Recalled for Inadequate Surgical Technique Guidance

    Linkbio is recalling 15 LINK SLED Knee Systems due to potential aseptic loosening and wear from suboptimal implant positioning or inadequate cementing during surgery. Updated surgical technique training is required.

    Product
    LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 55 MM Item Number: 15-2030/12
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1562-2023·2023-05-10

    Laboratory Automation Module Firmware May Cause Sample Misidentification

    Vesmatic Cube 80 laboratory automation system firmware can incorrectly identify patient samples, potentially leading to wrong test results and inappropriate treatment. Affected systems include FlexLab, Accelerator a3600, and Aptio Automation units.

    Product
    Vesmatic Cube 80 Interface Module (VMC)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: 72747000.A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1530-2023·2023-05-10

    LINK SLED Knee Implant Recall: Risk of Early Loosening and Revision Surgery

    Linkbio Corp. is recalling 14 LINK SLED Knee implants due to risk of aseptic loosening and increased wear caused by improper surgical technique. The implants may fail earlier than expected, requiring revision surgery.

    Product
    LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 9 MM X 50 MM Item Number: 15-2030/06
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1545-2023·2023-05-10

    LINK SLED Knee Implant Surgical Technique Update Required

    The LINK SLED Knee System requires updated surgical technique training due to risks of aseptic loosening and implant wear when improperly positioned or cemented. The manufacturer is issuing reinforced surgical guidelines and training to prevent unsatisfactory outcomes.

    Product
    LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 45 MM Item Number: 15-2230/04
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1537-2023·2023-05-10

    LINK SLED Knee System Tibial Implant Aseptic Loosening Risk

    The LINK SLED Knee System tibial implant may experience early aseptic loosening if not positioned or cemented properly during surgery. Linkbio recommends updated surgical technique training for optimal implant placement.

    Product
    LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 50 MM Item Number: 15-2030/14
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1557-2023·2023-05-10

    VITROS 5600 Integrated System MicroTip Pack Opener Assembly Defect

    Refurbished VITROS 5600 diagnostic systems may have a defective MicroTip Pack Opener Assembly that fails to properly remove or replace pack caps, potentially causing delayed test results. Ortho-Clinical Diagnostics is recalling 1,148 units distributed nationwide and internationally.

    Product
    VITROS 5600 Integrated System - Refurbished . For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides, VITROS Chemistry Products MicroTip Reagents and VITROS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1482-2023·2023-05-10

    Hill-Rom Pro+ Hospital Mattress Covers Recalled for Delamination Risk

    Baxter is recalling Hill-Rom pro+ mattress covers that may delaminate, allowing fluid to seep into the mattress. No injuries have been reported.

    Product
    Hill-Rom pro+ mattress, product codes (REF): a) 20877002S, b) 20877003S, c) 20877004S, d) 20877007S, e) 20877008S, f) 21649301S, g) 21649401S, h) 21649402S, i) P006800A01, j) P006800A02, k) P3255A01, l) P3255A02, m) P3255A03, n) P3255ARENT01, o) P7923A01, p) P7923A02, q) P7923A0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1556-2023·2023-05-10

    VITROS 5600 system pack opener assembly may not function properly

    The MicroTip Pack Opener Assembly on VITROS 5600 systems may fail to remove or replace pack caps properly, making packs unusable and delaying clinical test results. Approximately 4,895 units were distributed.

    Product
    VITROS 5600 Integrated System- For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnosti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1558-2023·2023-05-10

    DeVilbiss Healthcare 1025 Series Oxygen Concentrator Instruction Manual Update

    DeVilbiss Healthcare is updating the instruction manual for its 1025 Series Oxygen Concentrator to comply with IEC-60101-1 standard labeling requirements. This recall affects 143,397 units distributed nationwide and worldwide.

    Product
    DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1529-2023·2023-05-10

    Knee implant system amended surgical technique and training guidance

    Linkbio Corp. is issuing amended surgical technique guidance for its knee implant system to prevent early loosening and wear caused by improper positioning or inadequate cementing.

    Product
    LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 45 MM Item Number: 15-2030/04
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1506-2023·2023-05-10

    DERMLITE DL4W Medical Device Recalled for Serial Number Labeling Discrepancy

    DermLite LLC is recalling DERMLITE DL4W diagnostic devices due to incorrect package labeling. The serial number on the package differs from the serial number on the product itself.

    Product
    DERMLITE DL4W, REF: DL4W, Rx Only MD, CE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1555-2023·2023-05-10

    VITROS XT 7600 Analyzer Pack Opener May Not Remove Reagent Pack Caps

    The MicroTip Pack Opener Assembly in VITROS XT 7600 laboratory analyzers may fail to properly remove or replace reagent pack caps, potentially causing unusable packs and delayed test results. Approximately 2,001 affected units were distributed nationwide and internationally.

    Product
    VITROS XT 7600 Integrated System - For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagn
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1429-2023·2023-05-03

    Hamilton HAMILTON-C6 Ventilator Software Error Disables Patient Input Monitoring

    The HAMILTON-C6 ventilator (103 units) has a software error that disables patient input monitoring when switching to adaptive ventilation modes with a connected controller or humidifier. The device will alarm but cannot respond to patient inputs.

    Product
    HAMILTON-C6, REF: 160021
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1431-2023·2023-05-03

    Surgical Convenience Kits Recalled for Separating Light Handle Covers

    ROi CPS LLC is recalling sterile surgical convenience kits because light handle covers may separate and fall off during use. The recall affects 278 kits distributed in Florida and Missouri.

    Product
    Sterile surgical convenience kits: 1. regard Item Number: 880405003, GS01011C - General Laparoscopy; 2. regard Item Number: 880424004, GS01031D - Thoracic.
    Category
    Medical Device
    Distribution
    Distributed nationwide