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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8151–8175 of 27441

  • HighFDA (Devices)·Z-1577-2023·2023-05-17

    STA Compact Max analyzer firmware bug causes inaccurate test results

    A firmware bug in Diagnostica Stago's STA Compact Max analyzer causes intermittent shortened coagulation times and frequent technical errors that produce inaccurate lab test results. Five units were distributed to clinical laboratories nationwide.

    Product
    STA Compact Max fully automatic clinical analyzer, Reference Numbers 58602 and 58612
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1576-2023·2023-05-17

    STA Compact Analyzer Firmware Bug Causes Inaccurate Test Results

    Diagnostica Stago is recalling STA Compact Analyzers due to a firmware bug causing intermittent shortened coagulation times and increased technical errors. No illnesses or injuries have been reported.

    Product
    STA Compact Automated Multi-Parametric Analyzer, Reference Numbers 58602 and 58612
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1574-2023·2023-05-17

    Medtronic Spinal Distractor Rack Recalled for Manufacturing Defect

    Medtronic is recalling Distractor Rack devices used in spinal surgery due to manufacturing defects that may prevent proper device operation. Two lot numbers are affected and were distributed to facilities in Indiana, Connecticut, and Nebraska.

    Product
    Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set, Loaner Kit Number SPS03139; for use in spinal surgery
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1569-2023·2023-05-17

    Aesculap Caiman Articulating Surgical Device Recalled for Loose Spring

    Aesculap Caiman Articulating electrosurgical devices are being recalled because a spring may become loose and fall out during surgery, potentially entering the patient's body.

    Product
    Aesculap Caiman Articulating D5/360MM - An electrosurgical cutting and coagulation device for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery, and may in addition be intended for open surgery. Product Code: PL771SU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1570-2023·2023-05-17

    M-Close Kit suturing apparatus recalled due to plastic housing fracture risk

    New Wave Endo-Surgical is recalling the M-Close Kit surgical suturing apparatus because the plastic housing may fracture. The recall affects 295 units distributed in Florida, Massachusetts, and Georgia.

    Product
    M-Close Kit, REF 27-101; a disposable, ligature passing, suturing apparatus and needle guide for the abdominal wall
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1578-2023·2023-05-17

    Sheath Introducer Kit with Incorrect Needle Size Recalled

    Merit Medical Systems is recalling COBRA-OS Sheath Introducer Kits due to an incorrect needle size that may affect proper insertion during medical procedures.

    Product
    COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E01P2, Sterile EO, Single Use, RX Only, 5 Units
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1564-2023·2023-05-17

    Bard Mission Biopsy Instrument Kit cannula and needle incompatibility

    Bard Mission Disposable Biopsy Instrument Kit has an incompatibility defect where the cannula is oversized relative to the needle, preventing proper insertion and tissue access. This could cause procedure delays and insufficient tissue collection.

    Product
    Bard Mission Disposable Core Biopsy Instrument Kit: REF: 2010MSK, 20G x 10CM; REF: 2016MSK, 20G x 16CM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1573-2023·2023-05-17

    Laboratory Management Software May Display Incorrect Slide Labels

    TDHisto/Cyto laboratory management software may display incorrect information on slide labels in specific use cases. The FDA has issued a Class II recall affecting laboratories nationwide in California.

    Product
    TDHisto/Cyto - A software product used for managing medical information in the field of laboratories performing histology, nongynecological and gynecological cytology and autopsy activities.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1571-2023·2023-05-17

    PDS Plus Antibacterial Suture Potential Breakage During Intraoperative Use

    Ethicon recalled 1,656 units of PDS Plus Antibacterial Suture due to potential breakage during surgery, which could compromise tissue approximation. The affected lot was distributed to the United Kingdom, Ireland, and Turkey.

    Product
    PDS¿ Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3-0(M2) S/A PC-25 PRIME. Intended for use in general soft tissue approximation, including use in pediatric cardiovascular tissue. Product Code: PDP9625H
    Category
    Medical Device
    Distribution
    0 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-1533-2023·2023-05-10

    LINK SLED Knee System Recalled for Aseptic Loosening and Implant Wear

    Linkbio Corp. is recalling 12 units of the LINK SLED Knee System due to risk of implant loosening and wear that could require revision surgery sooner than expected.

    Product
    LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 9 MM X 55 MM Item Number: 15-2030/10
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1561-2023·2023-05-10

    Laboratory Automation System Firmware May Misidentify Patient Samples

    Inpeco laboratory automation systems' firmware can misassociate patient samples, potentially leading to incorrect electrolyte test results. The defect is rare but could cause serious medical consequences if results are misidentified or delayed.

    Product
    PVT Interface Module (PVT)-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-1473-2023·2023-05-10

    OttLite UVC Disinfecting Wand Emits Excessive Ultraviolet Radiation

    OttLite Rechargeable UVC Disinfecting Wand model UV10002M emits excessive ultraviolet radiation above safe limits. Approximately 7,376 units were distributed nationwide.

    Product
    OttLite Rechargeable UVC Disinfecting Wand
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1518-2023·2023-05-10

    LINK SLED Knee Implant Component Recalled Due to Early Loosening Risk

    FDA recalls LINK SLED Knee System tibial components due to risk of aseptic loosening and premature wear. Patients may require revision surgery.

    Product
    LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13MM X 50MM Item Number: 15-2028/08
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1541-2023·2023-05-10

    LINK SLED Knee System implants recalled for early loosening risk

    Linkbio Corp. recalls 7 LINK SLED knee implants due to risk of early aseptic loosening and increased wear caused by suboptimal surgical technique. Affected units may require earlier-than-expected revision surgery.

    Product
    LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, MEDIUM Item Number: 15-2220/52
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1540-2023·2023-05-10

    LINK SLED Knee System recalls issued over aseptic loosening risk

    Linkbio Corp. is recalling LINK SLED Knee System knee components due to risk of early aseptic loosening or increased wear. The company is issuing updated surgical technique guidance to address suboptimal implant positioning and cementing techniques.

    Product
    LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, MEDIUM SMALL Item Number: 15-2220/46
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1501-2023·2023-05-10

    Medical Image Viewer May Mismatch Patient Study Records

    GE Healthcare's Centricity Universal Viewer can mismatch patient information when correcting patient or study data, affecting 329 units distributed worldwide.

    Product
    Centricity Universal Viewer, Centricity Universal Viewer 6.0, Model/Catalog Numbers: a) 2088026-003, b) 2088026-026, c) 2088026-032, d) 2088026-043, e) 2088026-044, f) 2088026-115, g) 2088026-132, h) 2088026-306, i) 2088026-308, j) 2088026-406, k) 2088026-506, l) 20
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1513-2023·2023-05-10

    Knee Implant System Component Recalled Due to Aseptic Loosening Risk

    Linkbio Corp. is recalling 13 units of the LINK SLED Knee System tibial component due to risk of aseptic loosening and increased wear. These risks arise from improper surgical positioning or inadequate cementing technique during implantation.

    Product
    LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 45MM Item Number: 15-2028/03
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1497-2023·2023-05-10

    CryoTreQ Aa ophthalmic instrument recalled for risk of sudden disassembly

    Beaver Visitec is recalling the CryoTreQ Aa ophthalmic surgical instrument due to risk of sudden disassembly during use. Device disassembly during cryosurgery could cause permanent vision impairment.

    Product
    CryoTreQ- Aa disposable handheld instrument intended for ophthalmic surgery. It creates a tip at cryogenic temperatures by evaporation of N2O that can be utilized to perform cryotherapy based on the destruction of tissue by extreme cold to locally perform cryocoagulation on tissu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1508-2023·2023-05-10

    Linkbio LINK SLED Knee implant system recalled for surgical technique requirements

    Linkbio Corp. recalls LINK SLED Knee System implants due to risk of early loosening and increased wear caused by improper surgical technique. Updated training and labeling have been issued.

    Product
    LINK SLED Knee System: ENDO SLED KNEE FEM COMP, MEDIUM SMALL Item Number: 15-2020/46
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1477-2023·2023-05-10

    Philips ProxiDiagnost N90 radiography systems recalled due to cable damage

    Philips is recalling certain ProxiDiagnost N90 radiography systems due to a cable under the table that may break. A broken cable could prevent users from tilting the table or engaging braking.

    Product
    Philips ProxiDiagnost N90 1.0 (Model 706100) and ProxiDiagnost N90 1.1 (Model 706110)- A multi-functional general radiography and fluoroscopy (R/F) system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1531-2023·2023-05-10

    LINK SLED Knee Implant Recall Due to Loosening and Wear Risks

    Linkbio Corp. is recalling 14 units of LINK SLED Knee System implants due to risk of early aseptic loosening or wear from suboptimal positioning or inadequate cementing. Updated surgical technique training is being issued.

    Product
    LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 11 MM X 50 MM Item Number: 15-2030/07
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1523-2023·2023-05-10

    LINK SLED Knee System tibial component recall due to implant positioning and cementing concerns

    Linkbio Corp. is recalling LINK SLED Knee System tibial components due to risk of early loosening or increased wear caused by suboptimal implant positioning or inadequate cementing technique. Surgeons are being directed to update their technique and receive additional training.

    Product
    LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 58MM Item Number: 15-2028/13
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1550-2023·2023-05-10

    LINK SLED Knee Implant Recall for Aseptic Loosening Risk

    The LINK SLED Knee System POREX ENDO tibial implant is recalled due to risk of early aseptic loosening or increased wear from suboptimal positioning or inadequate cementing. Affected patients may require early revision surgery.

    Product
    LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM Item Number: 15-2230/11
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1517-2023·2023-05-10

    LINK SLED Knee Implant Component Recalled Due to Loosening

    Linkbio Corp. recalls the LINK SLED Knee Component due to risk of early aseptic loosening and implant wear. The issue stems from suboptimal implant positioning or inadequate cementing technique.

    Product
    LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 50MM Item Number: 15-2028/07
    Category
    Medical Device
    Distribution
    2 states