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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9501–9525 of 13717

  • HighFDA (Devices)·Z-1539-2023·2023-05-10

    Orthopedic knee implant system recalled due to early loosening risk

    Linkbio Corp. is recalling 5 units of the LINK SLED Knee System due to risk of early aseptic loosening or increased wear that could require earlier surgical revision. The recall addresses training and surgical technique to prevent implant failure.

    Product
    LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, SMALL Item Number: 15-2220/40
    Category
    Medical Device
    Distribution
    2 states
  • 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-1504-2023·2023-05-10

    Siemens Atellica cortisol kits recalled for negative bias in urine testing

    Siemens Healthcare Diagnostics recalls 34,746 Atellica IM Cortisol diagnostic kits due to negative bias in urine test results, which may produce inaccurately low cortisol measurements.

    Product
    Atellica IM Cortisol 50T (Material Number 10995538), 250T (Material Number 10995537), and REF 250T (Material Number 11206248). In vitro diagnostic use in the quantitative determination of cortisol in human serum, plasma (EDTA and lithium heparin), and urine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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-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-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-1524-2023·2023-05-10

    LINK SLED Knee System tibial component subject to early loosening recall

    Linkbio Corp. is recalling the LINK SLED Knee System tibial component (15 units) due to risk of early loosening and increased wear from inadequate surgical technique, potentially requiring earlier-than-expected revision surgery.

    Product
    LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9X58MM Item Number: 15-2028/14
    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-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-1503-2023·2023-05-10

    FDA Class II Recall: Ultraview SL Command Module Monitoring Alarms May Fail

    Spacelabs Healthcare is recalling 1,088 Ultraview SL Command Module units due to a software defect. The devices may fail to display alarms or waveforms when parameter processing is suspended, potentially causing clinicians to miss critical patient events.

    Product
    Ultraview SL (UVSL) Command Module, Model 91496
    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-1554-2023·2023-05-10

    LINK SLED Knee System tibial implant recalled for aseptic loosening

    Linkbio Corp. recalls LINK SLED Knee System tibial component due to risk of aseptic loosening and implant wear from improper surgical technique, potentially requiring revision surgery.

    Product
    LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 55 MM Item Number: 15-2230/15
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1538-2023·2023-05-10

    LINK SLED Knee Implant Component Recalled for Aseptic Loosening Risk

    The LINK SLED Knee System tibial component is being recalled due to risk of aseptic loosening caused by improper implant positioning or cementing technique, which could lead to early implant failure requiring revision surgery.

    Product
    LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 55 MM Item Number: 15-2030/15
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1525-2023·2023-05-10

    LINK SLED Knee Implant Component Recall for Aseptic Loosening Risk

    Linkbio Corp. is recalling the LINK SLED Knee System's all-poly tibial component due to risk of early aseptic loosening and increased wear from suboptimal implant positioning or inadequate cementing during surgery.

    Product
    LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11X58MM Item Number: 15-2028/15
    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-1507-2023·2023-05-10

    Knee implant component recalled for risk of premature loosening and wear

    Linkbio Corp. is recalling 14 units of LINK SLED Knee System knee implant components due to risk of early loosening and wear caused by suboptimal implant positioning or inadequate cementing technique. Affected patients should contact their surgeon.

    Product
    LINK SLED Knee System: ENDO SLED KNEE FEM COMP, SMALL Item Number: 15-2020/40
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1560-2023·2023-05-10

    Laboratory Automation System Firmware May Misassociate Patient Samples

    Inpeco laboratory automation systems have a firmware defect that may cause sample ID mis-association, leading to incorrect test results for electrolyte measurements. Potential consequences include abnormal treatment decisions and serious health complications.

    Product
    Storage and Retrieval Module (SRM)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: ACP-207-00, ACP-207-01, ACP-230-00, ACP-230-01 APT-207-00, APT-207-01, APT-230-00, APT-230-01 F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1505-2023·2023-05-10

    Siemens ADVIA Centaur Cortisol Diagnostic Kits Recalled for Negative Measurement Bias

    Siemens Healthcare Diagnostics is recalling 18,961 ADVIA Centaur Cortisol diagnostic kits due to negative bias in urine samples causing intermittently low test results that could affect clinical diagnosis.

    Product
    ADVIA Centaur Cortisol 50T (Material Number 10994924), ADVIA Centaur Cortisol 250T (Material Number 10994926), and ADVIA Centaur Cortisol REF 250T (Material Number 10994927). In vitro diagnostic use in the quantitative determination of cortisol in human serum, plasma (EDTA and li
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1520-2023·2023-05-10

    LINK SLED Knee Implant Component Recalled for Early Aseptic Loosening Risk

    Linkbio Corp. is recalling 13 units of the LINK SLED Knee Implant All Poly Tibial Component due to risk of early aseptic loosening from suboptimal surgical positioning or inadequate cementing technique. Updated surgical technique guidance is being provided to prevent premature implant failure.

    Product
    LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 55MM Item Number: 15-2028/10
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1521-2023·2023-05-10

    Linkbio Knee Implant Recalled for Aseptic Loosening Risk

    Linkbio Corp. is recalling 15 LINK SLED Knee System implants due to risk of aseptic loosening and wear from improper surgical technique. The company is providing amended surgical guidance and training to prevent implant failure.

    Product
    LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 55MM Item Number: 15-2028/11
    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-1514-2023·2023-05-10

    Knee implant recalled due to early aseptic loosening risk from surgical technique

    LINK SLED Knee System tibial components are being recalled due to risk of early aseptic loosening and increased wear from suboptimal implant positioning or inadequate cementing technique. Surgical technique guidance is being issued.

    Product
    LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13MM X 45MM Item Number: 15-2028/04
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1476-2023·2023-05-10

    Steris Light Handle Covers May Detach During Surgical Use

    Steris Corporation is recalling 263,280 surgical light handle covers worldwide because they may separate from the light handle during procedures, potentially compromising the sterile field.

    Product
    Steris Lighting and Visualization Systems, Sterile Light handle Cover LB44 -Sterilizable consumables (disposable, single use) used to drape the lighthandle of STERIS surgical lighting systems for the purpose of maintaining a sterile surgical environment. REF: LB44
    Category
    Medical Device
    Distribution
    Distributed nationwide