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-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-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-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-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-1498-2023·2023-05-10

    Angiography System C-Arm Positioning Malfunction May Cause Patient Injury

    Siemens ARTIS pheno angiography systems may misposition the C-arm by 5-10 millimeters when using the reference image positioning function, risking patient and staff crushing injuries. The device may also display inaccurate imaging overlays, potentially causing vessel perforation.

    Product
    ARTIS pheno systems with a Siemens Healthineers table or Trumpf/MAQUET table (OEM)- Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Model: 10849000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1536-2023·2023-05-10

    Knee Implant System Recalled for Premature Loosening and Wear Risk

    Linkbio Corp. is recalling LINK SLED Knee System implants that may loosen or wear prematurely due to improper surgical positioning or cementing, potentially requiring revision surgery. Updated surgical technique guidance is being provided.

    Product
    LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 45 MM Item Number: 15-2030/13
    Category
    Medical Device
    Distribution
    2 states
  • 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-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-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-1478-2023·2023-05-10

    FDA Recalls injeTAK Adjustable Tip Needles for Damaged Packaging

    Labories Medical Technologies is recalling injeTAK Adjustable Tip Needles because packaging damage may compromise the sterile barrier, creating a risk of contamination.

    Product
    injeTAK Adjustable Tip Needles Needle Sheath diameter 6Fr with 35-50cm in length Stainless-stell needle cannula is 25 gauge
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1512-2023·2023-05-10

    Knee Implant Recall Due to Risk of Aseptic Loosening and Wear

    Linkbio Corp. is recalling 13 units of the LINK SLED knee implant component due to risk of early aseptic loosening or increased wear caused by suboptimal surgical positioning or inadequate cementing technique. Amended surgical technique guidance has been provided.

    Product
    LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 45MM Item Number: 15-2028/02
    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-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-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-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-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-1544-2023·2023-05-10

    Knee Implant Component Recalled for Surgical Positioning and Cementing Guidance

    FDA is updating surgical instructions for the LINK SLED Knee System to address early aseptic loosening and increased wear from suboptimal positioning or inadequate cementing technique. Updated training aims to prevent implant failure and unexpected revision surgery.

    Product
    LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 45 MM Item Number: 15-2230/03
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1519-2023·2023-05-10

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

    Linkbio Corp. is recalling the LINK SLED Knee System ALL POLY TIBIAL COMPONENT due to risk of early aseptic loosening or increased wear from suboptimal surgical placement or cementing, which may require early revision surgery.

    Product
    LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 55MM Item Number: 15-2028/09
    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
  • 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-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-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-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-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