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 the agency’s own highest classification or reported deaths or serious injuries, 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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33451–33475 of 40325

  • HighFDA (Devices)·Z-1157-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 16 NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased risk of infection.

    Product
    NAMIC Convenience Kit, MOBILE CATH LAB KIT, UPN H749600419211, REF/Catalog No. 60041921, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1194-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 2 units of NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased infection risk.

    Product
    NAMIC Convenience Kit, ANGIO DOUBLE SPIKE KIT, UPN H9656003028111, REF/Catalog No. 600302811, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136683. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1185-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 2 units of NAMIC Convenience Kits because expiration dating is not fully supported by shelf life testing, posing a risk of sterility breach and infection.

    Product
    NAMIC Convenience Kit, UPN H749601907851, REF/Catalog No. 60190785, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1205-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 3 units of NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased risk of infection.

    Product
    NAMIC Convenience Kit, LEFT HEART, POTENTIAL REVISION TO 600604412, UPN H965PK0604436S1, REF/Catalog No. PK0604436S, STERILE, Rx ONLY - For single use only. --- Device Listing Number D136588 NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1178-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 2 units of NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased risk of infection.

    Product
    NAMIC Convenience Kit, LEFT HEART KIT, UPN H749601605351, REF/Catalog No. 60160535, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1206-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased infection risk.

    Product
    NAMIC Convenience Kit, UPN H965PK193168S1, REF/Catalog No. PK193168S, STERILE, Rx ONLY ---For single use only. Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1150-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 32 units of NAMIC Convenience Kits because expiration dating is not fully supported by shelf life testing, which may result in a sterility breach and increased infection risk.

    Product
    NAMIC Convenience Kit, NEURO ANGIO KIT, UPN H749600202361, REF/Catalog No. 60020236, STERILE, Rx ONLY --- For single use only. Device Listing Number D136683. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1175-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 5 units of NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased infection risk.

    Product
    NAMIC Convenience Kit, LEFT HEART KIT, UPN H749601506721, REF/Catalog No. 60150672, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1151-2015·2015-03-04

    Navilyst NAMIC Convenience Kits Recalled Due to Sterility Concerns

    Navilyst Medical is recalling 4 units of NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased infection risk.

    Product
    NAMIC Convenience Kit, UPN H749600203741, REF/Catalog No. 60020374, STERILE, Rx ONLY --- For single use only. Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1187-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 238 NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased infection risk.

    Product
    NAMIC Convenience Kit, UPN H749602001451, REF/Catalog No. 60200145, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1201-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 70 NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased risk of infection.

    Product
    NAMIC Convenience Kit, PTCA KIT, UPN H9656019110161, REF/Catalog No. 601911016, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1184-2015·2015-03-04

    Navilyst NAMIC Convenience Kit Recalled Due to Sterility Concerns

    Navilyst Medical is recalling NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased infection risk.

    Product
    NAMIC Convenience Kit, UPN H749601904231, REF/Catalog No. 60190423, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1155-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 489 NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased infection risk.

    Product
    NAMIC Convenience Kit, LEFT HEART KIT, UPN H749600407061, REF/Catalog No. 60040706, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1144-2015·2015-03-04

    Spacelabs XPREZZON Bedside Monitors Recalled for Boot Failure

    Spacelabs Healthcare is recalling XPREZZON Bedside Monitors because they may fail to boot up or reset to factory defaults after power on.

    Product
    Spacelabs Healthcare XPREZZON Bedside Monitor, Model 91393. The Spacelabs Healthcare XPREZZON Bedside Monitor passively displays data generated by Spacelabs parameter modules, Flexport interfaces, and other Spacelabs SDLG based products as waveform and numeric displays, trends…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1182-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 11 NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased infection risk.

    Product
    NAMIC Convenience Kit, HOPKINS LEFT HEART, UPN H749601836621, REF/Catalog No. 60183662, STERILE, Rx ONLY ---- For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1158-2015·2015-03-04

    Navilyst NAMIC Convenience Kits Recalled for Sterility Concerns

    Navilyst Medical is recalling 454 NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased infection risk.

    Product
    NAMIC Convenience Kit, LEFT HEART KIT, UPN H7496005001131, REF/Catalog No. 600500113, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1154-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 438 NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased infection risk.

    Product
    NAMIC Convenience Kit, 3 VALVE KIT CARDIOVASCULAR PROCEDURE KIT, UPN H749600403131, REF/Catalog No. 60040313, STERILE, Rx ONLY --- --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1162-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 562 NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased risk of infection.

    Product
    NAMIC Convenience Kit, LEFT HEART KIT, UPN H749600618011, REF/Catalog No. 60061801, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1174-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased infection risk.

    Product
    NAMIC Convenience Kit, UPN H749601399921, REF/Catalog No. 60139992, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1136-2015·2015-03-04

    Zimmer Metasul Femoral Head Recalled for Potential Sterile Tray Compromise

    Zimmer GmbH is recalling 16 Metasul Femoral Heads due to potential sterile tray compromise, which could lead to periprosthetic infection if undetected.

    Product
    Metasul Femoral Head - indicated for total hip arthroplasty for treatment of patient conditions of non-inflammatory degenerative joint disease.
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-1192-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 2 units of NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased risk of infection.

    Product
    NAMIC Convenience Kit, LEFT HEART KIT, UPN H965600125911, REF/Catalog No. 60012591, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1153-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 136 NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased risk of infection.

    Product
    NAMIC Convenience Kit, UPN H749600329421, REF/Catalog No. 60032942, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1170-2015·2015-03-04

    Navilyst NAMIC Convenience Kits Recalled for Sterility Concerns

    Navilyst Medical is recalling 411 NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased infection risk.

    Product
    NAMIC Convenience Kit, UPN H749601314811, REF/Catalog No. 60131481, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide