The Recall Desk

Hazard

Sterility Breach recalls

473 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
473
Critical
0
Severe
27
Most recent
2026-09-23

Of the 473 sterility breach recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 27 (6%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all sterility breach recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

401–425 of 473

  • HighFDA (Devices)·Z-1195-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 260 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 H965600338021, REF/Catalog No. 60033802, 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-1203-2015·2015-03-04

    Navilyst NAMIC Convenience Kit Recalled for Potential Sterility Breach

    Navilyst Medical is recalling 20 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 H965601955411, REF/Catalog No. 60195541, 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-1190-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 61 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 H749602322341, REF/Catalog No. 60232234, 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-1186-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 33 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 H749602000571, REF/Catalog No. 60200057, 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-1159-2015·2015-03-04

    Navilyst NAMIC Convenience Kits Recalled for Potential Sterility Breach

    Navilyst Medical is recalling 161 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 H7496005216131, REF/Catalog No. 600521613, 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-1197-2015·2015-03-04

    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 risk of infection.

    Product
    NAMIC Convenience Kit, 3V MANIFOLD KIT, UPN H965601011621, REF/Catalog No. 60101162, 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-1200-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 7 units of NAMIC Convenience Kits because expiration dating is not fully supported by testing, posing a potential sterility breach and infection risk.

    Product
    NAMIC Convenience Kit, 3V WMMII KIT, UPN H965601852521, REF/Catalog No. 60185252, 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-1149-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 19 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, 5 VALVE MANIFOLD KIT, UPN H749600105121, REF/Catalog No. 60010512, 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-1181-2015·2015-03-04

    Navilyst NAMIC Convenience Kit Recalled for Potential Sterility Breach

    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 H749601827221, REF/Catalog No. 60182722, 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-1188-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 17 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 H749602207461, REF/Catalog No. 60220746, 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-1164-2015·2015-03-04

    Navilyst NAMIC Convenience Kit Recalled Due to Sterility Concerns

    Navilyst Medical is recalling 602 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, UPN H749600709971, REF/Catalog No. 60070997, 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-1163-2015·2015-03-04

    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 risk of infection.

    Product
    NAMIC Convenience Kit, LEFT HEART KIT, UPN H7496007057101, REF/Catalog No. 600705710, 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-1176-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 22 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, RADIOLOGY KIT, UPN H749601506921, REF/Catalog No. 60150692, 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-1156-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 927 NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in sterility breach and increased infection risk.

    Product
    NAMIC Convenience Kit, 3 VALVE MANIFOLD KIT, UPN H749600411611, REF/Catalog No. 60041161, 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-1207-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 133 NAMIC Convenience Kits because expiration dating is not fully supported by shelf life testing, which may result in a sterility breach and increased risk of infection.

    Product
    NAMIC Convenience Kit, RADIOLOGY KIT, UPN H7496002072111, REF/Catalog No. 600207211, 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 Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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