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.

426–450 of 473

  • 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-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-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
  • HighFDA (Devices)·Z-1202-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 74 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 H965601931651, REF/Catalog No. 60193165, 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-1177-2015·2015-03-04

    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, UPN H7496016046121, REF/Catalog No. 601604612, 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-1161-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 30 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, RADIOLOGY KIT, UPN H749600617521, REF/Catalog No. 60061752, 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-1166-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Left Heart Cath Kits Due to Sterility Concerns

    Navilyst Medical is recalling 62 units of NAMIC Left Heart Cath Kits because expiration dating is not fully supported by shelf life testing, which may result in a sterility breach.

    Product
    NAMIC Convenience Kit, LEFT HEART CATH KIT, UPN H7496010018151, REF/Catalog No. 601001815, 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1199-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling specific lots 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 H965601206511, REF/Catalog No. 60120651, 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-1160-2015·2015-03-04

    Navilyst NAMIC Convenience Kit Recall Due to Sterility Risk

    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, LEFT HEART, UPN H7496006044121, REF/Catalog No. 600604412, 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1152-2015·2015-03-04

    Navilyst NAMIC Convenience Kits 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, LEFT HEART KIT, UPN H749600309351, REF/Catalog No. 60030935, 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-1148-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 15 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, LEFT HEART KIT, UPN H7496001001111, REF/Catalog No. 600100111, 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-1189-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 2,502 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 H749602301481, REF/Catalog No. 60230148, 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-1593-2014·2014-11-26

    Medtronic Recalls Sterile Percutaneous Pins Due to Sterility Control Issues

    Medtronic Navigation is recalling 26,674 sterile percutaneous pins because returned devices may not have been properly examined for damage to ensure sterility.

    Product
    PIN, 9733236, 150MM, STERILE, PERC REF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1587-2014·2014-11-26

    Medtronic Recalls Thoracic Tactile Probes Due to Sterility Control Issues

    Medtronic Navigation is recalling 26,674 thoracic tactile probe kits because returned devices may not have been properly examined for damage to ensure sterility.

    Product
    KIT, 9731427, THORACIC TACTILE PROBES
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2636-2014·2014-09-24

    Volcano TrakBack II Disposable Pullback Device Recalled for Sterility Concerns

    Volcano Corporation is recalling TrakBack II Disposable Pullback Devices because internal testing identified a potential breach to the sterile barrier that may impact product sterility.

    Product
    Volcano TrakBack II Disposable Pullback Device; Sterile and nonpyrogenic; Single Use. TrakBack II is used to move the catheter steadily and precisely, allowing uniform collection of imaging data.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2046-2014·2014-07-23

    Smith & Nephew Recalls SUTUREFIX Ultra Anchor XL Due to Sterility Breach

    Smith & Nephew is recalling 136 units of SUTUREFIX Ultra Anchor XL devices because a breach in the sterile barrier compromised the device's sterility.

    Product
    SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Cobraid Suture Product Code: 72203842 Fastener, fixation, nondegradable, soft tissue
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2047-2014·2014-07-23

    Smith & Nephew Recalls SUTUREFIX Ultra S Devices Due to Sterility Breach

    Smith & Nephew is recalling 907 units of SUTUREFIX Ultra S devices because a breach in the sterile barrier compromises the device's sterility.

    Product
    SUTUREFIX Ultra S with 1 #2 Ultrabraid (blue) Product Code: 72203852 Fastener, fixation, nondegradable, soft tissue
    Category
    Medical Device
    Distribution
    Distributed nationwide