The Recall Desk

Hazard

Sterile Breach recalls

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

What the numbers show

Total
32
Critical
0
Severe
2
Most recent
2026-07-08

Of the 32 sterile 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 2 (6%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all sterile 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.

26–32 of 32

  • ModerateFDA (Devices)·Z-2384-2015·2015-08-26

    C.R. Bard Recalls Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters

    C.R. Bard is recalling 14,310 units of Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters due to a potential breach of the sterile barrier packaging.

    Product
    Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 10 Fr, (30/box), Product Code 51610. Intermittent catheter.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2386-2015·2015-08-26

    C.R. Bard Recalls Magic3 Female Intermittent Urinary Catheters

    C.R. Bard is recalling 37,686 Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters due to a potential breach of the sterile barrier packaging.

    Product
    Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 14 Fr, (30/box), Product Code 51614. Intermittent catheter.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2385-2015·2015-08-26

    C.R. Bard Recalls Magic3 Intermittent Urinary Catheters Due to Sterile Breach

    C.R. Bard is recalling 91,140 Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters due to a potential breach of the sterile barrier packaging.

    Product
    Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 12 Fr, (30/box), Product Code 51612. Intermittent catheter.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2388-2015·2015-08-26

    C.R. Bard Recalls Magic3 Female Intermittent Urinary Catheters for Sterile Breach

    C.R. Bard is recalling 534,972 Magic3 Female Intermittent Urinary Catheters due to a potential breach of the sterile barrier packaging.

    Product
    Magic3 Hydrophilic-coated Female Intermittent Urinary Catheter 14 Fr in the Insertion Supply Kit, Product Code 51614S. Intermittent catheter.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1692-2014·2014-06-11

    Bard Ventralight ST Mesh Recall Due to Potential Sterile Pouch Seal Issues

    Davol, Inc. is recalling specific lots of Bard Ventralight ST Mesh because the sterile pouch holding the inflation assembly may have a weak seal or be open.

    Product
    Bard¿ Ventralight" ST Mesh with Echo PS" 6"x10" Reorder Number: 5955610 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1625-2014·2014-05-28

    Hospira Recalls Cystoscopy Sets Due to Potential Sterile Package Seal Defect

    Hospira Inc. is recalling specific cystoscopy and irrigation sets because the Tyvek cover may not be completely sealed, potentially compromising the sterile package.

    Product
    LATEX-FREE; CYSTOSCOPY/IRRIGATION SET; Nonvented, 77 inch (195 cm) for Constant or Intermittent Bladder Irrigation; For Use with Flexible Irrigation Container System; List No. 6544-01; Hospira Product Usage: For Constant or Intermittent Bladder Irrigation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2231-2013·2013-09-25

    Smith & Nephew Recalls TWINFIX Ultra HA Suture Anchors Due to Sterile Breach

    Smith & Nephew is recalling TWINFIX Ultra HA 5.5 mm Suture Anchors because pinholes in primary pouches may breach the sterile barrier.

    Product
    TWINFIX Ultra HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, Blue / Black; Part Number: 72202626 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide