The Recall Desk

Hazard

Sterility Compromise recalls

2,228 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
2,228
Critical
3
Severe
255
Most recent
2026-08-19

Of the 2,228 sterility compromise recalls we have scored against our rubric, 3 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 255 (11%) 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 sterility compromise 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.

1976–2000 of 2228

  • HighFDA (Devices)·Z-2000-2014·2014-07-16

    Vascular Technology Recalls Sterile Doppler Probes Due to Barrier Penetration

    Vascular Technology, Inc. is recalling 34 sterile Doppler probes because the sterile barrier may have been penetrated, potentially rendering the devices unsterile.

    Product
    07-150-12 MIZUHO, MINI, SLIM, STERILE, BOX OF 4, REF 138665 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1956-2014·2014-07-09

    McKesson Medi-Pak Laceration Trays Recalled for Incomplete Sterile Seals

    Medical Action Industries is recalling 474 cases of McKesson Medi-Pak Laceration Trays because some sterile kits may have incomplete seals that could compromise sterility.

    Product
    McKesson Medi-Pak, Laceration Trays with Cotton O.R. Towels, Sterile, Single Use, Latex Free, 20 Each per Case, Rx only, Distributed by: McKesson Medical Surgical, Inc., Richmond, VA 23228
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1952-2014·2014-07-09

    Medical Action Industries Recalls Sterile Suture Sets Due to Seal Defects

    Medical Action Industries is recalling sterile suture sets because incomplete seals may compromise sterility. The recall involves 474 cases distributed across 15 states.

    Product
    Suture Set, Sterile Single Use, Stage Two: Clean Ready to Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1954-2014·2014-07-09

    Medical Action Industries Recalls Max Barrier Kits Due to Seal Defects

    Medical Action Industries is recalling Max Barrier Kits because incomplete seals may compromise sterility. The recall affects 474 cases distributed across 15 states.

    Product
    Max Barrier Kit, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1951-2014·2014-07-09

    Medical Action Industries Recalls Sterile Laceration Kits Due to Seal Defects

    Medical Action Industries is recalling sterile laceration and suture removal kits because incomplete seals may compromise sterility. The recall affects 474 cases distributed across 15 states.

    Product
    Laceration/Suture Removal, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1953-2014·2014-07-09

    Medical Action Industries Recalls Port-A-Cath Trays Due to Seal Defects

    Medical Action Industries is recalling Port-A-Cath Trays because incomplete seals may compromise sterility. The recall affects 474 cases distributed across 15 states.

    Product
    Port-A-Cath Tray, Stage One: Sterile Single Use, Stage Two: Clean Ready to Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1957-2014·2014-07-09

    Medical Action Industries Recalls Laceration Kits Due to Seal Defects

    Medical Action Industries is recalling sterile laceration kits because incomplete seals may compromise sterility. The recall affects 474 cases distributed across 15 states.

    Product
    Laceration Kit: W/Needles, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1955-2014·2014-07-09

    Medical Action Industries Recalls Safety Laceration Kits Due to Seal Defects

    Medical Action Industries is recalling Safety Laceration Kits because incomplete seals may compromise sterility. The recall affects 474 cases distributed across 15 states.

    Product
    Safety Laceration Kit, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1950-2014·2014-07-09

    Medical Action Industries Recalls Sterile Laceration Trays Due to Seal Defects

    Medical Action Industries is recalling sterile laceration trays because incomplete seals may compromise sterility. The recall affects 474 cases distributed across 15 states.

    Product
    Laceration Trays, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc., Arden, NC.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1782-2014·2014-06-18

    Cooper Surgical Tampa Catheter Recalled for Potential Sterility Compromise

    CooperSurgical is recalling 1,180 units of the Tampa Catheter because unsealed pouches may compromise the device's sterility.

    Product
    Cooper Surgical TAMPA CATHETER 5 French 33 cm. Intended for Hysterosonography. Model Number: 61-2005
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1694-2014·2014-06-11

    Bard Ventralight ST Mesh Recall Due to Potential Sterility Compromise

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

    Product
    Bard¿ Ventralight" ST Mesh with Echo PS TM 7"x9" Reorder Number: 5955790 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1690-2014·2014-06-11

    FDA Recalls Bard Ventralight ST Mesh Due to Potential Sterility Compromise

    Davol, Inc. is recalling specific lots of Bard Ventralight ST Mesh because the sterile packaging may be open or have a weak seal, potentially compromising sterility.

    Product
    Bard¿ Ventralight" ST Mesh with Echo PS" 4"x6" Reorder Number: 5955460 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1686-2014·2014-06-11

    Bard Composix LIP Mesh Recall Due to Potential Sterility Compromise

    Davol, Inc. is recalling Bard Composix LIP Mesh with Echo PS because the sterile inflation assembly packaging may be open or have a weak seal.

    Product
    Bard¿ Composix" LIP Mesh with Echo PS" 8"x10" Reorder Number: 0144810 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-1691-2014·2014-06-11

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

    Davol, Inc. is recalling Bard Ventralight ST Mesh with Echo PS 6" Circle due to potential defects in the sterile inflation assembly pouch seal.

    Product
    Bard¿ Ventralight" ST Mesh with Echo PS" 6" CircleReorder Number: 5955600 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-1695-2014·2014-06-11

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

    Davol, Inc. is recalling Bard Ventralight ST Mesh with Echo PS 8" Circle because the sterile pouch holding the inflation assembly may be open or have a weak seal.

    Product
    Bard¿ Ventralight" ST Mesh with Echo PS" 8" Circle Number: 5955800 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-1684-2014·2014-06-11

    Davol Composix LP Hernia Mesh Recall Due to Packaging Seal Defects

    Davol, Inc. is recalling Composix LP hernia mesh because the sterile packaging may have weak seals, potentially compromising sterility.

    Product
    Composix" LP with Echo PS" 6x8 Reorder Number: 0144680 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-1682-2014·2014-06-11

    Davol Composix LP Hernia Mesh Recall Due to Packaging Seal Issues

    Davol, Inc. is recalling Composix LP hernia mesh because the sterile packaging may have weak seals, potentially compromising sterility.

    Product
    Composix" LP with Echo PS" 10x13 HUXH0294 HUXL0314 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-1689-2014·2014-06-11

    Bard Ventralight ST Mesh Recall for Potential Sterile Pouch Seal Issues

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

    Product
    Bard¿ Ventralight" ST Mesh with Echo PS" 4.5" Circle Reorder Number: 5955450 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-1685-2014·2014-06-11

    Bard Composix LIP Mesh Recall Due to Potential Packaging Seal Defects

    Davol, Inc. is recalling specific lots of Bard Composix LIP Mesh because the sterile packaging may be open or have a weak seal, potentially compromising sterility.

    Product
    Bard¿ Composix" LIP Mesh with Echo PS" 7"x9" Reorder Number: 0144790 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-1696-2014·2014-06-11

    Bard Ventralight ST Mesh Recalled for Potential Sterile Pouch Seal Defects

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

    Product
    Bard¿ Ventralight" ST Mesh with Echo PS" 8"x10" Reorder Number: 5955810 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-1693-2014·2014-06-11

    Bard Ventralight ST Mesh Recall for Potential Sterility Compromise

    Davol, Inc. is recalling specific lots of Bard Ventralight ST Mesh because the sterile packaging may be open or have a weak seal, potentially compromising sterility.

    Product
    Bard¿ Ventralight" ST Mesh with Echo PS" 6"x8" Reorder Number: 5955680 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-1687-2014·2014-06-11

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

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

    Product
    Bard¿Ventralight" ST Mesh with Echo PS" 10"x13" Reorder Number: 5955113 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-1688-2014·2014-06-11

    Bard Ventralight ST Mesh Recall Due to Potential Pouch Seal Failure

    Davol, Inc. is recalling Bard Ventralight ST Mesh with Echo PS due to potential pouch seal failures that could compromise sterility.

    Product
    Bard¿ Ventralight" ST Mesh with Echo PS" 12"x14" Reorder Number: 5955124 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-1683-2014·2014-06-11

    Davol Composix LP Hernia Mesh Recall Due to Packaging Seal Defects

    Davol, Inc. is recalling Composix LP with Echo PS hernia mesh because the sterile packaging may be open or have a weak seal, potentially compromising sterility.

    Product
    Composix" LP with Echo PS" 6x10 Reorder Number: 0144610 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1626-2014·2014-05-28

    Hospira Recalls Large Bore Y-Irrigation Sets Due to Packaging Seal Defect

    Hospira is recalling specific lots of Large Bore Y-Irrigation Sets because the Tyvek cover may not be completely sealed, potentially compromising the sterile package.

    Product
    LATEX-FREE; LARGE BORE Y-IRRIGATION SET; Nonvented Set; 100 inch (254 cm); For Flexible Irrigation Container Systems; List No. 6599-01; single use; Hospira Product Usage: For Use With Flexible Irrigation Container Systems
    Category
    Medical Device
    Distribution
    Distributed nationwide