The Recall Desk

Hazard

Sterility Compromise recalls

2,235 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
2,235
Critical
4
Severe
260
Most recent
2026-09-30

Of the 2,235 sterility compromise recalls we have scored against our rubric, 4 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 260 (12%) 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.

1051–1075 of 2235

  • HighFDA (Devices)·Z-2143-2017·2017-05-31

    Cardinal Health Recalls Jackson-Pratt Silicone Flat Drains Due to Sterility Concerns

    Cardinal Health 200, LLC is recalling Jackson-Pratt Silicone Flat Drains because the product seal may be compromised, potentially compromising sterility and increasing the risk of infection.

    Product
    Jackson-Pratt Silicone Flat Drain, 7mm, Full Ducts. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2146-2017·2017-05-31

    Cardinal Health Recalls Jackson-Pratt Silicone Round Drains Due to Seal Compromise

    Cardinal Health 200, LLC is recalling Jackson-Pratt Silicone Round Drains because the product seal may be compromised, potentially compromising sterility and increasing infection risk.

    Product
    Jackson-Pratt Silicone Round Drain, 10FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2147-2017·2017-05-31

    Cardinal Health Recalls Jackson-Pratt Silicone Round Drains Due to Sterility Concerns

    Cardinal Health 200, LLC is recalling specific lots of Jackson-Pratt Silicone Round Drains because the product seal may be compromised, potentially increasing the risk of infection.

    Product
    Jackson-Pratt Silicone Round Drain, 15FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2139-2017·2017-05-31

    Cardinal Health Recalls Jackson-Pratt Hemaduct Silicone Round Drains

    Cardinal Health 200, LLC is recalling Jackson-Pratt Hemaduct Silicone Round Drains because the product seal may be compromised, potentially compromising sterility and increasing infection risk.

    Product
    Jackson-Pratt Hemaduct Silicone Round Drain, 10FR W/Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2131-2017·2017-05-31

    Cardinal Health Recalls Jackson-Pratt Hemaduct Cardiothoracic Silicone Round Drains

    Cardinal Health is recalling specific lots of Jackson-Pratt Hemaduct Cardiothoracic Silicone Round Drains because the product seal may be compromised, potentially compromising sterility and increasing infection risk.

    Product
    Jackson-Pratt Hemaduct Cardiothoracic Silicone Round Drain,19FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2145-2017·2017-05-31

    Cardinal Health Recalls Jackson-Pratt Silicone Round Drains Due to Seal Compromise

    Cardinal Health 200, LLC is recalling Jackson-Pratt Silicone Round Drains because the product seal may be compromised, potentially compromising sterility and increasing infection risk.

    Product
    Jackson-Pratt Silicone Round Drain, 7FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2133-2017·2017-05-31

    Cardinal Health Recalls Jackson-Pratt Hemaduct Silicone Flat Drains

    Cardinal Health 200, LLC is recalling Jackson-Pratt Hemaduct Silicone Flat Drains because the product seal may be compromised, potentially compromising sterility and increasing infection risk.

    Product
    Jackson-Pratt Hemaduct Silicone Flat Drain, 10mm, Full Ducts W/15FR Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2141-2017·2017-05-31

    Cardinal Health Recalls Jackson-Pratt Silicone Flat Drains Due to Sterility Concerns

    Cardinal Health is recalling specific lots of Jackson-Pratt Silicone Flat Drains because the product seal may be compromised, potentially increasing the risk of infection.

    Product
    Jackson-Pratt Silicone Flat Drain, 7mm, 3/4 Ducts. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2148-2017·2017-05-31

    Cardinal Health Recalls Jackson-Pratt Silicone Round Drains Due to Sterility Concerns

    Cardinal Health 200, LLC is recalling specific lots of Jackson-Pratt Silicone Round Drains because the product seal may be compromised, potentially increasing the risk of infection.

    Product
    Jackson-Pratt Silicone Round Drain, 19FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2050-2017·2017-05-17

    Mederi Stretta Catheter Recalled Due to Sterility Compromise

    Mederi Therapeutics is recalling 1,458 Stretta Catheter kits because a breach in the sterile barrier package compromised sterility.

    Product
    Mederi Stretta Catheter and Accessory Kit, Sterile For Use with the MEDERI MDRF1 GENERATOR ONLY. Used in the treatment of gastroesophageal reflux disease (GERD). REF 175-5580
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1837-2017·2017-04-26

    Alcon Recalls Patient Care Kits Due to Sterile Packaging Concerns

    Alcon is voluntarily removing 561,702 Patient Care Kits from the US market because the supplier reported potential sterile packaging compromise.

    Product
    Alcon Patient Care Kits Product Usage: A Patient Care Kit is an assemblage of single-use medical devices and accessories designed by medical professionals for specific procedures. The Patient Care kits are configured with customer-specific components
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1817-2017·2017-04-19

    Micromedics FibriJet Endoscopic Catheter Introducer Recalled for Packaging Seal Defects

    Micromedics, Inc. is recalling 273 units of FibriJet Endoscopic Catheter Introducers because small channels in the sterile packaging seal may compromise package integrity and sterility assurance.

    Product
    Nordson Micromedics FibriJet Endoscopic Catheter Introducer, Catalog Number SA-3445. Sterilized using Ethylene Oxide
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-1798-2017·2017-04-19

    Windstone Medical Setup Packs Recalled for Potential Sterility Compromise

    Windstone Medical Packaging is recalling 500 Setup Packs containing Medtronic Curity Eye Pads due to potential sterile packaging compromise.

    Product
    Setup Pack, part number AMS3112(A Product packaged in a convenient manner for use in a general clinical procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1793-2017·2017-04-19

    Windstone Medical Minor Operation Kit Recall Due to Sterile Packaging Concerns

    Windstone Medical Packaging is recalling 700 Minor Operation Kits because the sterile packaging of the included Medtronic Curity Eye Pad may be compromised.

    Product
    Minor Operation Kit, part number AMS1530 Product packaged in a convenient manner for use in a general clinical procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1795-2017·2017-04-19

    Windstone Medical Recalls Ortho Basic Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 12 Ortho Basic Packs because the sterile packaging of the included eye pads may be compromised.

    Product
    Ortho Basic Pack, part number AMS6459 Product packaged in a convenient manner for use in a general clinical procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1786-2017·2017-04-19

    Windstone Medical Recalls Custom Kits with Compromised Sterile Eye Pad Packaging

    Windstone Medical Packaging is recalling 164 custom kits containing Medtronic Curity Eye Pads due to potential sterile packaging compromise.

    Product
    Custom Tray, part numbers PSS1111 and PSS1111(A. Product packaged in a convenient manner for use in a general clinical procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1796-2017·2017-04-19

    Windstone Medical Packaging Recalls Plastic Packs with Compromised Sterile Eye Pads

    Windstone Medical Packaging is recalling 376 plastic kits containing Medtronic Curity Eye Pads because the sterile packaging may be compromised.

    Product
    Plastic Pack, part numbers AMS1028, AMS1028(A, and WAL1189. Product packaged in a convenient manner for use in a general clinical procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1783-2017·2017-04-19

    Windstone Medical Packaging Recalls Cataract Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 4,065 cataract kits because the sterile packaging of the included eye pads may be compromised.

    Product
    Cataract Kit, part numbers CAT1467AM and CAT1538(B. Product packaged in a convenient manner for use in a general clinical procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1791-2017·2017-04-19

    Windstone Medical Eye Pack Recall Due to Sterile Packaging Compromise

    Windstone Medical Packaging is recalling 1,330 Eye Packs because the sterile packaging of the included eye pads may be compromised.

    Product
    Eye Pack, part numbers WAL1085(B and WAL1085(C\ Product packaged in a convenient manner for use in a general clinical procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1788-2017·2017-04-19

    Windstone Medical Recalls Dr. Wischmeier Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 1,170 Dr. Wischmeier Packs because the sterile packaging of the included eye pads may be compromised.

    Product
    Dr. Wischmeier Pack, part numbers: AMS3509 and AMS3509(A Product packaged in a convenient manner for use in a general clinical procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1787-2017·2017-04-19

    Windstone Medical Recalls Dicken Eye Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 172 Dicken Eye Packs because the sterile packaging of the eye pads may be compromised.

    Product
    Dicken Eye Pack, part number CPA-3202-2. Product packaged in a convenient manner for use in a general clinical procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1794-2017·2017-04-19

    Windstone Medical Ophthalmic Packs Recalled for Sterile Packaging Compromise

    Windstone Medical Packaging is recalling 169 ophthalmic packs containing Medtronic Curity Eye Pads because the sterile packaging may be compromised.

    Product
    Ophthalmic Pack, Part number WAL1107(A and WAL1190 Product packaged in a convenient manner for use in a general clinical procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1799-2017·2017-04-19

    Windstone Medical Vitrectomy Kits Recalled for Sterile Packaging Compromise

    Windstone Medical Packaging is recalling Vitrectomy Kits because the sterile packaging of the included Medtronic Curity Eye Pad may be compromised.

    Product
    Vitrectomy Kit, part number CMP1016(A. Product packaged in a convenient manner for use in a general clinical procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1784-2017·2017-04-19

    Windstone Medical Recalls Cataract Kits Due to Sterile Packaging Concerns

    Windstone Medical Packaging is recalling 990 cataract kits because the sterile packaging of the included eye pads may be compromised.

    Product
    Cataract Kit - Dr. Slingsby, part number CMP1017(B. Product packaged in a convenient manner for use in a general clinical procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1744-2017·2017-04-12

    Recall of Curity Sodium Chloride Dressings Due to Sterility Compromise

    Covidien LLC is recalling Curity Sodium Chloride Dressings because the sterile barrier is breached, compromising sterility. The recall affects lots with expiration dates from February 2017 through November 2019.

    Product
    Covidien Curity Sodium Chloride Dressing , 6 x 6-3/4 (15.2 cm x 17.1 cm), Sterile Item Code: 3339 Curity Sodium Chloride Dressing is indicated for use on exudating and/or infected wounds
    Category
    Medical Device
    Distribution
    Distributed nationwide