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.

1076–1100 of 2235

  • SevereFDA (Devices)·Z-1745-2017·2017-04-12

    Recall of Curity Saline Dressings Due to Compromised Sterility

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

    Product
    Covidien Curity Saline Dressing 8' x 4 (20.3cm x10.2 cm), Sterile Item Code: 3606 Curity sodium chloride dressing is saturated in a 20% hypertonic saline solution. The dressing is designed to help promote biological cleansing within the wound and aid in the autolytic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1741-2017·2017-04-12

    Recall of Sterile Eye Pads Due to Compromised Sterility Barrier

    Covidien is recalling Curity Eye Pads because the sterile barrier was breached, potentially compromising sterility. The recall affects units distributed worldwide.

    Product
    Covidien Curity Eye Pad Item Code: 91650 The sterile eye pad is a device that consists of a pad made of various materials, such as gauze and cotton, intended for use as a bandage over the eye for protection or absorption of secretions. It is supplied sterile to allow for use…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1743-2017·2017-04-12

    Sterile Saline Dressing Recalled Due to Compromised Sterility Barrier

    FDA is recalling Kerlix Super Sponge Saline Dressings because the sterile barrier is breached, potentially compromising sterility.

    Product
    Covidien Kerlix Super Sponge Saline Dressing, Sterile Item Code: 3338 Curity sodium chloride dressing is saturated in a 20% hypertonic saline solution. The dressing is designed to help promote biological cleansing within the wound and aid in the autolytic debridement process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1742-2017·2017-04-12

    Recall of Sterile Wound Dressings Due to Compromised Sterility Barrier

    Covidien is recalling Curity Wet Dressings because the sterile barrier was breached, potentially compromising sterility. The recall affects units distributed worldwide.

    Product
    Covidien Curity Wet Dressing 8 x 4 (20.3 cm x 10.2 cm), Sterile Item Code: 3337 Curity sodium chloride dressing is saturated in a 20% hypertonic saline solution. The dressing is designed to help promote biological cleansing within the wound and aid in the autolytic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1740-2017·2017-04-12

    Recall of Sterile Eye Pads Due to Compromised Sterility Barrier

    Covidien LLC is recalling Curity Eye Pads because the sterile barrier was breached, potentially compromising sterility.

    Product
    Covidien Curity Eye Pad Oval, 1-5/8 x 2-5/8 (4.2 cm x 6.7 cm), Sterile Item Code: 2841 The sterile eye pad is a device that consists of a pad made of various materials, such as gauze and cotton, intended for use as a bandage over the eye for protection or absorption of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1669-2017·2017-04-05

    Recall of Regard Sterile Custom Procedure Trays Due to Glove Splitting

    Resource Optimization & Innovation LLC is recalling 32 kits of Regard sterile custom procedure trays because a light glove component can split during application, breaking the sterile field.

    Product
    Regard, Item Number: 800508004, Sterile, LD0586D - C Section - Jasper
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1667-2017·2017-04-05

    Recall of Regard Sterile Procedure Trays Due to Splitting Glove Component

    Resource Optimization & Innovation LLC is recalling 126 kits of Regard sterile procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800508002, Sterile, LD0586B - C Section - Jasper
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1539-2017·2017-03-29

    Integra Recalls Panta Nails Due to Potential Sterility Seal Issues

    Integra LifeSciences is voluntarily recalling Panta and Panta XI Nails because package seals may not maintain intended sterility.

    Product
    Panta Nail, Rx only, Sterile,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1478-2017·2017-03-22

    Inion GRT Tack Recall Due to Defective Aluminum Pouch Seal

    Inion Ltd. is recalling 36 sterile Inion GRT Tack kits distributed in Florida and North Carolina because the aluminum pouch seal was found to be slightly open.

    Product
    Inion GRT Tack, drill bit and tack appl., 4x, Sterile. Is indicated for the surgical treatment of periodontal defects to aid in the regeneration and integration of tissue components in guided tissue regeneration procedures, for pre-implant and peri-implant surgery and for…
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1409-2017·2017-03-15

    FDA Recalls Premier Guard Drape Due to Sterility Compromise

    The FDA is recalling Premier Guard Drape, Sterile, because the sterile barrier was breached, compromising sterility. The product is used with RF Surgical Gauze detection systems.

    Product
    Premier Guard Drape, Sterile. For Use with Verisphere (01-0035) and ArQ.Sphere (01-0044) Item Number: 01-0037 Used in conjunction RF Surgical Gauze detection systems to protect scanning device from contamination during various surgical procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1408-2017·2017-03-15

    FDA Recalls Premier Guard Sterile Drapes Due to Sterility Compromise

    The FDA is recalling Premier Guard Sterile Drapes because the sterile barrier was breached, compromising sterility. The recall covers 1,111,600 units distributed nationwide.

    Product
    Premier Guard Sterile Drape For Use with Blair-Port Wand (02-0029) and Blair-Port Wand X (01-0046) Item Number: 01-0020 Used in conjunction RF Surgical Gauze detection systems to protect scanning device from contamination during various surgical procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1368-2017·2017-03-08

    Windstone Medical Packaging Recalls Shoulder Arthroscopy Packs Due to Sterility Risk

    Windstone Medical Packaging is recalling 606 Shoulder Arthroscopy Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Shoulder Arthroscopy Pack, part number AMS2496(A Shoulder Arthroscopy Pack, part number AMS2496(B Shoulder Arthroscopy Pack, part number AMS2496(C Shoulder Arthroscopy Pack, part number AMS2609 Shoulder Arthroscopy Pack, part number AMS3857 Shoulder Arthroscopy Pack, part…
    Category
    Medical Device
    Distribution
    26 states
  • SevereFDA (Devices)·Z-1329-2017·2017-03-08

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES in custom Aligned Medical Solutions kits are recalled because splits or holes may compromise sterility.

    Product
    Lap/Pelviscopy Pack, part number PSS3256(B
    Category
    Medical Device
    Distribution
    26 states
  • SevereFDA (Devices)·Z-1379-2017·2017-03-08

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES in custom Aligned Medical Solutions kits are being recalled because splits or holes may compromise sterility.

    Product
    Upper Torso Tray, part number PSS1554(B
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-1363-2017·2017-03-08

    Windstone Medical Packaging Recalls Podiatry Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 2,018 Podiatry Packs because the disposable gloves included may have splits or holes that compromise sterility.

    Product
    Podiatry Pack, part number AMS2778 Podiatry Pack, part number AMS2778(A Podiatry Pack, part number AMS3785(B Podiatry Pack, part number AMS3785(C Podiatry Pack, part number AMS4011(A Podiatry Pack, part number PSS3422(A
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-1332-2017·2017-03-08

    Windstone Medical Packaging Recalls Laparotomy Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 331 laparotomy packs because the disposable gloves inside may contain splits or holes that compromise sterility.

    Product
    Laparotomy Pack, part number 006268-9 Laparotomy Pack, part number AMS4418(A Laparotomy Pack, part number PSS2190(A
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-1322-2017·2017-03-08

    Windstone Medical Knee Scope Packs Recalled for Sterility Compromise

    Windstone Medical Packaging is recalling 156 Knee Scope Packs because the disposable gloves included may have splits or holes that compromise sterility.

    Product
    Knee Scope Pack, part number AMS2498(A Knee Scope Pack, part number AMS2498(B Knee Scope Pack, part number AMS2498(C
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-1355-2017·2017-03-08

    Windstone Medical Packaging Recalls Ortho Packs with Defective Gloves

    Windstone Medical Packaging is recalling 84 Ortho Pack kits because the included Medtronic gloves may have splits or holes that compromise sterility.

    Product
    Ortho Pack, part number PSS3466(A
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-1294-2017·2017-03-08

    Windstone Medical ENT Packs Recalled for Potential Sterility Compromise

    Windstone Medical Packaging is recalling 390 ENT Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    ENT Pack, part number AMS3237(A ENT Pack, part number AMS4214
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-1350-2017·2017-03-08

    Windstone Medical Packaging Recalls Open Procedure Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 1,125 Open Procedure Packs because the disposable gloves included may have splits or holes that compromise sterility.

    Product
    Open Procedure Pack, part number AMS4596 Open Procedure Pack, part number AMS4596(A Open Procedure Pack, part number AMS4596(B
    Category
    Medical Device
    Distribution
    26 states