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.

801–825 of 2228

  • ModerateFDA (Devices)·Z-0162-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues

    Zimmer Biomet is recalling 20 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and abroad.

    Product
    Affixus Hip Fracture Nail Right 130 11 mm x 400 mm, Item Number 814511400 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0158-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Defects

    Zimmer Biomet is recalling 85 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and abroad.

    Product
    Affixus Hip Fracture Nail 130 11 mm x 180 mm, Item Number 814511180 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3212-2018·2018-10-03

    Medtronic Clip Gun Magazines Recalled for Packaging Sterility Defect

    Medtronic Neurosurgery is recalling Clip Gun Magazines because the packaging sterile barrier may be compromised without visible signs.

    Product
    Medtronic Clip Gun Magazines are packaged in individually sealed pouches and distributed in boxes containing 5 individually pouched Clip Gun Magazine. REF CM8902, Medtronic Clip Gun Magazine, Rx only, CE 0344, STERILE EO, Rx only, Single Use
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-3278-2018·2018-10-03

    CooperSurgical Retractor System Elastic Stays Recalled for Potential Seal Compromise

    CooperSurgical is recalling 18,000 units of Retractor System Elastic Stays because the sterile pouch seal may be compromised, increasing the risk of infection.

    Product
    Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG) Product Usage: The Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG) are a sterile single-use medical device providing retraction to achieve and maintain optimal visualization throughout a variety o
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2908-2018·2018-09-05

    Stryker QUIKFLAP Burr Hole Cover Recall Due to Packaging Compromise

    Stryker is recalling QUIKFLAP burr hole covers because the sterile packaging may become compromised after three years.

    Product
    QUIKFLAP, 1X20MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01536S, for use on the cranium
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2899-2018·2018-09-05

    Stryker QuickFlap Sterile Procedure Packs Recalled for Packaging Compromise

    Stryker is recalling QuickFlap Sterile Procedure Packs because the sterile barrier may become compromised after three years.

    Product
    QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01521S The Stryker QuickFlap Sterile Procedure Pack is intended for reconstruction, stabilization and/or rigid fixation of non-load bearing bony areas subsequent to craniotomy, craniectomy an
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2914-2018·2018-09-05

    Stryker AXS PP Burr Hole Cover Recall Due to Packaging Compromise

    Stryker is recalling AXS PP burr hole covers because the sterile packaging may become compromised after three years, potentially affecting sterility.

    Product
    AXS PP, 1X20MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01546S, for use on the cranium
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2913-2018·2018-09-05

    Stryker AXS PP Burr Hole Cover Recall for Packaging Compromise

    Stryker is recalling AXS PP burr hole covers because the sterile packaging may become compromised after three years.

    Product
    AXS PP, 1X14MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01544S, for use on the cranium
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2904-2018·2018-09-05

    Stryker QUIKFLAP Cranium Plates Recalled for Sterile Barrier Compromise

    Stryker is recalling QUIKFLAP cranium plates because the sterile packaging may become compromised after three years, potentially affecting sterility.

    Product
    QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01530S, for use on the cranium
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2915-2018·2018-09-05

    Stryker AXS PP Burr Hole Cover Recall Due to Packaging Compromise

    Stryker is recalling AXS PP Burr Hole Covers because the sterile packaging may become compromised after three years, potentially affecting sterility.

    Product
    AXS PP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01548S, for use on the cranium
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2900-2018·2018-09-05

    Stryker QUIKFLAP Cranium Plates Recalled for Packaging Compromise

    Stryker is recalling QUIKFLAP cranium plates because the sterile packaging may become compromised after three years.

    Product
    QUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01522S, for use on the cranium.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2907-2018·2018-09-05

    Stryker QUIKFLAP Burr Hole Cover Recall Due to Packaging Compromise

    Stryker is recalling QUIKFLAP burr hole covers because the sterile packaging may become compromised after three years.

    Product
    QUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01534S, for use on the cranium
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2911-2018·2018-09-05

    Stryker AXS PP Cranium Plates Recalled for Packaging Compromise

    Stryker is recalling 22,831 AXS PP cranium plates because the sterile packaging may become compromised after three years.

    Product
    AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01541S, for use on the cranium
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2898-2018·2018-09-05

    Stryker QuickFlap Sterile Procedure Pack Recalled for Packaging Compromise

    Stryker is recalling QuickFlap Sterile Procedure Packs because the sterile barrier may become compromised after three years.

    Product
    QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01520S The Stryker QuickFlap Sterile Procedure Pack is intended for reconstruction, stabilization and/or rigid fixation of non-load bearing bony areas subsequent to craniotomy, craniectomy a
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2901-2018·2018-09-05

    Stryker QUIKFLAP Burr Hole Cover Recall Due to Packaging Compromise

    Stryker is recalling QUIKFLAP burr hole covers because the sterile packaging may become compromised after three years.

    Product
    QUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01524S, for use on the cranium
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2903-2018·2018-09-05

    Stryker Quikflap Burr Hole Cover Recall Due to Packaging Compromise

    Stryker is recalling Quikflap burr hole covers because the sterile packaging may become compromised after three years.

    Product
    QUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01528S, for use on the cranium
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2884-2018·2018-08-29

    Stryker T2 Orthopedic Nails Recalled for Incomplete Sterility Seal

    Stryker GmbH is recalling 38 T2 orthopedic nails due to incomplete Tyvek lid seals that may compromise sterility.

    Product
    Stryker T2 ANKLE ARTHRODESIS NAIL RIGHT 10MMX200MM Item Number: 1819-1020S T2 ANKLE ARTHRODESIS NAIL RIGHT 12MMX200MM 1819-1220S T2 LONG PROXIMAL HUMERAL NAIL LEFT 240mm1832-2824S T2 LONG PROXIMAL HUMERAL NAIL LEFT 280mm 1832-2828S T2 LONG PROXIMAL HUMERAL NAIL RIGHT 260mm 18
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2819-2018·2018-08-22

    Arrow Hands-Off Central Venous Catheter Recalled for Packaging Seal Issues

    Arrow International is recalling 5,507 units of Hands-Off Multi-Lumen Central Venous Catheters because packaging may not be sealed, potentially compromising sterility.

    Product
    HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous Sheath Introducer System, Material HO-14703 The central venous catheter permits venous access to the central circulation through an indwelling Arrow percutaneous she
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2818-2018·2018-08-22

    Arrow Hands-Off Central Venous Catheter Recalled for Packaging Seal Defects

    Arrow International Inc. is recalling 7,024 units of Hands-Off Multi-Lumen Central Venous Catheters because packaging may not be sealed, potentially compromising sterility.

    Product
    HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous Sheath Introducer System, Material HO-14702 The central venous catheter permits venous access to the central circulation through an indwelling Arrow percutaneous shea
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0965-2018·2018-07-25

    Avella Recalls Phenylephrine Bags Due to Potential Leakage and Sterility Concerns

    Avella of Deer Valley is recalling 40 bags of Phenylephrine 10 mg due to potential leakage that compromises sterility. The product was distributed nationwide.

    Product
    PHENYLephrine 10 mg (PHENYLephrine HCL (USP) 10mg, 0.9% Sodium Chloride (USP) 250 mL. Volume: 251 mL Single dose bag. For: Redlands Community Hospital Pharmacy. BY: Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054 NDC 15082-856-25
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0954-2018·2018-07-25

    Avella Recalls Morphine Syringes Due to Potential Sterility Compromise

    Avella of Deer Valley, Inc. is recalling 740 single-dose Morphine 150 mg syringes due to a lack of assurance of sterility caused by potential bag leakage.

    Product
    MORphine 150 mg (Morphine Sulfate, USP 150mg in 0.9% Sodium Chloride, USP QS 30mL). Volume 30 mL. Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-243-63
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0959-2018·2018-07-25

    Avella Recalls Norepinephrine Syringes Due to Potential Sterility Compromise

    Avella of Deer Valley, Inc. is recalling 850 single-dose norepinephrine syringes nationwide due to potential bag leakage that may compromise sterility.

    Product
    NORepiNEPHrine Bitartrate, USP 160 mcg in 5% Dextrose, USP QS 10mL. Volume 10mL. Single dose syringe. Avella of Houston, 9265 Kirby Dr. Houston, TX 77054. NDC 42852-807-61
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0941-2018·2018-07-25

    Avella Recalls Vancomycin Bags Due to Potential Leakage

    Avella of Deer Valley is recalling 1,352 bags of Vancomycin 1.25gm in D5W 250 mL due to potential leakage that compromises sterility.

    Product
    Vancomycin 1.25gm in D5W 250 mL. ( Vancomycin HCL (USP) 1.25 gm, 5% Dextrose Inj. (USP) 250 mL) Volume: 262 mL. Single dose bag. Avella Specialty Pharmacy, 24416N 19th Avenue, Phoenix, AZ 85085. NDC 42852-617-25
    Category
    Drug
    Distribution
    Distributed nationwide