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.

676–700 of 2228

  • HighFDA (Devices)·Z-2044-2019·2019-07-31

    Cardinal Health Recalls Monoject Hypodermic Needles Due to Sterility Defect

    Cardinal Health is recalling Monoject 201 Vet Pak Hypodermic Needles because a manufacturing defect in the cartridge component could compromise the product's sterility barrier.

    Product
    Monoject 201 Vet Pak Hypodermic Needle, 20 ga x 1-1/2" Item code: 8881201498
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2052-2019·2019-07-31

    Cardinal Health Recalls Monoject Blunt Cannula Due to Sterility Barrier Defect

    Cardinal Health 200, LLC is recalling Monoject Blunt Cannula 22 G x 1-1/2" (Item code: 8881202389) because a manufacturing defect in the cartridge component could compromise the product's sterility barrier.

    Product
    Monoject Blunt Cannula, 22 G x 1-1/2" (0.711 mm x 3.8 cm) Item code: 8881202389
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2039-2019·2019-07-31

    Cardinal Health Recalls Monoject Hypodermic Needles Due to Sterility Barrier Defect

    Cardinal Health is recalling Monoject Standard Hypodermic Needles because a manufacturing defect in the cartridge component could compromise the product's sterility barrier.

    Product
    Monoject Standard Hypodermic Needle, 16 G x 1-1/2" Item code:8881200045
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2043-2019·2019-07-31

    Cardinal Health Recalls Monoject 201 Vet Pak Hypodermic Needles

    Cardinal Health is recalling Monoject 201 Vet Pak Hypodermic Needles due to a manufacturing defect that could compromise the product's sterility barrier.

    Product
    Monoject 201 Vet Pak Hypodermic Needle, 22 ga x 1-1/2" Item code: 8881201456
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2005-2019·2019-07-31

    Terumo Medical Recalls 23G Needles Due to Potential Sterility Compromise

    Terumo Medical Corporation is recalling 30,000 units of 23G x 1-inch needles (Lot 180811C) because a potential loss of package integrity may compromise the product's sterility.

    Product
    Terumo Needle, 23G x 1", Product Code NN2325R
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-2040-2019·2019-07-31

    Cardinal Health Recalls Monoject Hypodermic Needles Due to Sterility Barrier Defect

    Cardinal Health is recalling Monoject Standard Hypodermic Needles because a manufacturing defect in the cartridge component could compromise the product's sterility barrier.

    Product
    Monoject Standard Hypodermic Needle, 18 G x 1-1/2" Item code: 8881200078
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2047-2019·2019-07-31

    Cardinal Health Recalls Monoject 201 Vet Pak Hypodermic Needles

    Cardinal Health is recalling Monoject 201 Vet Pak Hypodermic Needles due to a manufacturing defect that could compromise the sterility barrier.

    Product
    Monoject" 201 Vet Pak Hypodermic Needle, 16 ga x 1-1/2 Item code: 8881201654
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2050-2019·2019-07-31

    Cardinal Health Recalls Monoject Blunt Cannula Due to Sterility Barrier Defect

    Cardinal Health 200, LLC is recalling Monoject Blunt Cannulas due to a manufacturing defect that could compromise the product's sterility barrier.

    Product
    Monoject Blunt Cannula, 19 G x 1-1/2" (1.067 mm x 3.8 cm) Item code: 8881202355
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2038-2019·2019-07-31

    Cardinal Health Recalls Monoject Hypodermic Needles Due to Sterility Barrier Defect

    Cardinal Health 200, LLC is recalling specific lots of Monoject Standard Hypodermic Needles because a manufacturing defect in the cartridge component could compromise the product's sterility barrier.

    Product
    Monoject Standard Hypodermic Needle, 16 G x 1-1/2" Item code: 8881200037
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2061-2019·2019-07-31

    Medela Breast Milk Transfer Lid Recall for Packaging Sterility Concerns

    Medela Inc is recalling 665,600 breast milk transfer lids because packaging breaches may compromise sterility, even if the packaging appears intact.

    Product
    Breast Milk Transfer Lid for use with Oral Syringe Connectors Model: 90003S-100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2006-2019·2019-07-31

    Terumo 30G Needle Recall Due to Potential Sterility Compromise

    Terumo Medical Corporation is recalling 81,000 30G needles due to a potential loss of package integrity that may compromise sterility.

    Product
    Terumo Needle, 30G x 1/2", Product Code NN3013R
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-2001-2019·2019-07-31

    Terumo Sur-vet Needle Recall Due to Potential Loss of Package Integrity

    Terumo Medical Corporation is recalling 440,000 Sur-vet Needles due to a potential loss of package integrity that may compromise sterility.

    Product
    Terumo Sur-vet Needle, 25G x 5/8", Product Code 100220
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-2000-2019·2019-07-31

    Terumo Sur-vet Needle Recall Due to Potential Sterility Compromise

    Terumo Medical Corporation is recalling 638,000 Sur-vet Needles due to a potential loss of package integrity that may compromise sterility.

    Product
    Terumo Sur-vet Needle, 22G x 3/4", Product Code 100215
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-1981-2019·2019-07-24

    DeRoyal Custom Surgical Packs Recalled for Sterility Barrier Defect

    DeRoyal is recalling 108 custom surgical packs in Oklahoma because they contain defective Cardinal Health Blunt Cannulas that could compromise sterility.

    Product
    DeRoyal THE RESOURCE GROUP, CRANI PACK, REF 89-9211.07 custom surgical pack
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1947-2019·2019-07-10

    Zimmer Biomet Recalls DVR Crosslock ePAK Depth Gauges for Packaging Defects

    Zimmer Biomet is recalling DVR Crosslock ePAK Depth Gauges due to a potential for weak seals in the sterile packaging.

    Product
    DVR Crosslock ePAK Depth Gauge, Model Number 212000003 Product Usage: These DVR Express Disposable Instruments are used to facilitate implantation of orthopedic medical devices in trauma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1946-2019·2019-07-10

    Zimmer Biomet Recalls DVR Crosslock ePAK Screw Drivers Due to Packaging Seal Risk

    Zimmer Biomet is recalling 3,022 DVR Crosslock ePAK Screw Drivers because sterile packaging seals may be weak, potentially compromising sterility.

    Product
    DVR Crosslock ePAK Screw Driver, Model Number 212000002 Product Usage: These DVR Express Disposable Instruments are used to facilitate implantation of orthopedic medical devices in trauma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1948-2019·2019-07-10

    Zimmer Biomet Recalls K-Wire Trochar Tips Due to Packaging Seal Issues

    Zimmer Biomet is recalling K-Wire Trochar Tips because the sterile packaging may have weak seals, potentially compromising the device's sterility.

    Product
    K-Wire Trochar Tip, Model Number 212000008 Product Usage: These DVR Express Disposable Instruments are used to facilitate implantation of orthopedic medical devices in trauma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1887-2019·2019-07-03

    AtriCure EPi-Sense Guided Coagulation System Recalled for Compromised Sterile Seal

    AtriCure is recalling 497 units of the EPi-Sense Guided Coagulation System because the sterile package seal may be compromised, posing a risk of infection.

    Product
    EPi-Sense Guided Coagulation System with Visitrax, MOdel No. CDK-1413 - Product Usage: The EPi-Sense Guided Coagulation System with VisiTrax, consists of a sterile, single-use, disposable coagulation electrode device (1cm, 2cm, and 3cm sizes provided) intended to be used to coagu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1848-2019·2019-06-26

    Stryker Recalls Endotrac Hook/Triangle Blade Kits Due to Seal Integrity

    Stryker GmbH is recalling 447 Endotrac ECTR Hook/Triangle Blade Kits because the sterile bag seal may be compromised, potentially affecting sterility.

    Product
    Endotrac ECTR Hook/Triangle Blade Kit, Catalogue Number 2056-1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1849-2019·2019-06-26

    Stryker Endotrac Hook/Triangle Blade Kit Recall Due to Seal Integrity

    Stryker GmbH is recalling 1,600 Endotrac EPF/EGR Hook/Triangle Blade Kits because the sterile bag seal integrity may be compromised.

    Product
    Endotrac EPF/EGR Hook/Triangle Blade Kit, Catalogue Number 3056-1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1780-2019·2019-06-19

    Cook Inc. Recalls Neff Percutaneous Access Sets Due to Sterility Concerns

    Cook Inc. is recalling 97 Neff Percutaneous Access Sets because they may have been manufactured without a bottom seal, compromising sterility. No US distribution occurred.

    Product
    Neff Percutaneous Access Set, Catalog Number NPAS-100-RH-NT
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1719-2019·2019-06-12

    Centurion Medical Recalls Sterile Nail Clippers Due to Compromised Seals

    Centurion Medical Products Corporation is recalling sterile nail clippers because the sterile barrier pouch seals are compromised, potentially affecting sterility.

    Product
    Sterile Nail Clipper Concave Edge (67710)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1720-2019·2019-06-12

    Centurion Medical Recalls Sterile Nail Nippers Due to Compromised Seal

    Centurion Medical Products Corporation is recalling sterile nail nippers because the sterile barrier pouch seal is compromised, potentially affecting sterility.

    Product
    Sterile Nail Nipper, Barrel Spring (I68400), Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1652-2019·2019-06-05

    Maquet Getinge E-Circuit Bioline Heparin Tubing Sets Recalled for Sterility Concerns

    Maquet Cardiovascular is recalling specific batches of BEQ-TOP 37200 E-Circuit Bioline Heparin tubing sets because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge- BEQ-TOP 37200 E-Circuit Bioline Heparin Material: 701055388R01
    Category
    Medical Device
    Distribution
    Distributed nationwide