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.

Which agencies issued them

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.

651–675 of 2228

  • ModerateFDA (Devices)·Z-2415-2019·2019-09-04

    Stryker Recalls Endotrac ECTR Hook Blades Due to Seal Integrity Concerns

    Stryker GmbH is recalling 1,959 Endotrac ECTR Hook Blades because the sterile bag seal may be compromised, potentially affecting sterility.

    Product
    Endotrac ECTR Hook Blade, Catalog Number 2055-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocnemiu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2420-2019·2019-09-04

    Stryker Recalls Endotrac ECTR Triangle Blades Due to Seal Integrity

    Stryker GmbH is recalling 94 Endotrac ECTR Triangle Blades because the sterile bag seal may be compromised, potentially affecting sterility.

    Product
    Endotrac ECTR Triangle Blade, Angled, Catalog Number 2054A-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2417-2019·2019-09-04

    Stryker Endotrac Triangle Blade Recall Due to Compromised Sterile Bag Seal

    Stryker GmbH is recalling 1,533 Endotrac EPF/EGR Triangle Blades because the sterile bag seal integrity may be compromised, potentially affecting sterility.

    Product
    Endotrac EPF/EGR Triangle Blade, Catalog Number 3054-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2423-2019·2019-09-04

    Stryker Endotrac Hook Blade Recalled for Compromised Sterile Bag Seal

    Stryker GmbH is recalling 110 units of Endotrac EPF/EGR Hook Blades because the sterile bag seal integrity may be compromised.

    Product
    Endotrac EPF/EGR Hook Blade, Angled, Catalog Number 3055A-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2412-2019·2019-09-04

    Stryker Recalls Endotrig ETF Hook Blades Due to Sterile Seal Concerns

    Stryker GmbH is recalling 35 Endotrig ETF Hook Blades because the sterile bag seal integrity may be compromised, potentially affecting sterility.

    Product
    Endotrig ETF Hook Blade, Catalog Number 1052-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocnemius
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2424-2019·2019-09-04

    Stryker Recalls Endintrak 2 Hook Blade Kits Due to Seal Integrity

    Stryker GmbH is recalling 259 Endintrak 2 Hook Blade kits because the sterile bag seal integrity may be compromised, potentially affecting sterility.

    Product
    Endintrak¿ 2 Hook Blade, Angled, Catalog Number 4058A-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gast
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2414-2019·2019-09-04

    Stryker Endotrac ECTR Triangle Blade Recalled Due to Compromised Sterile Bag Seal

    Stryker GmbH is recalling 53 Endotrac ECTR Triangle Blades because the sterile bag seal may be compromised, potentially affecting sterility.

    Product
    Endotrac ECTR Triangle Blade, Catalog Number 2054-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocn
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2358-2019·2019-09-04

    Medline Recalls Sterile Piston Irrigation Syringe Trays Due to Packaging Defects

    Medline Industries is recalling 11,962 sterile piston irrigation syringe trays because samples showed incomplete or open packaging seals.

    Product
    Medline SYRINGE, PISTON,IRR TRAY,W/.9, REF DYNC2303. Sterile Piston Irrigation Syringe Tray with Saline
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2340-2019·2019-08-28

    Pro-Dex Surgical Driver Battery Packs Recalled for Visual Particulates

    Pro-Dex Inc is recalling sterile surgical driver battery packs due to visual particulates found within the Tyvek pouches.

    Product
    PRO-DEX Surgical Driver Battery Pack PDBP-001 Series PRO-DEX Battery Pack, Single Pouch - PDBP-001-2 PRO-DEX Battery Pack, 40 Pouches - PDBP-040-2 Product Usage: -The PDBP-001 Battery is a single use (non-rechargeable) sterile lithium ion battery accessory that powers the P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2240-2019·2019-08-21

    BioPro K-Wire Sterile Single Trochar Recalled for Sterile Barrier Flaw

    BioPro, Inc. is recalling K-Wire Sterile Single Trochar units due to a manufacturing flaw in the sterile barrier system that may compromise sterility.

    Product
    K-Wire Sterile Single Trochar, Item Number 19106 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2237-2019·2019-08-21

    Santanello VAMPIRO V5001 Suction Sleeve Recalled for Package Integrity Issues

    Santanello Surgical LLC is recalling 98 VAMPIRO V5001 suction sleeves because package integrity issues may compromise sterility.

    Product
    VAMPIRO V5001-minimally invasive poole suction sleeve that is an accessory instrument to ANY 5mm spot suction/irrigation catheter
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2162-2019·2019-08-14

    Centurion Medical Products Recalls Sterile Fluoro SSP Trays Due to Packaging Concerns

    Centurion Medical Products is recalling 400 sterile fluoro SSP trays because the sterile packaging may be compromised. The kits are used for arthrogram injection and aspiration.

    Product
    STERILE FLUORO SSP TRAY Kit Code: MNS11605 - Product Usage: This kit is used for arthrogram injection and aspiration. The kits are used in the diagnostic section of the radiology department, by medical professionals in a clinical setting.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2164-2019·2019-08-14

    Centurion Medical Recalls Circumcision Kits Due to Sterile Packaging Concerns

    Centurion Medical Products Corporation is recalling 168 Circumcision Tray kits because sterile packaging may be compromised. The kits are used for newborn circumcision procedures.

    Product
    CIRCUMCISION TRAY Kit Code: CIT2650H - Product Usage: Kit is used for performing circumcision procedures on newborns.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2172-2019·2019-08-14

    Centurion Laceration Tray Kits Recalled for Potential Sterile Packaging Compromise

    Centurion Medical Products is recalling Laceration Tray Kits because sterile packaging may be compromised, posing a risk of infection.

    Product
    LACERATION TRAY Kit Code: SUT18370 - Product Usage: Kit is used for laceration repairs for general population.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2170-2019·2019-08-14

    Centurion Driveline Management System 1 Daily Kit Recalled for Packaging Risk

    Centurion Medical Products is recalling 6,180 Driveline Management System 1 Daily Kits because sterile packaging may be compromised.

    Product
    DRIVELINE MANAGEMENT SYSTEM 1 DAILY Kit Code: DT18440A - Product Usage: Kit is used for Driveline Maintenance and Securement of Line for general patient population.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2046-2019·2019-07-31

    Cardinal Health Recalls Monoject 201 Vet Pak Hypodermic Needles

    Cardinal Health is recalling specific lots of 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, 18 ga x 1-1/2 Item code: 8881201548
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2042-2019·2019-07-31

    Cardinal Health Recalls Monoject Hypodermic Needles Due to Sterility Concerns

    Cardinal Health 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, 20 G x 1-1/2" bulk Item code: 8881200664
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2049-2019·2019-07-31

    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, 16 G x 1-1/2" (1.651 mm x 3.8 cm) Item code: 8881202322
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2051-2019·2019-07-31

    Cardinal Health Recalls Monoject Blunt Cannula Due to Sterility Barrier Defect

    Cardinal Health 200, LLC is recalling Monoject Blunt Cannula, 20 G x 1-1/2" (Item code: 8881202363), because a manufacturing defect in the cartridge component could compromise the product's sterility barrier.

    Product
    Monoject Blunt Cannula, 20 G x 1-1/2" (0.902 mm x 3.8 cm) Item code: 8881202363
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2036-2019·2019-07-31

    Cardinal Health Recalls Monoject Hypodermic Needles Due to Sterility Defect

    Cardinal Health 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, 14 G x 1-1/2" Item code: 8881200011
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2054-2019·2019-07-31

    MOOG Curlin Infusion Administration Sets Recalled for Filter Leaks

    Zevex Incorporated is recalling specific lots of MOOG Curlin Infusion Administration Sets because they leaked at the filter.

    Product
    MOOG Curlin Infusion Administration Set, REF 340-4130-V, Non-DEHP Tubing with Non-Vented Bag Spike and Vented 0.2 Micron Filter with add-on check valve, packaged 20 sets/carton, sterile. The firm name on the label is ZEVEX, Inc., Salt Lake City, UT.
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-2048-2019·2019-07-31

    Cardinal Health Recalls Monoject Blunt Cannulas Due to Sterility Barrier Defect

    Cardinal Health 200, LLC is recalling Monoject Blunt Cannulas because a manufacturing defect in the cartridge component could compromise the product's sterility barrier.

    Product
    Monoject Blunt Cannula, 15 G x 1-1/2" (1.829 mm x 3.8 cm) Item code: 8881202314
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2041-2019·2019-07-31

    Cardinal Health Recalls Monoject Hypodermic Needles Due to Sterility Concerns

    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, 27 G x 1-1/4" Item code: 8881200508
    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