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.

701–725 of 2235

  • 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…
    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-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
  • 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
  • SevereFDA (Devices)·Z-1507-2019·2019-06-05

    Maquet Getinge-BEQ-TOP 5900 Custom Tubing Sets Recalled for Sterility Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design flaw may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 5900 3/8 Quadrox iD Pack w/BB Material: 701050228
    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
  • HighFDA (Devices)·Z-1560-2019·2019-06-05

    Maquet Cardiovascular Recalls Custom Tubing Sets for Extracorporeal Circulation

    Maquet Cardiovascular is recalling custom tubing sets for extracorporeal circulation because a design flaw may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-T 27904 3/8 TRANSPORT PACK Material:701064804
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1579-2019·2019-06-05

    Maquet Getinge-T AV Manifold Recall Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific AV Manifold units for extracorporeal circulation because a design flaw may prevent proper sterilization of the stopcock ports.

    Product
    Maquet Getinge-T 41303 AV MANIFOLD FOR ECC PA Material:701066551
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1602-2019·2019-06-05

    Maquet Getinge ECC Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific ECC tubing sets because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-T 51501 Ochsner ECC Pack Material:709000113
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1562-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-T 44200 MAYO PULMONARY P Material: 701064831
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1648-2019·2019-06-05

    Maquet Getinge Quadrox iD Pack Recall Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific Quadrox iD Packs because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge- BEQ-TOP 27700 Quadrox iD Pack Material: 701054389R02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1514-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 15705 Material: 701051122
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1641-2019·2019-06-05

    Maquet Neonate ECC Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific neonate extracorporeal circulation tubing sets because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 28601 NEONATE ECC QPiD Material: 701051935R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1673-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific Custom Tubing Sets for Extracorporeal Circulation because the stopcock design may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge- BO-T 2303 3/8" x 3/8" Adult Pack Material: 709000004R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1646-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge: (1) Material: 701053941R01 BEQ-TOP 9005 3/8 Custom Pk w/RF32 & HMOD (2) Material: 701053941R02- BEQ-TOP 9005 3/8 Custom Pk w RF32 & HMOD Material:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1601-2019·2019-06-05

    Maquet Getinge Adult ECC Pack Recall Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling Adult ECC Packs because a design feature may prevent sterilization gas from reaching all fluid paths, potentially compromising sterility.

    Product
    Maquet Getinge-BO-TOP 28903 Adult ECC Pack Material: 709000093
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1642-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 25500 ECC 3/8 in AV Loop w Qx-iD Material: 701052461R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1381-2019·2019-05-29

    Dornier Diode Laser Fibers Recalled for Sterility Compromise

    Dornier Medtech America is recalling 400 units of Dornier Diode Laser Fibers due to pin hole package failures that compromise product sterility.

    Product
    Dornier Diode Laser Fibers:Used with Dornier Medilas D Family Lasers Part Number/Description: K1001291 600 micron single use fiber K2011824 600 micron single use fiber K1001293 600 micron single use fiber K2011826 600 micron 5X reusable fiber K1008084 600 micron single use…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1336-2019·2019-05-22

    Shippert Medical Technologies Recalls Tissu-Trans Syringe Fill 360 Due to Pouch Integrity Concerns

    Shippert Medical Technologies is recalling Tissu-Trans Syringe Fill 360 devices because the sterile pouch integrity cannot be assured without visual examination.

    Product
    Tissu-Trans Syringe Fill 360, Catalog 3-TT-SFILL 360, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1332-2019·2019-05-22

    Shippert Medical Technologies Recalls Tissu-Trans FILTRON 500 Due to Pouch Integrity Concerns

    Shippert Medical Technologies is recalling Tissu-Trans FILTRON 500 sterile pouches because a cut or hole in the packaging may compromise the product's sterility.

    Product
    Tissu-Trans FILTRON 500, Catalog 3-TT-FILTRON 500, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1335-2019·2019-05-22

    Shippert Medical Technologies Recalls Tissu-Trans MEGA 1500 Due to Pouch Integrity Concerns

    Shippert Medical Technologies is recalling Tissu-Trans MEGA 1500 sterile pouches because a cut or hole may compromise sterility.

    Product
    Tissu-Trans MEGA 1500, Catalog 3-TT-MEGA 1500, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1331-2019·2019-05-22

    Shippert Medical Technologies Recalls Tissu-Trans FILTRON 250 Due to Pouch Integrity Concerns

    Shippert Medical Technologies is recalling Tissu-Trans FILTRON 250 sterile filters because the pouch integrity cannot be assured without visual examination.

    Product
    Tissu-Trans FILTRON 250, Catalog 3-TT-FILTRON 250, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1308-2019·2019-05-15

    ConMed Anchor Tissue Retrieval System Recalled for Seal Defects

    Conmed Corporation is recalling specific lots of the Anchor Tissue Retrieval System because seal defects may compromise the product's sterility.

    Product
    ConMed Anchor Tissue Retrieval System, 8 MM, 125 ML (5/BX) Catalog Number:TRS-ROBO-8 The Anchor Tissue Retrieval System" by CONMED is a sterile disposable pouch used with a dedicated introducer for the encapture and removal of an organ or tissue from the body cavity during…
    Category
    Medical Device
    Distribution
    Distributed nationwide