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.

701–725 of 2228

  • 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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-1304-2019·2019-05-15

    ConMed Anchor Tissue Retrieval System Recalled for Seal Defects

    ConMed is recalling Anchor Tissue Retrieval Systems because voids or partial seals may compromise sterility. The recall covers units distributed worldwide.

    Product
    ConMed Anchor Tissue Retrieval System 10 MM, 235 ML, (5/BX) Catalog Number: TRS100SB2 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
  • 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 l
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1307-2019·2019-05-15

    ConMed Anchor Tissue Retrieval System Recalled for Seal Defects

    Conmed Corporation is recalling the Anchor Tissue Retrieval System due to seal defects that may compromise sterility.

    Product
    ConMed Anchor Tissue Retrieval System, VATS, 15 MM, 1550 ML (3/BX) Catalog Number: TRS-VATS-15 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 cavit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1306-2019·2019-05-15

    ConMed Anchor Tissue Retrieval System Recalled for Sterility Seal Defects

    ConMed is recalling Anchor Tissue Retrieval Systems due to seal defects that may compromise sterility. The recall covers 5,034 units distributed worldwide.

    Product
    ConMed Anchor Tissue Retrieval System, 15 MM, 1850 ML (3/BX) Catalog Number:TRS190SB2 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
  • HighFDA (Devices)·Z-1309-2019·2019-05-15

    ConMed Anchor Tissue Retrieval System Recalled for Seal Defects

    Conmed Corporation is recalling Anchor Tissue Retrieval Systems due to seal defects that may compromise sterility. The recall affects 7,930 units distributed in the US and 13 other countries.

    Product
    ConMed Anchor Tissue Retrieval System", 12 MM, 300 ML (5/BX) Catalog Number: TRS-ROBO-12 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 duri
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1305-2019·2019-05-15

    ConMed Anchor Tissue Retrieval System Recalled for Seal Defects

    ConMed is recalling Anchor Tissue Retrieval Systems because voids or partial seals may compromise the sterility of the product.

    Product
    ConMed Anchor Tissue Retrieval System 15 MM, 1550 ML (3/BX) Catalog Number: TRS175SB2 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
  • HighFDA (Devices)·Z-1046-2019·2019-04-03

    Avitus Bone Harvester Recalled for Potential Sterility Compromise

    Avitus Orthopaedics is recalling 508 Bone Harvester units because a breach in the sterile barrier pouch may compromise the device's sterility.

    Product
    Avitus¿ Bone Harvester w/ Filter Insert - 8mm intended to harvest cancellous bone and bone marrow Catalog Number: BH-110 The Avitus¿ Bone Harvester is intended to harvest cancellous bone and bone marrow
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1047-2019·2019-04-03

    Avitus Bone Harvester Recalled for Potential Sterility Compromise

    Avitus Orthopaedics is recalling 207 Bone Harvesters due to a breach in the sterile barrier pouch that may compromise device sterility.

    Product
    Avitus¿ Bone Harvester w/ Filter Insert - 5mm intended to harvest cancellous bone and bone marrow Catalog Number: BH-210 The Avitus¿ Bone Harvester is intended to harvest cancellous bone and bone marrow
    Category
    Medical Device
    Distribution
    Distributed nationwide