The Recall Desk

Hazard

Sterility Failure recalls

1,691 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,691
Critical
12
Severe
931
Most recent
2026-07-29

Of the 1,691 sterility failure recalls we have scored against our rubric, 12 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 931 (55%) 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 failure 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.

776–800 of 1691

  • HighFDA (Devices)·Z-1611-2019·2019-06-05

    Maquet Getinge-T 8030 High Flow Pigtail Tubing Recalled for Sterility Assurance Issues

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

    Product
    Maquet Getinge-T 8030 4 in High Flow Pigtail Material: 709000366
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1598-2019·2019-06-05

    Maquet Getinge ECC Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific batches of ECC tubing sets because a design feature may prevent sterilization gas from reaching all fluid paths.

    Product
    Maquet Getinge-BEQ-TOP 49103 ECC Pack 0 No Bladder Material: 709000058
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1593-2019·2019-06-05

    Maquet Getinge-BEQ-TOP 35503 SGD Pack Recall 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 35503 SGD Pack Material: 701068797
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1563-2019·2019-06-05

    Maquet Getinge Mayo Pulmonary Pack Recall Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling Mayo Pulmonary Packs because a design feature may prevent sterilization gas from reaching all parts, potentially compromising sterility.

    Product
    Maquet Getinge-BO-T 44201 MAYO PULMONARY PACK Material: 701064834
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1665-2019·2019-06-05

    Maquet Getinge Children's ECC Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific Children's Large ECC Packs because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 49101 Childrens Large ECC Pack Material: 701067069R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1624-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design configuration may prevent sterilization gas from reaching all fluid paths.

    Product
    Maquet Getinge-BEQ-TOP 25503 TMC ¿ with BB & QiD Pedi Material:709000473
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1643-2019·2019-06-05

    Maquet Getinge ECC Tubing Sets Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling BEQ-TOP 32200 ECC Packs because a design flaw may prevent sterilization gas from reaching all fluid paths, compromising sterility.

    Product
    Maquet Getinge- BEQ-TOP 32200 ECC Pack Material: 701053319R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1650-2019·2019-06-05

    Maquet Custom Tubing Sets Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling custom tubing sets for extracorporeal circulation because a design flaw may prevent proper sterilization of the stopcock ports.

    Product
    Maquet Getinge-BEQ-TOP 9004 1/4 Custom Pk w/RF32 & HMOD Material: 701054451R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1644-2019·2019-06-05

    Maquet Getinge Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Getinge-BO-TOP tubing sets are being recalled because a design feature may prevent sterilization gas from reaching all parts, compromising sterility.

    Product
    Maquet Getinge-BO-TOP 20705 SMALL PATIENT 1/4 Material: 701053486R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1541-2019·2019-06-05

    Maquet Getinge-BEQ-TOP Adult Specialty Tubing Sets Recalled for Sterility Concerns

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

    Product
    Maquet Getinge-BEQ-TOP 38002 ADULT SPECIALTY Material:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1632-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled Due to Sterility Assurance Concerns

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

    Product
    Maquet Getinge-BEQ-TOP 22600 ECC QUADROX ID 3 Material:701049440R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1619-2019·2019-06-05

    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 sterilization gas from reaching all parts of the device.

    Product
    Maquet Getinge-BEQ-T 9409 Lurie Chlds Large 3/8 Material: 709000428
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1675-2019·2019-06-05

    Maquet Custom Tubing Sets Recalled Due to Sterility Assurance Concerns

    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-TOP 50903 Custom ECC Pk-Pdtrc 3/8 - Material: 709000078R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1680-2019·2019-06-05

    Maquet Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling custom tubing sets for extracorporeal circulation because a design feature may prevent sterilization gas from reaching all parts of the device.

    Product
    Maquet Getinge- BEQ-TOP 54500 BSW-McLANE 3/8 Quadrox iD Material:709000496R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1577-2019·2019-06-05

    Maquet Getinge Priming Lines Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific priming lines for extracorporeal circulation because a design feature may prevent proper sterilization gas flow, potentially compromising sterility.

    Product
    Maquet Getinge-BO-T 41302 PRIMING LINES BUMC Material:701066291
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1677-2019·2019-06-05

    Maquet Getinge Rotaflow Pack Recall Due to Sterility Assurance Concerns

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

    Product
    Maquet Getinge- BEQ-T 53500 Evanston Rotaflow Pack Material:709000215R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1504-2019·2019-06-05

    Maquet Getinge-BEQ-TOP 3700 Tubing Pack Recalled for Sterility Assurance Concerns

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

    Product
    Maquet Getinge-BEQ-TOP 3700 Tubing Pack Material: 701049510
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1663-2019·2019-06-05

    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- (1)Material: 701065765R01 BO-TOP 36504 Adult ECC Pack (2)Material: 701065765R02 BO-TOP 36504 Adult ECC Pack
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1568-2019·2019-06-05

    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 gas flow, potentially compromising sterility.

    Product
    Maquet Getinge-BO-T 41301 BUMC ECC PACK Material: 701065209
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1662-2019·2019-06-05

    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 gas flow, compromising sterility.

    Product
    Maquet Getinge- BO-T 41301 BUMC ECC PACK Material: -701065209R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1668-2019·2019-06-05

    Maquet Getinge Open Heart Pack Recall Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific Open Heart Packs because a design feature may prevent sterilization gas from reaching all parts, potentially compromising sterility.

    Product
    Maquet Getinge BEQ-TOP 40010 OPEN HEART PACK Material: -701067364R02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1627-2019·2019-06-05

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

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because the design may prevent proper sterilization gas flow, compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 31604 CHKD 1/4" ECC Material: 709000518
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1571-2019·2019-06-05

    Maquet Custom Tubing Sets Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling custom tubing sets for extracorporeal circulation because a design flaw may prevent proper sterilization of stopcock ports.

    Product
    Maquet Getinge-BEQ-TOP 31204 CUSTOM PACK PEDI Material: 701065512
    Category
    Medical Device
    Distribution
    Distributed nationwide