The Recall Desk

Hazard

Sterility Failure recalls

1,693 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,693
Critical
12
Severe
938
Most recent
2026-09-30

Of the 1,693 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 938 (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.

801–825 of 1693

  • HighFDA (Devices)·Z-1512-2019·2019-06-05

    Maquet Getinge-BO-TOP 20700 Small Patient Tubing Sets Recalled for Sterility Concerns

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

    Product
    Maquet Getinge-BO-TOP 20700 SMALL PATIENT 3/8 Material: 701050966
    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-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-1654-2019·2019-06-05

    Maquet Getinge BEQ-TOP 5210 ECC Set Recall for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific BEQ-TOP 5210 ECC Sets because a design flaw may prevent proper sterilization of the stopcock ports.

    Product
    Maquet Getinge- BEQ-TOP 5210 ECC Set - Respiratory Material: 701055604R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1659-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific batches of BO-TOP 48400 OR PACK tubing sets because a design flaw may prevent proper sterilization of the stopcock ports.

    Product
    Maquet Getinge BO-TOP 48400 OR PACK Material: 701064327R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1524-2019·2019-06-05

    Maquet Getinge ECC Tubing Sets Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific batches of Getinge-BEQ-TOP 32200 ECC Packs because a design feature may prevent proper sterilization of the stopcock ports.

    Product
    Maquet Getinge-BEQ-TOP 32200 ECC PACK - Material: 701053319
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1657-2019·2019-06-05

    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 39700 ECC Pack Material:701062473R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1612-2019·2019-06-05

    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 4917 Mercy Medical Versa-Pack Material: 709000368
    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-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-1639-2019·2019-06-05

    Maquet Getinge Circulatory Circuits Recalled Due to Sterility Assurance Concerns

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

    Product
    Maquet Getinge-BEQ-TOP 15704 Circulatory Circuit 3/8" Material:701050859R01
    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
  • HighFDA (Devices)·Z-1527-2019·2019-06-05

    Maquet Getinge ECC Tubing Sets Recalled for 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-BEQ-TOP 33500 3/8" ECC PACK Material: 701053752
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1626-2019·2019-06-05

    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 sterilization gas from reaching all fluid paths.

    Product
    Maquet Getinge-BEQ-TOP 31603 CHKD 3/8" ECC Material: 709000516
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1501-2019·2019-06-05

    Maquet Getinge Tubing Packs Recalled Due to Sterility Assurance Concerns

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

    Product
    Maquet Getinge-BEQ-TOP 5103#CPS Tubing Pack Material: 701048690
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1499-2019·2019-06-05

    Maquet Cardiovascular Recalls Custom Tubing Sets for Extracorporeal Circulation

    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 8013 ECC QUADROX iD Pack RF32 Material: 701047962
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1508-2019·2019-06-05

    Maquet Getinge Adult ECC Tubing Sets Recalled for Sterility Assurance Concerns

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

    Product
    Maquet Getinge-BEQ-TOP 24500 ADULT ECC Material: 701050253
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1586-2019·2019-06-05

    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-TOP 14605 OPEN HEART WITHOU Material: 701067372
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1510-2019·2019-06-05

    Maquet Getinge-BEQ-TOP 4901 Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific Custom Tubing Sets for Extracorporeal Circulation because a design feature may prevent sterilization gas from reaching all fluid paths.

    Product
    Maquet Getinge-BEQ-TOP 4901 Material: 701050839
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1640-2019·2019-06-05

    Maquet Getinge ECC Tubing Sets Recalled Due to 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-TOP 5502 ECC Pack Material:701051791R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1556-2019·2019-06-05

    Maquet Getinge ECC Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific batches of Getinge-BEQ-T 5211 Large ECC Sets because a design feature may prevent proper sterilization.

    Product
    Maquet Getinge-BEQ-T 5211 LARGE ECC SET Material:701064560
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1580-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled for 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 47800 STRINGFELLOW PED Material:701066583
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1653-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns

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

    Product
    Maquet Getinge- (1) Material: 701055490R01 BEQ-TOP 15801 ¿ inch ECC Pack (2) Material :701055490R02 BEQ-TOP 15801 1/4 in ECC Pack
    Category
    Medical Device
    Distribution
    Distributed nationwide