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.

751–775 of 1691

  • HighFDA (Devices)·Z-1539-2019·2019-06-05

    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 sterilization gas from reaching all fluid paths.

    Product
    Maquet Getinge-BEQ-TOP 37200 CIRCULATORY CIRC Material: 701055388
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1590-2019·2019-06-05

    Maquet Getinge-BEQ-T 3501 LVAD Tubing Sets Recalled for Sterility Assurance Issues

    Maquet Cardiovascular is recalling specific LVAD tubing sets because a design feature may prevent sterilization gas from reaching all parts, compromising sterility.

    Product
    Maquet Getinge-BEQ-T 3501 LVAD/ 3/8" Material: 701068008
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1606-2019·2019-06-05

    Maquet Getinge-BEQ-T 8506 Transport Pack Recalled for Sterility Assurance Issues

    Maquet Cardiovascular is recalling Custom Tubing Sets for Extracorporeal Circulation because the stopcock design may prevent sterilization gas from reaching the fluid path, compromising sterility.

    Product
    Maquet Getinge-BEQ-T 8506 Transport Pack Material: 709000146
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1570-2019·2019-06-05

    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 31203 CUSTOM PACK NEO Material: 701065510
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1628-2019·2019-06-05

    Maquet Pediatric Extracorporeal Circulation Tubing Sets Recalled for Sterility Concerns

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

    Product
    Maquet Getinge-BEQ-T 4932 Mercy Adaptation Pk Pediatric Material:709000520
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1616-2019·2019-06-05

    Maquet Getinge Adult Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling Adult 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-T 27602 709000417 Adult Custom Pack Material: 709000417
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1549-2019·2019-06-05

    Maquet Getinge ECC Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific batches of 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-T 39700 ECC PACK Material:701062473
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1546-2019·2019-06-05

    Maquet Pediatric CPB Packs Recalled for Sterility Assurance Concerns

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

    Product
    Maquet Getinge-BEQ-T 4906 PEDIARIC CPB PACK Material: 701056041
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1581-2019·2019-06-05

    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-T 4903 Mercy Med w/o Oxy Material:701066664
    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-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-1529-2019·2019-06-05

    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 of stopcock ports.

    Product
    Maquet Getinge-BEQ-TOP 33700 ECC 3/8" PACK Material: 701053845
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1600-2019·2019-06-05

    Maquet Pediatric ECC Tubing Sets Recalled for Sterility Assurance Concerns

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

    Product
    Maquet Getinge-BEQ-TOP 50903 Custom ECC Pack-Pedriatric Material: 709000078
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1617-2019·2019-06-05

    Maquet Getinge Rotaflow Pack Recalled Due to Sterility Assurance Concerns

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

    Product
    Maquet Getinge-BEQ-T 57000 Rotaflow Pack Material: 709000424
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1585-2019·2019-06-05

    Maquet Getinge-BEQ-TOP 5208 ECC Set Cardiac Recall for Sterility Assurance

    Maquet Cardiovascular is recalling specific batches of cardiac extracorporeal circulation sets because a design flaw may prevent proper sterilization of the stopcock ports.

    Product
    Maquet Getinge-BEQ-TOP 5208 ECC SET CARDIAC Material: 701067350
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1558-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns

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

    Product
    Maquet Getinge-BEQ-T 30601 CMC ACCESSORY KIT Material: 701064701
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1605-2019·2019-06-05

    Maquet Pediatric Cardiac Surgery Tubing Sets Recalled for Sterility Assurance Concerns

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

    Product
    Maquet Getinge-BO-T 46201 Small Pediatric Cardiac Surge Material: 709000133
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1502-2019·2019-06-05

    Maquet Getinge ECC Tubing Sets Recalled Due to Sterility Assurance Concerns

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

    Product
    Maquet Getinge-BEQ-TOP 17207 3/8 ECC PACK Material: 701049346
    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-1498-2019·2019-06-05

    Maquet Getinge Tubing Packs Recalled Due to Sterility Assurance Concerns

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

    Product
    Maquet Getinge-BEQ-TOP 15800 TUBING PACK Material: 3000065087
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1635-2019·2019-06-05

    Maquet Getinge Small Patient ECC Pack Recall for Sterility Assurance Issues

    Maquet Cardiovascular is recalling Small Patient ECC Packs because a design flaw may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge- BEQ-TOP 24100 Small Patient ECC Pack Material:701050175R02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1618-2019·2019-06-05

    Maquet Getinge-T 5220 UAB Hospital Accessory Recall for Sterility Assurance Concerns

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

    Product
    Maquet Getinge-T 5220 UAB Hospital Accessory Material: 709000426
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1589-2019·2019-06-05

    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, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 50100 CHOSA 1/4" ECC PACK Material: 701067837
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1534-2019·2019-06-05

    Maquet Getinge AV Loop Tubing Recalled Due to Sterility Assurance Concerns

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

    Product
    Maquet Getinge-BEQ-TOP 21503 ECC 1/4" AV LOOP Material:701054776
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1608-2019·2019-06-05

    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 52301 ¿ Sash & Accessory Pack Material: 709000266
    Category
    Medical Device
    Distribution
    Distributed nationwide