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.

776–800 of 1693

  • HighFDA (Devices)·Z-1548-2019·2019-06-05

    Maquet Getinge-BEQ-TOP 26402 ECC Pack Recall Due to Sterility Concerns

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

    Product
    Maquet Getinge-BEQ-TOP 26402 ECC PACK Material: 701062310
    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-1649-2019·2019-06-05

    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.

    Product
    Maquet Getinge- BEQ-TOP 32100 Adult Custom Pack Material:701054438R01
    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-1533-2019·2019-06-05

    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 32100 ADULT CUSTOM PAC Material:701054438
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1552-2019·2019-06-05

    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 proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 30901 CUSTOM CPB PACK Material:701063071
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1645-2019·2019-06-05

    Maquet Custom Tubing Sets Recalled for Sterility Assurance Concerns

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

    Product
    Maquet Getinge-BEQ-TOP 250011/4 1/4 Less than 20 kg up Material: 701053906R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1603-2019·2019-06-05

    Maquet Getinge ECC Tubing Sets Recalled for Sterility Assurance Concerns

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

    Product
    Maquet Getinge-BEQ-T 51502 Ochsner ECC Ancillary Pack Material:709000115
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1569-2019·2019-06-05

    Maquet Getinge ECC Tubing Sets Recalled for Sterility Assurance Concerns

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

    Product
    Maquet Getinge-BEQ-TOP 27609 ECC PACK 1/4" Material: 701065504
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1503-2019·2019-06-05

    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 configuration may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-T-22800 Material: 701049506
    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-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-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-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-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-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-1604-2019·2019-06-05

    Maquet Getinge Cardioplegia Packs Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific batches of Getinge-BO-T 52360 Cardioplegia Packs because a design feature may prevent proper sterilization of the stopcock ports.

    Product
    Maquet Getinge-BO-T 52360 Cardioplegia Pack Material: 709000127
    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-1540-2019·2019-06-05

    Maquet Getinge ECC Tubing Sets Recalled for Sterility Assurance Concerns

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

    Product
    Maquet Getinge-BEQ-TOP 37500 ECC QUADROX ID Material: 701055601
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1522-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns

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

    Product
    Maquet Getinge-BO-TOP 30300 Material:701052623
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1658-2019·2019-06-05

    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 the stopcock ports.

    Product
    Maquet Getinge- (1) Material: 701063255R01 BEQ-TOP 25003 3/8 3/8 up to 7lpm (2) Material: 701063255R02 BEQ-TOP 25003 3/8 3/8 up to 7 lpm
    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-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-1554-2019·2019-06-05

    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 25003 3/8X3/8 TO 7LPM Material: 701063255
    Category
    Medical Device
    Distribution
    Distributed nationwide