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# FDA Alert on Oxygenator Recall
- URL: https://www.fdaweb.com/fda-alert-on-oxygenator-recall/
- Published: 2023-06-09T12:00:00.000Z
- Updated: 2026-09-14T18:38:15.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5154656

FDA is alerting health care [providers](https://www2.getinge.com/us/products/hospital/extracorporeal-life-support/?ref=fdaweb.com) and facilities on the use of oxygenators in extracorporeal circulation following a recent recall by Getinge/Maquet of its Quadrox oxygenators and certain Getinge/Maquet venous hardshell cardiotomy reservoirs due to potentially compromised packaging sterility that may result in the risk of infection and harm to patients.

The agency’s alert recommends against the use of these devices unless they are already in use. “If a Quadrox oxygenator or specified venous hardshell cardiotomy reservoir is already in use, these devices may continue to be used,” it says. “Monitor patients for the following signs and symptoms, and, if detected, treat the patient according to clinical protocols: inflammation, infection, sepsis, and ischemia.”

For new extracorporeal circulation procedures, FDA says they should use an alternative device. It also provides links to:

- [FDA-cleared oxygenators for use in cardiopulmonary bypass (CPB) circuit](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?start%5Fsearch=1&Center=&Panel=&ProductCode=DTZ&KNumber=&Applicant=&DeviceName=&Type=&ThirdPartyReviewed=&ClinicalTrials=&Decision=&DecisionDateFrom=&DecisionDateTo=06%2F06%2F2023&IVDProducts=&Redact510K=&CombinationProducts=&ZNumber=&PAGENUM=10&sortcolumn=dd%5Fdesc&ref=fdaweb.com)
- [FDA-cleared oxygenators for use in extracorporeal membrane oxygenation (ECMO) circuit](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?start%5Fsearch=1&Center=&Panel=&ProductCode=BYS&KNumber=&Applicant=&DeviceName=&Type=&ThirdPartyReviewed=&ClinicalTrials=&Decision=&DecisionDateFrom=&DecisionDateTo=06%2F06%2F2023&IVDProducts=&Redact510K=&CombinationProducts=&ZNumber=&PAGENUM=10&sortcolumn=dd%5Fdesc&ref=fdaweb.com)

Oxygenator devices are blood-gas exchangers used to provide physiological gas exchange for up to six hours during cardiopulmonary bypass procedures, or for more than six hours during extracorporeal membrane oxygenation (ECMO) procedures. The venous hardshell cardiotomy reservoir is used to collect, store and filter blood in extracorporeal circulation in cardiopulmonary bypass procedures for up to six hours.