CLASS II ONGOING Device recall · Reported 7 Jun 2023 · FDA Enforcement Report
Quadrox-iD Adult, Oxygenator used during cardiopulmonary bypass recalled
Maquet Medical Systems U is recalling Quadrox-iD Adult, Oxygenator used during cardiopulmonary bypass, distributed nationwide in the US. The recall was initiated on 18 May 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1656-2023
- FDA event ID
- 92006
- Recalling firm
- Maquet Medical Systems U, Wayne, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 18 May 2023
- FDA classified
- 30 May 2023
- Reported
- 7 Jun 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 18 May 2023 | Recall initiated by company | |
| 30 May 2023 | Classified by FDA | +12 days |
| 7 Jun 2023 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis, and ischemia.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass Model Item No. HMOD 70000-USA 701067840 BEQ-HMOD70000-USA 701067859
Where it was distributed
Nationwide domestic distribution
Questions about this recall
Is Quadrox-iD Adult, Oxygenator used during cardiopulmonary bypass recalled?
Yes. Maquet Medical Systems U recalled Quadrox-iD Adult, Oxygenator used during cardiopulmonary bypass on 18 May 2023. The recall is Class II and its status is Ongoing. Recall number Z-1656-2023.
Why was it recalled?
Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis, and ischemia.
Which lots are affected?
Model Item No. UDI-DI HMOD 70000-USA 701067840 4058863019000 BEQ-HMOD70000-USA 701067859 4058863019024
Where was it sold?
Nationwide domestic distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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