CLASS II ONGOING Device recall · Reported 7 Jun 2023 · FDA Enforcement Report
Quadrox-iR, used during cardiopulmonary bypass recalled
Maquet Medical Systems USA is recalling Quadrox-iR, 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-1643-2023
- FDA event ID
- 92003
- Recalling firm
- Maquet Medical Systems USA, Wayne, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 18 May 2023
- FDA classified
- 26 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 | |
| 26 May 2023 | Classified by FDA | +8 days |
| 7 Jun 2023 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromise the sterile barrier of the packaging, and exposure to non-sterile product 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-iR, used during cardiopulmonary bypass Model Item No. Description BEQ-HMO 51100-USA 701067936 Small Adult with filter, with BIOLINE Coating BEQ-HMO 71100-USA 701067880 Adult with filter, with BIOLINE Coating HMO 50100-USA 701067934 Small Adult without filter, with SOFTLINE Coating HMO 51100-USA 701067938 Small Adult with filter, with SOFTLINE Coating HMO 70100-USA 701067874 Adult without filter, with SOFTLINE Coating HMO 71100-USA 701067886 Adult with filter, with SOFTLINE Coating
Where it was distributed
Domestic distribution nationwide.
Questions about this recall
Why was it recalled?
1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromise the sterile barrier of the packaging, and exposure to non-sterile product may result in inflammation, infection, sepsis, and ischemia.
Which lots are affected?
Model Item No. UDI-DI BEQ-HMO 51100-USA 701067936 n/a BEQ-HMO 71100-USA 701067880 4058863164052 HMO 50100-USA 701067934 n/a HMO 51100-USA 701067938 n/a HMO 70100-USA 701067874 n/a HMO 71100-USA 701067886 n/a All lots
Where was it sold?
Domestic distribution nationwide.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
9 other products · FDA event 92003This product is part of a recall event; the main page for the event is Quadrox-i Pediatric, Oxygenator used during cardiopulmonary bypass recalled.
More recalls from Maquet Medical Systems USA
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|---|---|---|---|---|---|
| Device | CLASS II | Cardiohelp-i System recalled by Maquet Medical Systems U | Maquet Medical Systems USA | Packaging Defects | Nationwide |
| Device | CLASS II | Model No. Beq-hls 5050 USA, HLS Set Advanced 5.0, Product Code/Part recalled | Maquet Medical Systems USA | Sterility | Nationwide |
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| Device | CLASS II | Beq-rf-32-Usa RotaFlow Centrifugal Pump recalled | Maquet Medical Systems USA | Sterility | Nationwide |
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