FDA Recalls QUADROX-i Small Oxygenator Due to Packaging Integrity Issues
Maquet Medical Systems USA is recalling 1,784 QUADROX-i Small Oxygenators due to packaging defects that may compromise the sterile barrier, risking infection and other serious complications.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall involving packaging defects that may compromise the sterile barrier of oxygenators used in critical cardiopulmonary bypass surgery. While no reported injuries or deaths are mentioned in the source, the potential consequences—infection, sepsis, and ischemia—are serious. Per the rubric, risk-of-harm products without reported injury receive a High severity score.
Plain-English summary
Maquet Medical Systems USA is recalling 1,784 QUADROX-i Small Oxygenators (Item no. 701067905, UDI-DI: 04058863019079, all lots) used during cardiopulmonary bypass procedures. The devices are being recalled due to packaging manufacturing defects that may compromise the sterile barrier.
Two issues have been identified during the manufacturing and packaging process. First, an accessory may be improperly placed during packaging, causing creases and damage to the sterile pouch. Second, the product packaging itself may exhibit holes, cracks, dents, or crushed areas. Both types of defects can compromise the integrity of the sterile barrier.
A compromised sterile barrier may allow the product to be exposed to non-sterile conditions during storage and handling. This exposure could result in inflammation, infection, sepsis, or ischemia. These are serious potential complications for patients undergoing cardiopulmonary bypass surgery, a critical cardiac procedure requiring sterile equipment.
The recalled devices were distributed nationwide in the United States. This is a Class II recall issued by the FDA.
The recalled product
- Product
- BEQ-HMO 50000-USA/ QUADROX-i Small, Oxygenator used during cardiopulmonary bypass Item no. 701067905
- Manufacturer
- Maquet Medical Systems USA
- Hazard
- sterile-barrier-compromise
- infection
- sepsis
- ischemia
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: 04058863019079 All lots
Distribution
Distributed nationwide across the United States.
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