FDA expands recall: HLS Set Advanced 7.0 sterility barrier compromise
Maquet Medical Systems USA has expanded a recall for HLS Set Advanced 7.0, a preconnected medical device used for heart and lung support, due to a potential breach in the sterility barrier that could compromise product sterility.
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: The hazard is a potential sterility barrier breach in a life-support medical device (Class II), which poses risk of patient harm through contamination. However, the source text does not report any illnesses, injuries, or hospitalizations, and the hazard is stated as potential rather than confirmed. Per the rubric, theoretical hazards without reported injury in high-risk-of-harm products warrant a score of 3.
Plain-English summary
Maquet Medical Systems USA is recalling the HLS Set Advanced 7.0 (Part No. 70105.2794), a preconnected device used for extracorporeal respiratory and cardiovascular support as part of the CARDIOHELP System. The recall affects approximately 206 units in the United States and 48,960 units worldwide, distributed to healthcare facilities in the US, Canada, and Australia.
The manufacturer has identified a potential breach in the sterility barrier of these devices, which may compromise the product's sterility. This is an expanded recall that builds on a previous recall initiated in November 2020. The FDA classified this as a Class II recall.
Affected lot numbers include 3000183172, 3000183179, 3000183191, 3000183910, and 3000184681. Healthcare facilities should check their inventory against these lot numbers and contact Maquet Medical Systems USA for guidance on replacements or corrective actions. Patients and healthcare providers should not discontinue use of the device without consulting appropriate medical personnel regarding next steps.
The recalled product
- Product
- BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70105.2794. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System.
- Manufacturer
- Maquet Medical Systems USA
- Hazard
- sterility-breach
- contamination-risk
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 (5)
- UDI-DI: 04037691741543 Lots 3000183172
- 3000183179
- 3000183191
- 3000183910
- 3000184681
Distribution
Distributed nationwide across the United States.
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