Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
BEQ-HLS 7050 USA Recalled by Maquet Medical Systems USA Due to The Emergency Priming Line, a component of the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Maquet Medical Systems USA directly.
Affected Products
BEQ-HLS 7050 USA, HLS Set Advanced 7.0, Product Code/Part Number 70106.9078. Used with the CARDIOHELP heart-lung machine.
Quantity: 16520 worldwide; 6657 US
Why Was This Recalled?
The Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier due to nonconformities at the bag seal. This issue may result in inflammation, sepsis, or infection.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Maquet Medical Systems USA
Maquet Medical Systems USA has 40 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report