Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
BEQ-HLS 5050 USA Recalled by Maquet Medical Systems USA Due to Firm has initiated a removal of the product...
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 5050 USA; HLS Set Advanced 5.0, Product Code 70106.9077, BEQ-HLS 7050 USA; HLS Set Advanced 7.0, Product Code 70106.9078. Part of the CARDIOHELP System, a pre-connected set used for extracorporeal respiratory and/or cardiovascular support.
Quantity: 10,587 units (US); 94,987 (worldwide)
Why Was This Recalled?
Firm has initiated a removal of the product due to insufficient evidence of packaging sterility. Exposure to a non-sterile medical device may result in inflammation, infection, sepsis, or ischemia.
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