Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
BEQ-RF-32-USA RotaFlow Centrifugal Pump with BIOLINE Coating Recalled by Maquet Medical Systems USA Due to Nonconformities at their seal could potentially compromise 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-RF-32-USA RotaFlow Centrifugal Pump with BIOLINE Coating, Product Code 701047554. For use with an extracorporeal cardiovascular or cardiopulmonary bypass circuit.
Quantity: 1090 total
Why Was This Recalled?
Nonconformities at their seal could potentially compromise the sterile barrier for affected products. Breach of sterile barrier could expose patients to pathogenic agents, resulting in the following potential harms: inflammation, infection, or sepsis.
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