Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Membrane Changer Single-Use Recalled by SenTec AG Due to During rework of components during the manufacturing process,...
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 SenTec AG directly.
Affected Products
Membrane Changer Single-Use, REF MC, each package contains 3 changers; Membrane Changer Reloadable, REF MC-R, each package contains 3 changers; and Membrane Changer Insert, REF MC-I, each package contains 5 inserts. All are components of the Sentec Digital Monitoring System (SDMS).
Quantity: REVISED 9/21/2023-15,065 packages
Why Was This Recalled?
During rework of components during the manufacturing process, an additional piece of material may have been left in the device, which may result in an impact on measurement performance.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About SenTec AG
SenTec AG has 11 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report