Class II — SenTec AG
| Recalling firm | Sentec, Inc. |
|---|---|
| Registered facility | SENTEC, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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. |
| Product | 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 |
| Distribution | US Nationwide distribution. |
| Initiated | 2023-07-25 |
| Classified | 2023-09-15 |
| Recall number | Z-2592-2023 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — SenTec AG (Z-2592-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/92833/
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