Membrane Changer Single-Use — Class II medical device recall Z-2592-2023
Ongoing recall by SenTec AG, reported 2023-09-27, distributed nationwide. During rework of components during the manufacturing process, an additional piece of material may have been le
| Recall number | Z-2592-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SenTec AG, Therwil, Switzerland |
| Recall initiated | 2023-07-25 |
| Classified | 2023-09-15 |
| Reported by FDA | 2023-09-27 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 07640121880087, 07640121880506, 07640121880933, 17640121880084, 17640121880503, 17640121880930, 27640121880081 |
| Model numbers | 221056, 221064, 225006, 225023, 225033, 225058, 225063, 225064, 225073, 225088, 225089, 225091, 225119, 225120, 225122, 225126, 225147, 225149, 225173, 225175, 225183, 225184, 225185, 225190, 225216 and 38 more |
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).
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2592-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.