SenTec Membrane Changer — Class II medical device recall Z-2152-2019
Terminated recall by SenTec AG, reported 2019-08-14, distributed nationwide. There is an increased chance (approx. 5%) of no electrolyte or a reduced amount of electrolyte being applied t
| Recall number | Z-2152-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SenTec AG, Therwil, N/A, Switzerland |
| Recall initiated | 2019-05-02 |
| Classified | 2019-08-05 |
| Reported by FDA | 2019-08-14 |
| Terminated | 2020-12-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, CH, CL, CN, CR, CZ, DE, DK, EC, ES, FI, FR, GB, GR, GT, HK, HU, ID, IL, IT, KR, KW, LK, MY, PT, RO, RU, SA, SG, TH, TW |
| Quantity | 198 units |
| Lot numbers | 180763, 180834, 180872, 180874, 180876, 180970, 180993, 181011, 181016, 181031, 181034, 181045, 181072, 181087, 181103, 181141, 190080, 190141, 190165, 190203, 190210, 190264 |
Product
SenTec Membrane Changer (reloadable) [9 pcs] - Product Usage: Is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia.
Reason for recall
There is an increased chance (approx. 5%) of no electrolyte or a reduced amount of electrolyte being applied to the sensor during the membrane change procedure.
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-2152-2019. 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.