# FDA recall Z-2592-2023

> **SenTec AG** · Class II · device recall initiated 2023-07-25.

## 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.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-2592-2023
- **Recalling firm:** SenTec AG
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-07-25
- **Report date:** 2023-09-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Therwil, Switzerland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2592-2023

## Citation

> AI Analytics. FDA recall Z-2592-2023. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-2592-2023. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*