Recall Register

Food, drugs, devices › Firms

SenTec AG

FDA recalling firm · 9 enforcement events · 14 product records · 2012–2023 · N/A

SenTec AG has 9 FDA enforcement events on this register (14 product records) between 2012 and 2023: 9 device; the busiest year was 2012 with 2.

0% of its events are Class I; the most common class is Class II (9). 2 events are listed as ongoing; the recalling firm's address is in N/A.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
25 Jul 2023Membrane 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).DeviceClass II1Ongoing
2 May 2023V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS).DeviceClass II1Ongoing
22 Aug 2022sentec 24 / MARe-SF Multi-Site Attachment Ring Easy, For sensitive / fragile skin. Used in continuous, noninvasive carbon dioxide and/or oxygen tension monitoring.DeviceClass II1Terminated
10 Dec 2020SenTec Digital Monitor, Model SDM, is a portable stand-alone patient monitor indicated for continuous, noninvasive patient monitoring of carbon dioxide partial pressure (PCo2), oxygen partial pressure (POs), functional oxygen saturation (PsO2), and pulse rate (PR), using either a single digital sensor (V-Sign Sensor…DeviceClass II1Terminated
2 May 2019SenTec 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…DeviceClass II5Terminated
15 Sep 2016SDMS (SenTec Digital Monitoring System)DeviceClass II1Terminated
25 Mar 2015Sentec, V-Sign Sensor 2 (REF VS-A/P/N), Reusable / Nonsterile / Waterproof, SenTec AG, CH-4106, Therwil, Switzerland. The SenTec Digital Monitoring System (SDMS) is used for continuous and non-invasive monitoring of transcutaneous carbon dioxide tension (tcPCO2), oxygen saturation (SpO2), and pulse rate (PR).DeviceClass II1Terminated
5 Nov 2012SenTec V-Sign Membrane Changer (VS-MC), 9 pieces. The SenTec V-Sign Membrane Changer is indicated for use with the V-Sign Sensor only. The V-sign Sensor is indicated for use with the SenTec Digital Monitor when continuous non-invasive monitoring of carbon dioxide tension, oxygen saturation, and pulse rate are…DeviceClass II2Terminated
9 Jul 2012SenTec, V-Sign"2 Sensors The SenTec Digital Monitoring System (SMDS) is used for continuous and noninvasive real-time monitoring of ventilation (tcPCO2) and oxygenation (SpO2).DeviceClass II1Terminated

By type and class

Device9
Class II9

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

12
14
16
18
20
22
24
26
Enforcement events for SenTec AG by year initiated.

Questions and answers

How many FDA recalls has SenTec AG had?

9 enforcement events (14 product records) on this register, 2012–2023: 9 device.

Are any SenTec AG recalls ongoing?

2 events are listed as ongoing in the current openFDA export.

What class are SenTec AG recalls?

9 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.