CLASS II ONGOING Device recall · Reported 27 Sep 2023 · FDA Enforcement Report

Membrane Changer Single-Use recalled by SenTec AG

SenTec AG is recalling Membrane Changer Single-Use, distributed nationwide in the US. The recall was initiated on 25 Jul 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesREF MC: 230441, 230224, 230209, 230191, 230185, 230167, 230165, 230146, 230125, 230016, 225261, 225226, 225183, 225173, 225149, 225147, 225126, 225122, 225088, 225073, 225063, 225006; UDI-DI numbers 07640121880933, 17640121880930; REF MC-R: 230461, 230329, 230351, 230235, 230083, 230053, 230043, 230008, 230005, 225253, 225221; UDI-DI numbers 07640121880087, 17640121880084, 27640121880081; REF MC-I: 230372, 230339, 230336, 230229, 230206, 230132, 230117, 230051, 230044, 230012, 225299, 225298, 225280, 225255, 225218, 225216, 225190, 225185, 225184, 225175, 225120, 225091, 225089, 225064, 225058, 225033, 225023, 221064, 221056; UDI-DI numbers 07640121880506, 17640121880503. REVISED 9/21/2023: Additional lot number added for the U.S. for REF MC-I - 225119

Quantity recalledREVISED 9/21/2023-15,065 packages

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2592-2023
FDA event ID: 92833
Recalling firm: SenTec AG, Therwil
Classification: Class II
Status: Ongoing
Recall initiated: 25 Jul 2023
FDA classified: 15 Sep 2023
Reported: 27 Sep 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Patient Monitors

Timeline

25 Jul 2023	Recall initiated by company
15 Sep 2023	Classified by FDA	+52 days
27 Sep 2023	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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).

Where it was distributed

US Nationwide distribution.

Nationwide

Questions about this recall

Is Membrane Changer Single-Use recalled?

Yes. SenTec AG recalled Membrane Changer Single-Use on 25 Jul 2023. The recall is Class II and its status is Ongoing. Recall number Z-2592-2023.

Why was it recalled?

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.

Which lots are affected?

REF MC: 230441, 230224, 230209, 230191, 230185, 230167, 230165, 230146, 230125, 230016, 225261, 225226, 225183, 225173, 225149, 225147, 225126, 225122, 225088, 225073, 225063, 225006; UDI-DI numbers 07640121880933, 17640121880930; REF MC-R: 230461, 230329, 230351, 230235, 230083, 230053, 230043, 230008, 230005, 225253, 225221; UDI-DI numbers 07640121880087, 17640121880084, 27640121880081; REF MC-I: 230372, 230339, 230336, 230229, 230206, 230132, 230117, 230051, 230044, 230012, 225299, 225298, 225280, 225255, 225218, 225216, 225190, 225185, 225184, 225175, 225120, 225091, 225089, 225064, 225058, 225033, 225023, 221064, 221056; UDI-DI numbers 07640121880506, 17640121880503. REVISED 9/21/2023: Additional lot number added for the U.S. for REF MC-I - 225119

Where was it sold?

US Nationwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from SenTec AG

All 14

Reported	Class	Recall	Company	Reason	Where
28 Jun 2023Device	CLASS II	V-Sign Sensor recalled by SenTec AG	SenTec AG	Device Malfunction	Nationwide
9 Nov 2022Device	CLASS II	24 / MARe-SF Multi-Site Attachment Ring Easy recalled by SenTec AG	SenTec AG	Other	Nationwide
24 Feb 2021Device	CLASS II	Digital Monitor recalled by SenTec AG	SenTec AG	Device Malfunction	6 states
14 Aug 2019Device	CLASS II	Membrane Changer Insert [ recalled by SenTec AG	SenTec AG	Device Malfunction	Nationwide
14 Aug 2019Device	CLASS II	Membrane Changer Set (1 charger plus 1 insert) recalled by SenTec AG	SenTec AG	Device Malfunction	Nationwide

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