Lower riskMedical device recall · FDA · Published July 25, 2023
SenTec Membrane Changer Recalls: Manufacturing Defect May Affect Measurement
SenTec recalls Membrane Changers (MC, MC-R, MC-I) due to potential manufacturing defect that could impact measurement accuracy. Affected units include specific model numbers and serials.
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.
“SenTec Membrane Changer Recalls: Manufacturing Defect May Affect Measurement.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57613-sentec-membrane-changer-recalls-manufacturing-defect-may-affect-measurement. Based on FDA recall #Z-2592-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2592-2023%22&limit=1).
SenTec AG is recalling Membrane Changer components for the Sentec Digital Monitoring System due to potential manufacturing defects that may impact measurement performance, according to the FDA. The agency announced the Class II recall on July 25, 2023.
During rework of components during the manufacturing process, an additional piece of material may have been left in the device. This defect may result in an impact on measurement performance.
Context
GovInfoNow's records show SenTec AG has issued four other recalls since May 2, 2019. On May 2, 2023, SenTec recalled V-Sign Sensors due to out-of-box failure after recalibration. Other recent recalls of similar products include Medline Convenience Kits Recall: Calibration Issues May Affect Sterility (Jan. 7, 2026) and American Contract Systems Convenience Kit Recall: Catheters May Not Meet Performance Standards (June 29, 2026).
How to tell if you have this one
Check if your Membrane Changer has a model number starting with REF MC, MC-R, or MC-I. The specific model numbers and UDI-DI numbers are listed in the recall notice. All recalled items are components of the Sentec Digital Monitoring System (SDMS).
Brand
SenTec
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Model
Identify if your Membrane Changer has a model number starting with REF MC, MC-R, or MC-I.
Contact Manufacturer
Reach out to SenTec AG to confirm if your device is affected and get guidance on next steps.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Affected model numbers include REF MC (230441, 230224, etc.), REF MC-R (230461, 230329, etc.), and REF MC-I (230372, 230339, etc.) as listed in the recall notice.
Do I need to stop using the product?
No, the recall does not require immediate discontinuation. The hazard is low-risk and only affects measurement accuracy, not physical safety.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2592-2023 (July 25, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2592-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.