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Recall

Class II — SenTec AG

Recalling firmSentec, Inc.
Registered facilitySENTEC, INC. (the firm's only registered facility)
ClassificationClass II
StatusTerminated
ReasonWeak skin adhesion.
Productsentec 24 / MARe-SF Multi-Site Attachment Ring Easy, For sensitive / fragile skin. Used in continuous, noninvasive carbon dioxide and/or oxygen tension monitoring.
Quantity17208 units
DistributionUS Nationwide distribution.
Initiated2022-08-22
Classified2022-10-28
Terminated2026-05-26
Recall numberZ-0148-2023
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — SenTec AG (Z-0148-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90938/

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