SenTec AG FDA Recalls

3 recalls on file across devices, 0 of them Class I and 2 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Membrane Changer Single-Use, REF MC, each package contains 3 changers; Membrane Changer Reloadable, REF MC-R, each packaClass IIJul 25, 2023During rework of components during the manufacturing process	During rework of components during the manufacturing process, an additional piece of material may have been le	Class IIDevices	Jul 25, 2023
V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS).Class IIMay 2, 2023The sensors may experience an out-of-box failure because aft	The sensors may experience an out-of-box failure because after recalibration, the sensors stayed in the softwa	Class IIDevices	May 2, 2023
sentec 24 / MARe-SF Multi-Site Attachment Ring Easy, For sensitive / fragile skin. Used in continuous, noninvasive carbClass IIAug 22, 2022Weak skin adhesion.	Weak skin adhesion.	Class IIDevices	Aug 22, 2022