Urgent Field Safety Notice For Hydragel 7 Iso-pal ; Hydragel 15 Iso-pal By Sebia

SEBIA is issuing an urgent safety notice for HYDRAGEL 7 ISO-PAL and HYDRAGEL 15 ISO-PAL products distributed in Germany and the EU. These are laboratory diagnostic devices used for testing. The notice indicates a Class I safety issue, which is the most serious classification level, though the specific problem is not detailed in this notice.

Recalling firm

SEBIA

Product

HYDRAGEL 7 ISO-PAL ; HYDRAGEL 15 ISO-PAL

Reason

Urgent Field Safety Notice for HYDRAGEL 7 ISO-PAL ; HYDRAGEL 15 ISO-PAL by SEBIA

Classification

Class I

Category

medical device recall

Country

Germany

Agency

BFARM

Recall date

2026-10-29

Status

Ongoing

Distribution

Germany / EU

Official recall notice from BFARM

Recall details on Nibble Recalls: https://trynibble.app/recalls/be53cffc-a8f3-49a3-bbc4-63d2aa9fb2d9