Urgent Field Safety Notice For Reflexx N 100 By Reflexx S.p.a.

Reflexx N 100 Recall Summary Reflexx S.P.A. has issued an urgent field safety notice for the Reflexx N 100 device, classified as a Class I recall. The notice affects devices distributed in Germany and the EU, though the specific reason for the recall is not clearly stated in the available notice text. This is a medical device recall requiring immediate attention from affected users or healthcare facilities.

Recalling firm
Urgent Field Safety Notice for Reflexx N 100 by Reflexx S.P.A. , Download_VeroeffentlichtAm_EN 2026.05.05 PDF, 420KB, Fi
Product
s Tasks of the BfArM Risk assessment Field corrective actions Urgent Field Safety Notice for Reflexx N 100 by Reflexx S
Reason
assessment Field corrective actions Urgent Field Safety Notice for Reflexx N 100 by Reflexx S
Classification
Class I
Category
medical device recall
Country
Germany
Agency
BFARM
Recall date
2026-05-05
Status
Ongoing
Distribution
Germany / EU

Official recall notice from BFARM

Recall details on Nibble Recalls: https://trynibble.app/recalls/4458150a-9c07-4b45-8cd5-b86b2e09488d