Urgent Field Safety Notice For Iris By Comecer Netherlands B.v.

Recall Summary COMECER Netherlands B.V. has issued a Class I urgent field safety notice for IRIS devices distributed in Germany and the EU. The specific product details and reason for the recall are not clearly stated in the provided document excerpt. This is a medical device recall affecting users in Germany and EU countries.

Recalling firm
Urgent Field Safety Notice for IRIS by COMECER Netherlands B.V. , Download_VeroeffentlichtAm_EN 2026.06.09 PDF, 318KB, F
Product
s Tasks of the BfArM Risk assessment Field corrective actions Urgent Field Safety Notice for IRIS by COMECER Netherlands B
Reason
assessment Field corrective actions Urgent Field Safety Notice for IRIS by COMECER Netherlands B
Classification
Class I
Category
medical device recall
Country
Germany
Agency
BFARM
Recall date
2026-06-09
Status
Ongoing
Distribution
Germany / EU

Official recall notice from BFARM

Recall details on Nibble Recalls: https://trynibble.app/recalls/2e4486f9-1dfb-422f-82ab-39ce4ef8f3a1