Urgent Field Safety Notice For Soltive Single-use Laser Fibers By Gyrus Acmi Inc.

Summary Gyrus ACMI Inc. has issued an urgent safety notice for SOLTIVE Single-use Laser Fibers distributed in Germany and the EU. The notice is classified as Class I, indicating a serious issue with these medical devices. The specific reason for the safety notice is not detailed in the information provided.

Recalling firm
Gyrus ACMI Inc.
Product
SOLTIVE Single-use Laser Fibers
Reason
Urgent Field Safety Notice for SOLTIVE Single-use Laser Fibers by Gyrus ACMI Inc.
Classification
Class I
Category
medical device recall
Country
Germany
Agency
BFARM
Recall date
2026-10-22
Status
Ongoing
Distribution
Germany / EU

Official recall notice from BFARM

Recall details on Nibble Recalls: https://trynibble.app/recalls/d9946570-bbf0-42db-8e95-d55affbc9071