Urgent Field Safety Notice For Powerseal By Gyrus Acmi Inc.

POWERSEAL Recall Summary Gyrus ACMI Inc. has issued an urgent field safety notice for POWERSEAL devices distributed in Germany and the EU. The company has classified this as a Class I issue, which indicates a serious problem. No specific details about the defect or affected patient populations are provided in this notice.

Recalling firm: Gyrus ACMI Inc.
Product: POWERSEAL
Reason: Urgent Field Safety Notice for POWERSEAL by Gyrus ACMI Inc.
Classification: Class I
Category: medical device recall
Country: Germany
Agency: BFARM
Recall date: 2026-09-17
Status: Ongoing
Distribution: Germany / EU

Recall details on Nibble Recalls: https://trynibble.app/recalls/00d43462-6741-4d75-8282-c9dbc8d4b59b