Urgent Field Safety Notice For Opn Nc By Sis Medical Ag
Summary SIS Medical AG has issued an urgent recall for the OPN NC device due to a safety concern that poses a serious risk. The device was distributed in Germany and the EU. This is a Class I recall, indicating the most serious type of safety issue.
- Recalling firm
- SIS Medical AG
- Product
- OPN NC
- Reason
- Urgent Field Safety Notice for OPN NC by SIS Medical AG
- Classification
- Class I
- Category
- medical device recall
- Country
- Germany
- Agency
- BFARM
- Recall date
- 2026-07-01
- Status
- Ongoing
- Distribution
- Germany / EU
Official recall notice from BFARM
Recall details on Nibble Recalls: https://trynibble.app/recalls/fd073e8f-fa0f-4354-b74d-ffdf4f90eb5a