Erbe Flexible Cryoprobe
- Recalling firm
- Bio Serve NZ Limited
- Product
- ERBE Flexible cryoprobe. [Device]. Model: ERBE Flexible cryoprobe, single-use. Affected: SKU 20402-402; Lot numbers WO461830 & WO463315
- Reason
- Through complaints, the manufacturer has been made aware of cases with the affected Cryoprobes rupturing/bursting during activation. The rupture causes a loud sound which could cause tinnitus, temporary hearing loss, or persistent hearing loss. In addition, if the probe is held at the rupture/burst location, minor injuries to the hand and/or fingers could occur. The rupture/burst is caused by an insufficient adhesive application in production, leading to excessive input pressure.
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-02-16
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/f431dcd9-1bf6-48b7-9442-0671d737554f