Ebus Needle 19g
- Recalling firm
- Olympus (NZ) Ltd
- Product
- EBUS Needle 19G. [Device]. Model: NA-U403SX-4019 VIZISHOT 2 FLEX EBUS-TBNA NEEDLE. Affected: All lots
- Reason
- The manufacturer received complaints for the ViziShot 2 FLEX (19G) devices in which the hypotube component ejected from the device or plastic components detached during use. Since the previous Recall notice in August 2025, internal investigations have identified additional contributing factors to hypotube component ejection including device heat-shrink material degradation and use errors.
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-01-15
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/d390ae06-ea5f-4c2a-847b-43baac916776