FDA Device recall Z-1066-2019
BVI Visitec Soft Tip Cannula, 0.8MM .50 x 33mm (25G x 1.3 in)
- FDA Device
- Class II
- terminated
- Published 2019-04-03
On 2019-04-03 the FDA classified a Class II recall of BVI Visitec Soft Tip Cannula, 0.8MM .50 x 33mm (25G x 1.3 in) by Beaver Visitec, citing certain lots are missing a protective sheath component over the silicone tip, which may result in the silicone tip breaking or detaching at the metal tube component. If the tip be….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1066-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-11-30 |
| Published | 2019-04-03 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Beaver Visitec |
| Distribution | US |
Product
BVI Visitec Soft Tip Cannula, 0.8MM .50 x 33mm (25G x 1.3 in). The BVI Soft Tip Cannula is intended to irrigate and/or aspirate ophthalmic solutions and liquids in or out of the eye, and remove materials where appropriate (e.g. retinal, subretinal procedures).
Reason
Certain lots are missing a protective sheath component over the silicone tip, which may result in the silicone tip breaking or detaching at the metal tube component. If the tip becomes detached during a procedure while in the eye, the fragment will need to be retrieved to mitigate the possibility of injury.
Identifiers
| code_info | Lots 60047S4, 60060S9, 600623S |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1066-2019%22
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