BVI Visitec Soft Tip Cannula — Class II medical device recall Z-1066-2019
Terminated recall by Beaver Visitec, reported 2019-04-03, distributed nationwide. Certain lots are missing a protective sheath component over the silicone tip, which may result in the silicone
| Recall number | Z-1066-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beaver Visitec, Waltham, MA, United States |
| Recall initiated | 2018-11-30 |
| Classified | 2019-03-27 |
| Reported by FDA | 2019-04-03 |
| Terminated | 2020-05-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | MX, PE |
| Quantity | 3,430 units |
| Reason classes | device malfunction |
| Lot numbers | 60047S4, 60060S9, 600623S |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1066-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.