VersaOne Reusable Positioning Cannula 11mm Standard — Class II medical device recall Z-1464-2023
Ongoing recall by Covidien LP, reported 2023-05-03, distributed nationwide. There is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside of the VersaO
| Recall number | Z-1464-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien LP, Mansfield, MA, United States |
| Recall initiated | 2023-03-22 |
| Classified | 2023-04-26 |
| Reported by FDA | 2023-05-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, DE, DK, ES, FR, IN, IT, NL, SE |
| Quantity | 51 units |
| Reason classes | foreign material |
| UPC / GTIN / UDI-DI | 10884521784048 |
| Serial numbers | C20RSJ0002, C20RSJ0003, C20RSJ0004, C20RSL0062, C20RSL0063, C20RSL0066, C20RSL0070, C20RSL0071, C20RSL0072, C20RSL0073, C20RSL0074, C20RSL0075, C20RSL0076, C20RSL0077, C20RSL0078, C20RSL0080, C20RSL0083, C20RSL0085, C20RSL0086, C20RSL0087, C20RSL0088, C20RSL0095, C20RSL0097, C20RSL0098, C21RSJ0001 and 26 more |
| Model numbers | RC11STS |
Product
VersaOne Reusable Positioning Cannula 11mm Standard, Model Number RC11STS
Reason for recall
There is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside of the VersaOneTM Reusable Positioning Cannula, located where the Cannula and Body components are welded together.
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-1464-2023. 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.