Step Bladeless Trocars — Class II medical device recall Z-1387-2023
Ongoing recall by Covidien, LP, reported 2023-04-19, distributed nationwide. Medtronic was made aware of a supplier calibration issue during the contract sterilization process that may le
| Recall number | Z-1387-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien, LP, North Haven, CT, United States |
| Recall initiated | 2023-03-01 |
| Classified | 2023-04-12 |
| Reported by FDA | 2023-04-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CO, ID, NP, SV, TH, TW |
| Quantity | 770 units |
| UPC / GTIN / UDI-DI | 10884521090767 |
| Lot numbers | P2G0069 |
Product
Step Bladeless Trocars, 10 mm cannula and dilator with radially expandable sleeve and 5 - 10 mm reducer, Product Number S101010
Reason for recall
Medtronic was made aware of a supplier calibration issue during the contract sterilization process that may lead to unsterile product. Use of affected product may lead to an unspecified infection or, in the case of sutures used in the eye, pose a loss of vision risk.
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-1387-2023. 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.