Various reprocessed products: PROVISION — Class II medical device recall Z-1159-2021
Ongoing recall by ReNovo, Inc., reported 2021-03-10, distributed nationwide. Non-sterile product was shipped to customers labelled as sterile.
| Recall number | Z-1159-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ReNovo, Inc., Bend, OR, United States |
| Recall initiated | 2021-01-19 |
| Classified | 2021-03-02 |
| Reported by FDA | 2021-03-10 |
| Distributed | Nationwide (US) |
| Quantity | 81 units |
| Reason classes | sterility |
| Lot numbers | L-008918-16045, L-008918-16048, L-008926-16037, L-008933-16078, L-008936-16275 |
Product
Various reprocessed products: PROVISION, Reprocessed Smith and Nephew Arthroscopic Shavers, STERILE EO; PROVISION Reprocessed Depy Mitek Ablation Electrodes, VAPR COOLPULSE 90 deg; PROVISION Reprocessed Smith and Nephew Trocars/ Cannulas (Class I); PROVISION Reprocessed Conmed/ Linvatec Suture Retrievers/ Passers C6387 See updated product list attached for details.
Reason for recall
Non-sterile product was shipped to customers labelled as sterile.
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-1159-2021. 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.