Class II — ReNovo, Inc.
| Recalling firm | ReNovo, Inc |
|---|---|
| Registered facility | RENOVO, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Non-sterile product was shipped to customers labelled as sterile. |
| 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. |
| Quantity | 81 units |
| Distribution | US Nationwide distribution in the states of CA, NJ and OR. |
| Initiated | 2021-01-19 |
| Classified | 2021-03-02 |
| Recall number | Z-1159-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — ReNovo, Inc. (Z-1159-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/87258/
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