25 gauge VersaVit 2 — Class II medical device recall Z-0122-2017
Terminated recall by Synergetics Inc, reported 2016-10-26, distributed in AL, CA, IN, KY, MI, MS, NJ, NY…. Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification.
| Recall number | Z-0122-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synergetics Inc, O Fallon, MO, United States |
| Recall initiated | 2016-08-11 |
| Classified | 2016-10-18 |
| Reported by FDA | 2016-10-26 |
| Terminated | 2017-04-27 |
| Distributed | AL, CA, IN, KY, MI, MS, NJ, NY, OH, SC, TN, TX, UT, VA |
| Countries outside the US | FR, GB, IN, MX |
| Quantity | 9 units |
| Lot numbers | M546500 |
| Model numbers | 70935 |
| Expiration dates | 2018-10 |
Product
25 gauge VersaVit 2.0 Vitrectomy Cutter, Product/Part Number 70935, packaged in a Tyvek/Mylar double pouch configuration.
Reason for recall
Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification.
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-0122-2017. 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.