23ga Wide Field Corona Endo Illuminator — Class II medical device recall Z-0889-2014
Terminated recall by Synergetics Inc, reported 2014-02-05, distributed nationwide. Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could resu
| Recall number | Z-0889-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synergetics Inc, O Fallon, MO, United States |
| Recall initiated | 2013-12-09 |
| Classified | 2014-01-30 |
| Reported by FDA | 2014-02-05 |
| Terminated | 2015-03-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, BR, CA, CH, CN, DE, EG, ES, FR, GB, GR, HK, IT, JP, KR, MA, MX, NL, PK, SE |
| Quantity | 108 units |
| Reason classes | sterility, packaging |
| Lot numbers | M264050, M269440, M277900 |
Product
23ga Wide Field Corona Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.12.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
Reason for recall
Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
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-0889-2014. 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.