Class II — Synergetics Inc
| Recalling firm | SYNERGETICS, INC. |
|---|---|
| Registered facility | SYNERGETICS, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure. |
| Product | 25ga Awh Chandelier, Synergetics, inc., length 8.0 ft, sterile / EO, 56.50.25P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO. |
| Quantity | 36 units |
| Distribution | Worldwide Distribution-USA (nationwide) and the countries of Argentina, Austria, Brazil, Canada, China, Egypt, France, Germany, Greece, Hong Kong, Italy, Japan, Mexico, Morocco, the Netherlands, Pakistan, South Korea, Spain, Sweden, Switzerland, and the United Kingdom. |
| Initiated | 2013-12-09 |
| Classified | 2014-01-30 |
| Terminated | 2015-03-25 |
| Recall number | Z-0877-2014 |
| 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 — Synergetics Inc (Z-0877-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/67147/
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