Class II — Gulf Fiberoptics, Inc.
| Recalling firm | GULF FIBEROPTICS, INC |
|---|---|
| Registered facility | GULF FIBEROPTICS, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink falls outside of the firm's 510k due to light transmitting fiber material difference. |
| Product | GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink. GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink is used to transmit light. |
| Quantity | 169 units |
| Distribution | Worldwide distribution: USA (nationwide) including states of: AL, CA, CO, FL, MI, NC, NJ, NY, OH, PA, TN, TX and WI and country of: South Africa. |
| Initiated | 2012-04-09 |
| Classified | 2012-07-18 |
| Terminated | 2013-03-07 |
| Recall number | Z-2029-2012 |
| 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 — Gulf Fiberoptics, Inc. (Z-2029-2012).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/62408/
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