GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink — Class II medical device recall Z-2029-2012
Terminated recall by Gulf Fiberoptics, Inc., reported 2012-07-25, distributed nationwide. The GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink falls outside of the firm's 510k due to
| Recall number | Z-2029-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Gulf Fiberoptics, Inc., Oldsmar, FL, United States |
| Recall initiated | 2012-04-09 |
| Classified | 2012-07-18 |
| Reported by FDA | 2012-07-25 |
| Terminated | 2013-03-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | ZA |
| Quantity | 169 units |
| Serial numbers | 12195, 12198, 12199, 12200, 12201, 12202, 12203, 12204, 12208, 12209, 12210, 12855, 13023, 13102, 13117, 13258, 13416, 13488, 13489, 13499, 13607, 13609, 13610, 13612, 14059 and 119 more |
Product
GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink. GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink is used to transmit light.
Reason for recall
The GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink falls outside of the firm's 510k due to light transmitting fiber material difference.
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-2029-2012. 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.