Gulf Fiberoptics Recalls GMF-RC65 Surgical Headlight Cables
Gulf Fiberoptics, Inc. is recalling 169 GMF-RC65 Replacement Surgical Headlight Cables because the light-transmitting fiber material differs from the approved 510(k) design.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any injuries or illnesses. The hazard is a regulatory compliance issue regarding material differences rather than a reported safety incident, fitting the criteria for a moderate severity score.
Plain-English summary
Gulf Fiberoptics, Inc. is recalling 169 units of the GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink. These cables are used to transmit light in surgical settings.
The recall was initiated because the product falls outside of the firm's 510(k) clearance due to a difference in the light-transmitting fiber material. The source text does not report any specific injuries, illnesses, or adverse events associated with the use of these cables.
The affected units were distributed worldwide, including nationwide in the United States (specifically in AL, CA, CO, FL, MI, NC, NJ, NY, OH, PA, TN, TX, and WI) and in South Africa. Users should check their serial numbers against the list provided by the FDA and contact Gulf Fiberoptics, Inc. for instructions on how to return or replace the product.
The recalled product
- Product
- GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink. GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink is used to transmit light.
- Manufacturer
- Gulf Fiberoptics, Inc.
- Affected units
- 169
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Serial Numbers: 12208
- 13488 12198 12200 13499 12195
- 13612 13607 14186 13610 13609 14184 14059
- 14060 14164
- 14165 14185 14190 14330 14333 14395
- 14396
- 14397 14485 14509 14508 14559 14580 14670
- 14671
- 14672 14680
- 14681 14690 - 14699 14909
- 16794 16237 17051 17052 17186
- 17187
- 20858
- 20859 20420 17900 20387 20855
- 20857 20386 20357
- 20358 20359 20029
- 20030
- 20360
- 23813
- 23814 20385 24462 24597
Distribution
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