Reported Jul 25, 2012 · Terminated

GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink. GMF-RC65 Replacement Surgical Headlight Cable for…

Gulf Fiberoptics, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Gulf Fiberoptics, Inc. · 448 Commerce Blvd · Oldsmar, FL · 34677-2808

Is this the product you have?

  • GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink. GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink is used to transmit light.
Lot codes and dates
  • Serial Numbers12208,
    • 12209
    • 12204
    • 12855
    • 13023
    • 13102
    • 12203
    • 12210
    • 13117
    • 13258
    • 12202
    • 12201
    • 13416
    • 13489
    12199, 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,
    • 14910
    • 14983
    • 14986
    • 14985
    • 14987
    • 14984
    • 14988
    • 15708
    • 14989
    • 14990
    • 16209
    • 16207
    • 16206
    • 16208
    • 16211
    • 16489
    • 16648
    • 17466
    • 16488
    • 16487
    16793, 16794 16237 17051 17052 17186, 17187,
    • 17188
    • 17014
    • 17288-17289
    • 17476
    • 17467
    • 17464
    • 17321-17324
    • 17860-17861
    • 17899
    • 17898
    • 17506
    • 18452
    • 18451
    • 17903
    • 17901
    • 17889
    • 17891
    • 17890
    • 17888
    • 20854
    • 20860
    • 17902
    • 21095-21096
    20856, 20858, 20859 20420 17900 20387 20855, 20857 20386 20357, 20358 20359 20029, 20030, 20360, 23813, 23814 20385 24462 24597, 24600 24663 25321 25513, 25518 25515 20384 26650, 25514, 25516, 25517 26651, 26652 26653, 26654, 26655 20388 20383 27460 - 27463 20388 20383 27825, 27826 28661, 28664
Amount recalled
169 units

Where it was sold

Why it was recalled

The GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink falls outside of the firm's 510k due to light transmitting fiber material difference.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Mar 7, 2013 · Data as of Sep 19, 6:11 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.