Z-0831-2012

Surgical Headlight labeled in part Gulf Medical FiberopticsOLDSMAR, FLORIDA U.S.A.* Model Numbers...

Name: Z-0831-2012 Surgical Headlight labeled in part *Gulf Medical Fiberoptics*OLDSMAR, FLORIDA U.S.A.* Model Numbers...
Creator: Gulf Medical Fiberoptics, Inc.
Published: 2011-05-13
License: https://open.fda.gov/license/

Gulf Fiberoptics, Inc. / initiated 2011-05-13 / Terminated / root cause: manufacturing process

FDA source

Gulf Medical Fiberoptics, Inc. began a recall of Surgical Headlight labeled in part *Gulf Medical Fiberoptics*OLDSMAR, FLORIDA U.S.A.* Model Numbers: GMF-H001, GMF-H100, GMF-H101, GMF-H102, GMF-H103... on 2011-05-13. The reason FDA records is "Gulf Medical Fiberoptics, Inc. recalled their Surgical Headlight because the cleaning instructions for the exterior surfaces of the headlight , headgear and fiber cable with 70% isopropyl alcohol had not been validated". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0831-2012
Status: Terminated
Initiated: 2011-05-13
Posted: 2012-01-20
Terminated: 2012-08-28
Recalling firm: Gulf Fiberoptics, Inc.
Product: Surgical Headlight labeled in part *Gulf Medical Fiberoptics*OLDSMAR, FLORIDA U.S.A.* Model Numbers: GMF-H001, GMF-H100, GMF-H101, GMF-H102, GMF-H103, GMF-H104, GMF-H105, and GMF-H106. The Surgical Headlight is a passive luminaire. It is illuminated by a source of light by way of the fiber optics and provides supplemental lighting for medical and surgical procedures.
Product code: FST Light, Surgical, Fiberoptic
Reason for recall: Gulf Medical Fiberoptics, Inc. recalled their Surgical Headlight because the cleaning instructions for the exterior surfaces of the headlight , headgear and fiber cable with 70% isopropyl alcohol had not been validated.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On May 16, 2011, Gulf Medical Fiberoptics, Inc. issued to all customers an updated letter to their May 13, 2011 "Field Correction of Instructions For Use" informing them to discontinue the use of 70% isopropyl to clean the surfaces of the device. Enclosed with the letter was an updated Surgical Headlight User Guide with instructions to discard/shred/recycle the prior guide. The firm asked customers to return a form acknowledging the receipt and action from the letter. Customers with questions should contact Customer Service department manager Jacqueline Armand at 813-855-6618 ext. 427.
Quantity in commerce: 381 units
Distribution: Worldwide Distribution - USA, including the states of FL, WI, WA, AL, CA, MO, MI, OH, VA, CO, TX, TN, NC and the countries of Turkey, Brazil, Belgium, South Korea, Panama, Mexico, Ireland, Taiwan (ROC), Italy, Argentina, India, Spain, Germany, and Venezuela.
Product codes and lots: Model Numbers: GMF-H001, GMF-H100, GMF-H101, GMF-H102, GMF-H103, GMF-H104, GMF-H105, GMF-H106.

Product code FST

K061690Class IISurgical HeadlightGulf Medical Fiberoptics / cleared 2006-09-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)