Z-2585-2017Class II

OptiLite Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages

Name: Z-2585-2017 OptiLite Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages
Creator: Cook Inc.
Published: 2017-05-03
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2017-05-03 / Terminated / root cause: design

FDA source

Cook Inc. began a recall of OptiLite Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages Product Usage: Used with the Odyssey 30 Holmium Laser... on 2017-05-03. FDA classified it as Class II and gives the reason as "Cook Inc. is initiating a voluntary recall of the OptiLite Multi-Use Holmium Laser Fibers because it has been identified that the reprocessing instructions do not provide sufficiently detailed information for the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2585-2017
Classification: Class II
Status: Terminated
Initiated: 2017-05-03
Posted: 2017-06-14
Terminated: 2019-03-26
Recalling firm: Cook Incorporated
Product: OptiLite Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages Product Usage: Used with the Odyssey 30 Holmium Laser System for fragmentation of urinary calculi and soft tissue applications including incision/excision, ablation, and coagulation
Product code: GEX Powered Laser Surgical Instrument
Reason for recall: Cook Inc. is initiating a voluntary recall of the OptiLite Multi-Use Holmium Laser Fibers because it has been identified that the reprocessing instructions do not provide sufficiently detailed information for the cleaning, disinfection, and sterilization of these products.
Root cause tag: design
FDA root cause: Device Design
Action: Cook is initiating a voluntary recall of multiple products because they have identified the reprocessing instructions do not provide sufficiently detailed information for the cleaning, disinfection, and sterilization of these products. Notices were sent to customers on May 03, 2017 via courier. Customers were asked to do the following: Please contact your local Cook representative for suggested product alternatives to use. FAR2017-030 Page 2 of 2 Action to be taken: 1. Examine your inventory immediately to identify and quarantine those affected products. 2. Return the required Acknowledgement and Receipt Form indicating quantities, part numbers, and lot numbers of affected products within 30 days. 3. Return or discard any affected products. (Instructions regarding product returns are listed in the attached Acknowledgement and Receipt Form.) 4. Even if you do not have affected products, you must still complete the Acknowledgement and Receipt Form and send it via fax (812.339.7316) or email ([email protected]). 5. Immediately report any adverse events to Cook Medical Customer Relations at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30 am and 5:00 pm (Eastern Time), or by email at [email protected]. Adverse events or quality problems experienced with the use of this product may also be reported to the FDA: Online at: http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm (form available to fax or mail) Call the FDA at: 1-800-FDA-1088 This notice must be shared with appropriate personnel, including down to the user level, within your organization or to any organization where the potentially affected devices have been transferred. Should you have any medical questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235.
Quantity in commerce: 10,415
Distribution: Worldwide Distribution - US Nationwide in the states of: AK AL AZ CA CO FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC NJ NY OH OR PA SC SD TN TX WA WI Foreign: Australia, Bolivia, Brazil, Canada, Chile, Columbia, Cyprus, Czech Republic, Germany, Dominican Republic, Greece, Hong Kong, Ireland, Israel, India, Iran, Jordan, Kuwait, Kazakhstan, Lebanon, Sri Lanka, Latvia, Libya, Mexico, Malaysia, New Zealand, Oman, Panama, Peru, Portugal, Serbia, Turkey, Trinidad and Tobago, Taiwan, and Venezuela. VA/DOD: Yes- see below
Product codes and lots: OptiLite Multi-Use Holmium Laser Fibers, Catalog Numbers followed by GPN: HLF-M273-CNV, G48611 HLF-M273-SMA, G48522 HLF-M365-CNV, G48613 HLF-M365-SMA, G48618 HLF-M550-CNV, G48615 HLF-M550-SMA, G48619 HLF-M940-CNV, G48617 HLF-M940-SMA, G48621 HLF-M273-CNV-CAN, G51777 HLF-M273-SMA-CAN, G51785 HLF-M365-CNV-CAN, G51778 HLF-M365-SMA-CAN, G51786 HLF-M550-CNV-CAN, G51779 HLF-M550-SMA-CAN, G51787 HLF-M940-CNV-CAN, G51780 HLF-M940-SMA-CAN, G51788

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2585-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2585-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-14

Product code GEX

K073496Class IIOptilite Holmium Laser FibersCook Urological, Inc. / cleared 2008-01-23

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)