# FDA recall Z-2585-2017

> **Cook Inc.** · Class II · device recall initiated 2017-05-03.

## 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

## 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.

## 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

## Key facts

- **Recall number:** Z-2585-2017
- **Recalling firm:** Cook Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-05-03
- **Report date:** 2017-06-21
- **Termination date:** 2019-03-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bloomington, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2585-2017

## Citation

> AI Analytics. FDA recall Z-2585-2017. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2585-2017. Source: US FDA. Licensed CC0.

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