Cook Multi-Use Holmium Laser Fibers — Class II medical device recall Z-2539-2017
Terminated recall by Cook Inc., reported 2017-06-21, distributed in AL, AR, AZ, CA, CO, FL, GA, HI…. Correction to the product Instructions for Use because the current reprocessing instructions do not provide su
| Recall number | Z-2539-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cook Inc., Bloomington, IN, United States |
| Recall initiated | 2017-05-09 |
| Classified | 2017-06-14 |
| Reported by FDA | 2017-06-21 |
| Terminated | 2018-01-26 |
| Distributed | AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KY, LA, MD, MI, MO, MS, NC, NM, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, WA, WI |
| Countries outside the US | AR, AT, AU, BE, BG, BH, CA, CL, CN, CY, CZ, DE, DK, EG, ES, FR, GB, GR, HK, HN, HR, HU, IE, IN, IT, LK, LV, MA, MY, NL, PL, PT, RS, SA, SE, SG, SI, TH, TN, TW, UY, ZA |
| Quantity | 4,369 |
Product
Cook Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages
Reason for recall
Correction to the product Instructions for Use because the current reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2539-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.