FDA Device recall Z-2539-2017
Cook Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages
- FDA Device
- Class II
- terminated
- Published 2017-06-21
On 2017-06-21 the FDA classified a Class II recall of Cook Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages by Cook, citing correction to the product Instructions for Use because the current reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and ste….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2539-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-05-09 |
| Published | 2017-06-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Cook |
| Distribution | 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 |
Product
Cook Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages
Reason
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.
Identifiers
| code_info | HLF-M273-H30 HLF-M365-H30 HLF-M550-H30 HLF-M940-H30 HLF-M273-HSMA HLF-M365-HSMA HLF-M550-HSMA HLF-M940-HSMA |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2539-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.