Class II — Cook Inc.
| Recalling firm | COOK, INC. |
|---|---|
| Registered facility | View this company's 5 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| Product | Cook Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages |
| Quantity | 4369 |
| Distribution | Domestic: AL AR AZ CA CO FL GA HI ID IL IN KY LA MD MI MO MS NC NM NY OH OK OR PA SC TN TX UT VA WA WI Foreign: Austria, Australia, Argentina, Azerbaijan, Belgium, Bulgaria, Bahrain, Canada, Chile, China, Cyprus, Czech Republic, Denmark, Djibouti, Egypt, France, Hong Kong, Honduras, Croatia, Greece, Germany, Hungary, India, Ireland, Italy, Latvia, Malaysia, Morocco… |
| Initiated | 2017-05-09 |
| Classified | 2017-06-14 |
| Terminated | 2018-01-26 |
| Recall number | Z-2539-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Cook Inc. (Z-2539-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/77304/
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