Class II — DJO, LLC
| Recalling firm | DJO, LLC |
|---|---|
| Registered facility | View this company's 11 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The device accessories were not labeled with appropriate latex warning. |
| Product | This is an accessory to Intelect Advanced, Intelect Mobile, Intelect Neo, and V-Sonic devices. NYLATEX WRAP - Product Usage: are intended to be used based on the devices associated with them. Nylatex wraps are composed of nylon and natural rubber and are accessories used to secure electrodes or thermal therapy to a patient. |
| Quantity | 41,801 units |
| Distribution | Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI and WV The countries of Algeria, Armenia, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Belgium, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Colombia,… |
| Initiated | 2018-06-25 |
| Classified | 2020-07-13 |
| Terminated | 2022-11-15 |
| Recall number | Z-2590-2020 |
| 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 — DJO, LLC (Z-2590-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/85445/
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