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 | Ongoing |
| Reason | The product may not meet sterility requirements. Product labeled as sterile, however all units do not appear to meet sterility requirements. |
| Product | Aircast REF 3011 - PL RX only VF-PL Sterile Cuff Pkg., Lot# 418003, Expiration Date: 2020 -12 - 31, Made in Mexico, DJO, LLC. |
| Quantity | 9 units |
| Distribution | Distributed domestically, Oklahoma |
| Initiated | 2019-01-17 |
| Classified | 2019-07-18 |
| Recall number | Z-1985-2019 |
| 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-1985-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/82967/
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