Aircast REF 3011 — Class II medical device recall Z-1985-2019
Ongoing recall by DJO, LLC, reported 2019-07-24, distributed in OK. The product may not meet sterility requirements. Product labeled as sterile, however all units do not appear t
| Recall number | Z-1985-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | DJO, LLC, Vista, CA, United States |
| Recall initiated | 2019-01-17 |
| Classified | 2019-07-18 |
| Reported by FDA | 2019-07-24 |
| Distributed | OK |
| Quantity | 9 units |
| Reason classes | labeling, sterility |
| UPC / GTIN / UDI-DI | 00888912302418 |
| Lot numbers | 2020, 418003 |
| Model numbers | 3011PL |
Product
Aircast REF 3011 - PL RX only VF-PL Sterile Cuff Pkg., Lot# 418003, Expiration Date: 2020 -12 - 31, Made in Mexico, DJO, LLC.
Reason for recall
The product may not meet sterility requirements. Product labeled as sterile, however all units do not appear to meet sterility requirements.
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-1985-2019. 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.