FDA Device recall Z-1985-2019
Aircast REF 3011 - PL RX only VF-PL Sterile Cuff Pkg., Lot# 418003, Expiration Date: 2020 -12 - 31, Made in Mexico, DJO, LLC
- FDA Device
- Class II
- ongoing
- Published 2019-07-24
On 2019-07-24 the FDA classified a Class II recall of Aircast REF 3011 - PL RX only VF-PL Sterile Cuff Pkg., Lot# 418003, Expiration Date: 2020 -12 - 31, Made in Mexico, DJO, LLC by Djo, citing the product may not meet sterility requirements. Product labeled as sterile, however all units do not appear to meet sterility requirements.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1985-2019 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-01-17 |
| Published | 2019-07-24 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Djo |
| Distribution | OK |
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
The product may not meet sterility requirements. Product labeled as sterile, however all units do not appear to meet sterility requirements.
Identifiers
| code_info | Lot # 418003 UDI: (01)00888912302418 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1985-2019%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.