CLASS II ONGOING Device recall · Reported 24 Jul 2019 · FDA Enforcement Report
Aircast REF 3011 - PL RX only Vf-pl Sterile Cuff Pkg recalled by DJO
DJO is recalling Aircast REF 3011 - PL RX only Vf-pl Sterile Cuff Pkg, distributed in Oklahoma. The recall was initiated on 17 Jan 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1985-2019
- FDA event ID
- 82967
- Recalling firm
- DJO, Vista, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 17 Jan 2019
- FDA classified
- 18 Jul 2019
- Reported
- 24 Jul 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 17 Jan 2019 | Recall initiated by company | |
| 18 Jul 2019 | Classified by FDA | +182 days |
| 24 Jul 2019 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The product may not meet sterility requirements. Product labeled as sterile, however all units do not appear to meet sterility requirements.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Aircast REF 3011 - PL RX only VF-PL Sterile Cuff Pkg., Lot# 418003, Expiration Date: 2020 -12 - 31, Made in Mexico, DJO, LLC.
Where it was distributed
Distributed domestically, Oklahoma
Questions about this recall
Why was it recalled?
The product may not meet sterility requirements. Product labeled as sterile, however all units do not appear to meet sterility requirements.
Which lots are affected?
Lot # 418003 UDI: (01)00888912302418
Where was it sold?
Distributed domestically, Oklahoma
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from DJO
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Donjoy Iceman, W/coldpad, Ns, Rh recalled by DJO | DJO | Device Malfunction | Nationwide |
| Device | CLASS II | Donjoy Iceman W/,univ,loop,ns,rh recalled by DJO | DJO | Device Malfunction | Nationwide |
| Device | CLASS II | Donjoy Iceman Classic Cube recalled by DJO | DJO | Device Malfunction | Nationwide |
| Device | CLASS II | Donjoy Iceman W/,univ,loop,ns,eh recalled by DJO | DJO | Device Malfunction | Nationwide |
| Device | CLASS II | Cold Form Wrap: Back recalled by DJO | DJO | Packaging Defects | Nationwide |
Other Other Medical Devices recalls
All 13,908| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Plastics Tray kits recalled by Avid Medical | Avid Medical | Foreign Material | Nationwide |
| Device | CLASS II | Heart Prep Tray kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Pack Open Heart Cfh kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Sperm Ab Elisa (96 well plate test) recalled by DRG International | DRG International | Other | Nationwide |
| Device | CLASS III | BeneView Series recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |