DJO Aircast REF 3011 Sterile Cuff Pkg Recall: Sterility Risk
DJO recalls Aircast REF 3011 sterile cuff packages (Lot #418003) due to potential failure to meet sterility standards. This affects medical use items sold through specific channels.
Lower-risk recall
The product may not meet sterility requirements. Product labeled as sterile, however all units do not appear to meet sterility requirements.
Contact the company
What happened, in plain English
DJO is recalling Aircast REF 3011 sterile cuff packages that may not meet sterility requirements. This means the products could be contaminated and unsafe for medical use. Read more at govinfonow.com/recall/69099-djo-aircast-ref-3011-sterile-cuff-pkg-recall-sterility-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/69099-djo-aircast-ref-3011-sterile-cuff-pkg-recall-sterility-risk · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1985-2019
Cite this page
“DJO Aircast REF 3011 Sterile Cuff Pkg Recall: Sterility Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69099-djo-aircast-ref-3011-sterile-cuff-pkg-recall-sterility-risk. Based on FDA recall #Z-1985-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1985-2019%22&limit=1).
Why it’s dangerous
The products are labeled as sterile but do not consistently meet sterility standards. This could lead to contamination during medical procedures, potentially causing infections.
Who’s affected
Healthcare professionals using these sterile cuff packages for medical procedures. Patients receiving care with these products may be at risk of infection.
How to tell if you have this one
Check for the product name 'Aircast REF 3011 - PL RX only VF-PL Sterile Cuff Pkg.' with Lot #418003 and expiration date December 31, 2020. The items were made in Mexico by DJO, LLC.
- Brand
DJO- Product
Aircast REF 3011 - PL RX only VF-PL Sterile Cuff Pkg., Lot# 418003, Expiration Date: 2020 -12 - 31, Made in Mexico- Category
Medical device
What to do — step by step
Check Product Details
Verify the lot number and expiration date on the packaging to confirm if the item is affected.
Where it went and when
Where it was distributed
Distributed in Oklahoma.
FDA distribution: “Distributed domestically, Oklahoma” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Oklahoma.
Recall timeline
FDA published this recall 6 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1985-2019 (January 17, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1985-2019 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.