# FDA recall Z-1985-2019

> **DJO, LLC** · Class II · device recall initiated 2019-01-17.

## 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.

## Distribution

Distributed domestically, Oklahoma

## Key facts

- **Recall number:** Z-1985-2019
- **Recalling firm:** DJO, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2019-01-17
- **Report date:** 2019-07-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Vista, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1985-2019

## Citation

> AI Analytics. FDA recall Z-1985-2019. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/Z-1985-2019. Source: US FDA. Licensed CC0.

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