DJO, LLC: Medical Device Recall in 2019 - (Recall #: Z-1985-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Aircast REF 3011 - PL RX only VF-PL Sterile Cuff Pkg., Lot# 418003, Expiration Date: 2020 -12 - 31, Made in Mexico, DJO, LLC.

Product Classification:

Class II

Date Initiated: January 17, 2019

Date Posted: July 24, 2019

Recall Number: Z-1985-2019

Event ID: 82967

Reason for Recall:

The product may not meet sterility requirements. Product labeled as sterile, however all units do not appear to meet sterility requirements.

Status: Ongoing

Product Quantity: 9 units

Code Information:

Lot # 418003 UDI: (01)00888912302418

Distribution Pattern:

Distributed domestically, Oklahoma

Voluntary or Mandated:

Voluntary: Firm initiated