Stryker Sustainability Solutions: Medical Device Recall in 2016 - (Recall #: Z-0629-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Reprocessed Stryker Color Cuff and Color Cuff II Adult Tourniquet Cuffs Model Numbers: 5921-218-135, 5921-044-135, 5921-034-135, 5921-034-235, 5921-024-236 Indicated for use in patients who require surgery of the extremities.

Product Classification:

Class II

Date Initiated: December 17, 2015

Date Posted: January 20, 2016

Recall Number: Z-0629-2016

Event ID: 72880

Reason for Recall:

Reprocessed Stryker Pressure Tourniquet Cuffs were mislabeled, including some labeled as single port when they contained dual port, and vice versa.

Status: Terminated

Product Quantity: 450 devices

Code Information:

Model #5921-218-135 Lot #3490521 Model #5921-034-235 Lot #3531111 Model #5921-034-135 Lot #3733336, 4002152 Model #5921-044-135 Lot #3759409 Model #5921-024-236 Lot #3822485

Distribution Pattern:

Nationwide Distribution including the states of AK, NV, VT, FL, CA, CO, WI, IA, MN, OK, PA, MI, OR, KY, and MA.

Voluntary or Mandated:

Voluntary: Firm initiated