Compass Health Brands (Corporate Office): Medical Device Recall in 2019 - (Recall #: Z-1343-2019)

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:

MediPress pneumatic compression system, Half Leg-Segmental Gradient, Model #6102-S

Product Classification:

Class II

Date Initiated: April 8, 2019

Date Posted: May 22, 2019

Recall Number: Z-1343-2019

Event ID: 82629

Reason for Recall:

Product design change did not receive proper premarket clearance and lacks a 510 (k)

Status: Terminated

Product Quantity:

Code Information:

All Serial Numbers/Lots

Distribution Pattern:

Domestically to AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TN, KY, TX, UT, VA, WA, WI & WY Internationally to Canada

Voluntary or Mandated:

Voluntary: Firm initiated