FDA Device recall Z-1344-2019
MediPress pneumatic compression system Full Leg (Medium)-Segmental Gradient, Model #6103M-S
- FDA Device
- Class II
- terminated
- Published 2019-05-22
On 2019-05-22 the FDA classified a Class II recall of MediPress pneumatic compression system Full Leg (Medium)-Segmental Gradient, Model #6103M-S by Compass Health Brands Corporate Office, citing product design change did not receive proper premarket clearance and lacks a 510 (k).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1344-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-04-08 |
| Published | 2019-05-22 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Compass Health Brands Corporate Office |
| Distribution | 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, TX, UT, VA, WA, WI, WY |
Product
MediPress pneumatic compression system Full Leg (Medium)-Segmental Gradient, Model #6103M-S
Reason
Product design change did not receive proper premarket clearance and lacks a 510 (k)
Identifiers
| code_info | All Serial Numbers/Lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1344-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.