MediPress pneumatic compression system Full Arm — Class II medical device recall Z-1348-2019
Terminated recall by Compass Health Brands (Corporate Office), reported 2019-05-22, distributed in AL, AR, AZ, CA, CO, FL, GA, IA…. Product design change did not receive proper premarket clearance and lacks a 510 (k)
| Recall number | Z-1348-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Compass Health Brands (Corporate Office), Middleburg Heights, OH, United States |
| Recall initiated | 2019-04-08 |
| Classified | 2019-05-15 |
| Reported by FDA | 2019-05-22 |
| Terminated | 2020-10-26 |
| Distributed | 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 |
| Countries outside the US | CA |
| Model numbers | 6104S-S |
Product
MediPress pneumatic compression system Full Arm (Short)-Segmental Gradient, Model #6104S-S
Reason for recall
Product design change did not receive proper premarket clearance and lacks a 510 (k)
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1348-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.