Class II — Compass Health Brands (Corporate Office)
| Recalling firm | Compass Health Brands (Corporate Office) |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Product design change did not receive proper premarket clearance and lacks a 510 (k) |
| Product | MediPress pneumatic compression system Full Arm (Medium)-Segmental Gradient, Model #6104M-S |
| Distribution | 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 |
| Initiated | 2019-04-08 |
| Classified | 2019-05-15 |
| Terminated | 2020-10-26 |
| Recall number | Z-1345-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Compass Health Brands (Corporate Office) (Z-1345-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/82629/
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