# FDA recall Z-1343-2019

> **Compass Health Brands (Corporate Office)** · Class II · device recall initiated 2019-04-08.

## Product

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

## Reason for recall

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

## 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

## Key facts

- **Recall number:** Z-1343-2019
- **Recalling firm:** Compass Health Brands (Corporate Office)
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-04-08
- **Report date:** 2019-05-22
- **Termination date:** 2020-10-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Middleburg Heights, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1343-2019

## Citation

> AI Analytics. FDA recall Z-1343-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1343-2019. Source: US FDA. Licensed CC0.

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