# FDA recall Z-2087-2019

> **Ralston Group** · Class II · device recall initiated 2019-07-12.

## Product

Maximum Pelvic Trainer (MPT)

## Reason for recall

The device was incorrectly listed with the FDA and is therefore considered adulterated and misbranded if left on the market. Additionally, the firm did not submit a 510k for the device.

## Distribution

Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV and PR.

## Key facts

- **Recall number:** Z-2087-2019
- **Recalling firm:** Ralston Group
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-07-12
- **Report date:** 2019-08-07
- **Termination date:** 2022-04-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Selma, AL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2087-2019

## Citation

> AI Analytics. FDA recall Z-2087-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2087-2019. Source: US FDA. Licensed CC0.

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