Maximum Pelvic Trainer recalled over labeling errors

Recall date

July 12, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Ralston Group recalls Maximum Pelvic Trainer (MPT)

Recall number

Z-2087-2019

FDA classification

Class II

Brand / firm

Ralston Group

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Maximum Pelvic Trainer (MPT)