Ralston Group: Medical Device Recall in 2019 - (Recall #: Z-2087-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Maximum Pelvic Trainer (MPT)

Product Classification:

Class II

Date Initiated: July 12, 2019

Date Posted: August 7, 2019

Recall Number: Z-2087-2019

Event ID: 83328

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.

Status: Terminated

Product Quantity: 534 units

Code Information:

Item Code: OBS MPT M.P.T; Lot Numbers: 151015008, 160104003, 160411001, 160523009, 160525002, 160921003, 161027002, 161128003, 170111002, 170503002, 170626008, 171120003, 180321003, 180723008, 181217005

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated