RecallRadar

FDA Device recall Z-2087-2019

Maximum Pelvic Trainer (MPT)

On 2019-08-07 the FDA classified a Class II recall of Maximum Pelvic Trainer (MPT) by Ralston Group, citing 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 d….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2087-2019
ClassificationClass II
Statusterminated
Initiated2019-07-12
Published2019-08-07
Last updated2026-09-13 11:55 UTC
CompanyRalston Group
DistributionUS

Product

Maximum Pelvic Trainer (MPT)

Reason

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.

Identifiers

code_info
Item Code: OBS MPT M.P.T; Lot Numbers: 151015008, 160104003, 160411001, 160523009, 160525002, 160921003, 161027002, 16…Item Code: OBS MPT M.P.T; Lot Numbers: 151015008, 160104003, 160411001, 160523009, 160525002, 160921003, 161027002, 161128003, 170111002, 170503002, 170626008, 171120003, 180321003, 180723008, 181217005

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2087-2019%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.