FDA Device recall Z-2087-2019
Maximum Pelvic Trainer (MPT)
- FDA Device
- Class II
- terminated
- Published 2019-08-07
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
| Agency | FDA Device |
|---|---|
| Recall number | Z-2087-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-07-12 |
| Published | 2019-08-07 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ralston Group |
| Distribution | US |
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
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