Maximum Pelvic Trainer — Class II medical device recall Z-2087-2019
Terminated recall by Ralston Group, reported 2019-08-07, distributed nationwide. The device was incorrectly listed with the FDA and is therefore considered adulterated and misbranded if left
| Recall number | Z-2087-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ralston Group, Selma, AL, United States |
| Recall initiated | 2019-07-12 |
| Classified | 2019-07-26 |
| Reported by FDA | 2019-08-07 |
| Terminated | 2022-04-15 |
| Distributed | Nationwide (US) |
| Quantity | 534 units |
| Reason classes | labeling |
| Lot numbers | 151015008, 160104003, 160411001, 160523009, 160525002, 160921003, 161027002, 161128003, 170111002, 170503002, 170626008, 171120003, 180321003, 180723008, 181217005 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2087-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.