Z-2087-2019Class II

Maximum Pelvic Trainer (MPT)

Name: Z-2087-2019 Maximum Pelvic Trainer (MPT)
Creator: Ralston Group
Published: 2019-07-12
License: https://open.fda.gov/license/

Ralston Group / initiated 2019-07-12 / Terminated / root cause: labeling and UDI

FDA source

Ralston Group began a recall of Maximum Pelvic Trainer (MPT) on 2019-07-12. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2087-2019
Classification: Class II
Status: Terminated
Initiated: 2019-07-12
Posted: 2019-07-26
Terminated: 2022-04-15
Recalling firm: Ralston Group
Product: Maximum Pelvic Trainer (MPT)
Product code: HIR Perineometer
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.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Ralston Group notified customers on about 07/12/2019 via "IMPORTANT VOLUNTARY: MEDICAL DEVICE RECALL" email. Customers were advised that the device was incorrectly registered with the FDA and is therefore considered adulterated and misbranded if left on the market. Processes and documentation regarding the manufacture of this device were not adequately maintained. Also, clinical trials and claims concerning the effectiveness of the MPT were not evaluated by the FDA. Instructions included to immediately examine inventory for affected product, discontinue use/distribution, and quarantine al affected product. Customers were requested to complete the provided MEDICAL DEVICE RECALL RETURN RESPONSE to confirm receipt and understanding, and arrange for return of all affected product by contacting customer service at [email protected] or call 1-800-867-3726, Monday -Friday 8 AM 5 PM Central Time. Also customers were instructed to notify customers if the product was further distributed.
Quantity in commerce: 534 units
Distribution: 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.
Product codes and lots: Item Code: OBS MPT M.P.T; Lot Numbers: 151015008, 160104003, 160411001, 160523009, 160525002, 160921003, 161027002, 161128003, 170111002, 170503002, 170626008, 171120003, 180321003, 180723008, 181217005

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2087-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2087-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-07	2019-07-26

Product code HIR

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)