Maximum Pelvic Trainer recall
Maximum Pelvic Trainer (MPT)
Why was Maximum Pelvic Trainer recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Item Code: OBS MPT M.P.T; Lot Numbers: 151015008, 160104003, 160411001, 160523009, 160525002, 160921003, 161027002, 161128003, 170111002, 170503002, 170626008, 171120003, 180321003, 180723008, 181217005
- Product
- Maximum Pelvic Trainer (MPT)
- Recalling firm
- Ralston Group
- Quantity
- 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.
- Recall date
- August 7, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)