Ralston Group Recalls Maximum Pelvic Trainer Due to FDA Registration Errors
Ralston Group is recalling 534 Maximum Pelvic Trainer units because the device was incorrectly listed with the FDA and lacks a required 510(k) submission.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is driven by documentation and registration errors (missing 510(k) and incorrect listing) rather than a physical defect or reported health hazard, fitting the 'documentation issues' criterion for a Low severity score.
Plain-English summary
Ralston Group is voluntarily recalling 534 units of the Maximum Pelvic Trainer (MPT) due to regulatory compliance issues. The device was incorrectly listed with the U.S. Food and Drug Administration (FDA) and the manufacturer did not submit a required 510(k) premarket notification for the device. As a result, the device is considered adulterated and misbranded if left on the market.
The affected units were distributed nationwide to 49 states, the District of Columbia, and Puerto Rico. The recall covers specific lot numbers ranging from 151015008 to 181217005. Consumers who purchased this device should stop using it and contact Ralston Group for instructions on how to return the product or obtain a refund.
The recalled product
- Product
- Maximum Pelvic Trainer (MPT)
- Manufacturer
- Ralston Group
- Category
- Medical Device — Pelvic Health
- Affected units
- 534
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (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
Distribution
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