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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83328

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 12, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Ralston Group

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Maximum Pelvic Trainer (MPT)

Z-2087-2019
Recall number
Z-2087-2019
Initiated
July 12, 2019
Classification
Class II
Status
Terminated
Recalling firm
Ralston Group
Quantity
534 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
misbranded

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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 pattern

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.