Data Foundry

Medical device recalls 2013

Pinook Micro Massager Distributed by www — Class II medical device recall Z-0177-2014

Terminated recall by Pinook-Usa, reported 2013-11-13, distributed nationwide. Failure to submit a premarket submission and gain approval of a medical device.

Recall numberZ-0177-2014
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmPinook-Usa, Orlando, FL, United States
Recall initiated2013-05-23
Classified2013-11-07
Reported by FDA2013-11-13
Terminated2016-09-29
DistributedNationwide (US)
Countries outside the USCA
Quantity28,994 units

Product

Pinook Micro Massager Distributed by www.pinookusa.com Used to strengthen the abdominal muscles.

Reason for recall

Failure to submit a premarket submission and gain approval of a medical 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-0177-2014. 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.