Z-0177-2014Class II

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

Name: Z-0177-2014 Pinook Micro Massager Distributed by www.pinookusa.com Used to strengthen the abdominal muscles
Creator: Pinook-Usa
Published: 2013-05-23
License: https://open.fda.gov/license/

Pinook USA / initiated 2013-05-23 / Terminated

FDA source

Pinook-Usa began a recall of Pinook Micro Massager Distributed by www.pinookusa.com Used to strengthen the abdominal muscles on 2013-05-23. FDA classified it as Class II and gives the reason as "Failure to submit a premarket submission and gain approval of a medical device". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0177-2014
Classification: Class II
Status: Terminated
Initiated: 2013-05-23
Posted: 2013-11-07
Terminated: 2016-09-29
Recalling firm: Pinook USA
Product: Pinook Micro Massager Distributed by www.pinookusa.com Used to strengthen the abdominal muscles.
Product code: NGX Stimulator, Muscle, Powered, For Muscle Conditioning
Reason for recall: Failure to submit a premarket submission and gain approval of a medical device.
FDA root cause: No Marketing Application
Action: On October 18, 2013 the firm sent the following notification to their customers: This is to inform you of a product recall involving: Pinooks Mini-massager and Pinooks Micro Massager model number PT-11 See enclosed product label (for ease in identifying the product at retail/user level). This recall has been initiated due to failure to submit a premarket submission and gain approval. We began shipping this product on 11/27/2012. Immediately examine your inventory and quarantine product subject to recall. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. Pinook USA is removing the products (mini and micro massager) from the market until receiving FDA approval to market them again under a new 510(k). If you have stock on your end please return them to our office: 901 C FL PKWY STE A6, Orlando FL, 32824. Before returning, please contact Sheva Ben-Shushan: [email protected] in order to receive an RMA number. Once you have RMA number, place that number on the package label. This recall should be carried out to the retail level. Your assistance is appreciated and necessary to prevent patient harm. If you have any questions, call Dvir Lev-Ran, telephone number: 407-854-0055 Ext 304. This recall is being made with the knowledge of the Food and Drug Administration.
Quantity in commerce: 28,994 units (Micro and Mini)
Distribution: Worldwide Distribution-USA (nationwide) including Puerto Rico and Guam and the states of AZ, CA, CO, FL, IL, MA, MD, MO, MT, NC, ND, NJ, NV, NY, TX, VA, and WA and the country of Canada.
Product codes and lots: ALL LOTS

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0177-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0176-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-13	2013-11-07
Z-0177-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-13	2013-11-07

Product code NGX

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)