FDA Medical Device Recalls (openFDA)
Pinook-Usa: Pinook Mini Massager Distributed by www.pinookusa.com. Used to strengthen the abdominal muscles.
- Recall number
- Z-0176-2014
- Recalling firm
- Pinook-Usa
- Product
- Pinook Mini Massager Distributed by www.pinookusa.com. Used to strengthen the abdominal muscles.
- Status
- Terminated
- Initiated
- 2013-05-23
- Posted
- 2013-11-07
- Terminated
- 2016-09-29
- Reason
- Failure to submit a premarket submission and gain approval of a medical device.
- 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: accounting@pinookusa.com 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
- 28,994 units (Mini and Micro)
- 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.
- Lot, serial or model codes
- ALL LOTS
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NGX
- Firm FEI
- 3008113239
- Firm city
- Orlando
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28