{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "122609", "product_res_number": "Z-0176-2014", "event_date_initiated": "2013-05-23", "event_date_posted": "2013-11-07", "recall_status": "Terminated", "event_date_terminated": "2016-09-29", "res_event_number": "66191", "product_code": "NGX", "product_description": "Pinook Mini Massager \r\nDistributed by www.pinookusa.com.\r\n\r\nUsed to strengthen the abdominal muscles.", "code_info": "ALL LOTS", "firm_fei_number": "3008113239", "recalling_firm": "Pinook-Usa", "address_1": "901 Central Florida Pkwy Ste A6 901 Central Florida Pkwy", "address_2": "Ste A6", "city": "Orlando", "state": "FL", "postal_code": "32824-8508", "additional_info_contact": "Sheva Ben-Shushan\n407-854-0055 Ext. 301", "reason_for_recall": "Failure to submit a premarket submission and gain approval of a medical device.", "root_cause_description": "No Marketing Application", "action": "On October 18, 2013 the firm sent the following notification to their customers:\r\n\r\nThis is to inform you of a product recall involving: \r\n\r\nPinooks Mini-massager and Pinooks Micro Massager model number PT-11 \r\nSee enclosed product label (for ease in identifying the product at retail/user level). \r\n\r\nThis recall has been initiated due to failure to submit a premarket submission and gain approval.\r\n\r\nWe began shipping this product on 11/27/2012. \r\nImmediately 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.\r\n\r\nPinook 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).\r\n\r\nIf you have stock on your end please return them to our office:\r\n901 C FL PKWY STE A6, Orlando FL, 32824.\r\nBefore returning, please contact Sheva Ben-Shushan: accounting@pinookusa.com in order to receive an RMA number.\r\nOnce you have RMA number, place that number on the package label.\r\n\r\nThis recall should be carried out to the retail level. \r\nYour assistance is appreciated and necessary to prevent patient harm.\r\n \r\nIf you have any questions, call Dvir Lev-Ran, telephone number: 407-854-0055 Ext 304. \r\n\r\nThis recall is being made with the knowledge of the Food and Drug Administration.", "product_quantity": "28,994 units (Mini and Micro)", "distribution_pattern": "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.", "openfda": { "k_number": [ "K081026", "K130074", "K182020", "K061632", "K093368", "K223797", "K011880", "K182519", "K122414", "K102926", "K232982", "K172876", "K201257", "K202148", "K253636", "K190038", "K183454", "K253408", "K133225", "K152420", "K170903", "K183103", "K121719", "K062439", "K251378", "K250759", "K201845", "K071666", "K100320", "K181955", "K181728", "K122393", "K180688", "K231318", "K221200", "K231789", "K143059", "K170918", "K020427", "K212866", "K110057", "K251594", "K211942", "K250038", "K161974", "K182794", "K070142", "K163165", "K241685", "K134001", "K233492", "K083140", "K213748", "K083164", "K143551", "K141921", "K242926", "K143207", "K132179", "K111781", "K190966", "K203513", "K111476", "K220938", "K232409", "K130723", "K232181", "K220601", "K200382", "K250146", "K212948", "K022855", "K133108", 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