{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 129 } }, "results": [ { "cfres_id": "65466", "product_res_number": "Z-0153-2008", "event_date_initiated": "2007-09-14", "event_date_posted": "2007-12-28", "recall_status": "Terminated", "event_date_terminated": "2009-09-11", "res_event_number": "45435", "product_code": "FYA", "product_description": "Precept Medical Products, Tape Fog Shield Surgical Mask Green Fiberglass Free, REORDER #: 65-3322, non-sterile, 50/box, 5 box/case, Precept Medical Products, Inc., Arden, NC 28704, 1-800-438-5827, Mexico", "code_info": "Lot Numbers: 1053430 through 1061090, and 1060180, 1060190, 1060200, 1060230, 1060240, 1060250, 1060260, 1060270, 1060300, 1060310, 1060320, 1060440, 1060450, 1060460, 1060470, 1060480, 1060510, 1060520, 1060530, 1060660, 1060670, 1060680, 1060970, 1061000, 1061240, 1061250, 1061350, 1061360, 1061370, 1061390, 1061420, 1061440, 1061450, 1061530, 1061560, 1061570, 1061580, 1061590, 1061630, 1061640, 1061650, 1061670, 1061710, 1071720, 1061730, 1061790, 1061800, 1061810, 1061840, 1061850, 1061860, 1061870, 1062010, 1062020, 1062060, 1062070, 1062090, 1062120, 1062130, 1062190, 1062200, 1062210, 1062220, 1062360, 1062370, 1062390, 1062400, 1062440, 1062470, 1062510, 1062540, 1062560, 1062570, 1062580, 1062690, 1062700, 1062710, 1062720, 1062760, 1062770, 1062780, 1062790, 1062820, 1062850, 1062860, 1062890, 1062900, 1062910, 1062970, 1062980, 1063030, 1063040, 1063050, 1063060, 1063180, 1063190, 1063200, 1063260, 1063270, 1063280, 1063290, 1063330, 1063390, 1063400, 1063410, 1063420, 1063430, 1063450, 1063460, 1063470, 1063480, 1063500, 1070080, 1070090, 1070110, 1070120, 1070290, 1070300, 1070310, 1070320, 1070460, 1070470, 1070500, 1070510, 1070520, 1070530, 1070540, 1070600, 1070640, 1070650, 1070660, 1070850, 1070860, 1070870, 1070880, 1071000, 1071310, 1071430, 1071440, 1071450, 1071460, 1071480, 1071490, 1071500, 1071510, 1071520, 1071530, 1071550, 1071620, 1071650, 1071660, 1071670, 1071690, 1071700, 1071710, 1071720, 1071730, 1071740, 1071760, 1071770, 1071780, 1071790, 1071810, 1071830, 1071840, 1071850, 1071860, 1071870, 1071880, 1071900, 1071920, 1071930, 1071940, 1071950, 1071970, 1071980, 1071990, 1072000, 1072050, 1072060, 1072070, 1072080, 1072110, 1072120, 1072130, 1072180, 1072190, 1072200, 1072230, 1072250, 1072260, 1072350, 1072400, 1072410, 1072420, 1072460, 1072470, 1072480, 1072490, 1072500, 1072530, 1072540, 1072550, 1072560, and 1072570,  and Lot Numbers 1062207 through 1071147 (only those lots in this range with the last digit of \"7\" (seven))", "firm_fei_number": "1018223", "recalling_firm": "Precept Medical Products, Inc.", "address_1": "370 Airport Rd", "city": "Arden", "state": "NC", "postal_code": "28704-9202", "additional_info_contact": "Richard Osier\n828-681-0209 Ext. 411", "reason_for_recall": "Small slits under the folds of the masks; thus they may not provide the protection necessary between the patient and surgical staff", "root_cause_description": "Process control", "action": "The firm notified its consignees on 09/14/2007 by Urgent Voluntary Medical Device Recall letter (USPS mail, certified, return-receipt requested). The recall was expanded on 10/04/2007 by Urgent Voluntary Medical Device Recall--Expansion Letter to include additional lots of product. Recall letters instruct users to cease use of devices and return them as well as conduct sub-recalls to the users level for any devices they have sub-distributed.", "product_quantity": "11,546,350 (both products-Z-0153/0154-2008)", "distribution_pattern": "Worldwide; USA, Australia and Canada", "openfda": { "k_number": [ "K212869", "K091097", "K211422", "K172987", "K260725", "K200522", "K230707", "K921889", "K043004", "K080723", "K133075", "K220092", "K092344", "K202447", "K210688", "K102692", "K230577", "K880382", "K922949", "K241214", "K060181", "K021992", "K993148", "K121152", "K984422", "K031408", "K921154", "K042111", "K190950", "K141095", "K911508", "K951623", "K193327", "K211809", "K930681", "K043585", "K023635", "K922753", "K070078", "K994244", "K213703", "K102652", "K992514", "K982058", "K102971", "K221139", "K852870", "K233571", "K811958", "K871906", "K121998", "K864311", "K820116", "K844703", "K090383", "K201351", "K012268", "K902348", "K261028", "K220333", "K950504", 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