{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "32317", "product_res_number": "Z-0834-04", "event_date_initiated": "2004-03-29", "event_date_posted": "2004-07-20", "recall_status": "Terminated", "event_date_terminated": "2012-08-02", "res_event_number": "28672", "product_code": "EKB", "product_description": "HENRY SCHEIN(R) 100-8008 Explorer-Double End #5. Barcode *+H658100800808*. Made in China. For professional use only. Instruments must be cleaned and sterilized prior to use. Distributed by: HENRY SCHEIN, INC. 135 Duryea Road, Melville, NY 11747 USA. This product is a dental explorer made of stainless steel packaged individually within a sleeve and containing a cardboard insert (labeling). 510 (k) exempt, Class I device, Device Listing # B057701.", "code_info": "Date Codes/Lot Numbers: 0902, 1202, 0103 (0902 represents September 2002, 1202 represents December 2002, & 0103 represents January 2003); Product Code/Mfr. Part Code 100-8008.", "firm_fei_number": "1416605", "recalling_firm": "Hu-Friedy Mfg Co, Inc.", "address_1": "3232 N Rockwell St", "city": "Chicago", "state": "IL", "postal_code": "60618-5944", "additional_info_contact": "Mr. Michael A. DiBello\n631-843-5847", "reason_for_recall": "Reports of breakage on some dental explorers were received by the own label distributor and forwarded to Hu-Friedy Mfg. Co. (importer of record & Spec. Setter). Investigation conducted by Hu-Friedy Mfg. Co. revealed that the tips of the instruments may have been improperly heat treated and have the potential for unexpected tip fracture.", "root_cause_description": "Other", "action": "On 3/29/04, Hu-Friedy Mfg. Co. notified Henry Schein, Inc. of the recall by telephone. This was followed up with a letter on 4/2/04. Henry Schein initiated a sub-recall to its customers by sending recall letters and response forms (dated 3/31/04) by First Class Mail on 4/2/04 & 4/5/04. The mailing will be followed up with fax, e-mail or phone calls.", "distribution_pattern": "The products were sold to the sole direct account: the Own Label Distributor, Henry Schein, Inc. in Melville, NY. Henry Schein further distributed the explorers to end users nationwide and internationally. Henry Schein Divisions located in Canada, Spain, France, Germany, United Kingdom, Holland, and New Zealand who further distributed the explorers to their customers in Canada and abroad.", "openfda": { "registration_number": [ "", "3015895045", "3003120666", "3036795921", "3035708926", "9613083", "3030671632", "3013547731", "3012421607", "1421879", "3004992978", "9611899", "8010155", "2521453", "3009171220", "2024312", "3013358456", "9612086", "3003882387", "2085199", "3011499367", "8010099", "3002834291", "3009968482", "9680244", "3003418325", "3004168759", "2246990", "3027615", "3044819802", "9614075", "3024946194", "3009340886", "3003407244", "3039435289", "9611503", "8040278", "3010442693", "1419247", "9611367", "3004598675", "2520265", "3027556548", "3008493350", "3030644259", "8041151", "3011371465", "9610612", "3014829979", "3003905396", "3010055973", "3010288346", "3017352116", "3008808049", "1032347", "3043355002", "9680735", "3008770252", "3011625373", "1057946", "9614069", "9681622", "3003969055", "2080222", "3015512299", "9680026", "2954705", "3011600579", "1032227", "3008770655", "8010704", "3001297506", "3008338766", "3029082594", "1419982", "9680515", "3005816808", "1421307", "3009049852", "3013497507", "3009255580", "3014680812", "3005067367", "3004425647", "3019404837", "3006059835", "3005092287", "3005621335", "3005440795", "3005897698", "2431166", "3013946322", "3003759558", "2023950", "9610905", "8040881", "3002769844", "2511556", "1419489", "2916714", "9616119", "3045857207", "3008797953", "8043554", "1413787", "9611283", "3038718579", "3007751820", "3005809810", "3002807115", "8010445", "3003644849", "3003032798", "3003877407", "9611062", "3005831677", "3013552516", "1416605", "3022862651", "3003963832", "3044744766", "3012267976", "3043047788", "3016965929", "1836161", "3009513193", "8010159", "1123010", "3003038445", "3001146947", "3004193466", "8010732", "3023657851", "3021666757", "3014937043", "3006536571", "3012101664", "3008902714", "3013022399", "3014579161", "3004892425", "1422507", "3007064566", "3015176311", "3009703496", "3002769835" ], "fei_number": [ "", "3015895045", "3003120666", "3036795921", "2523865", "3035708926", "3002807754", "3002807464", "3030671632", "3013547731", "3012421607", "3004992978", "2521453", "3009171220", "2024312", "3429", "3002979697", "3013358456", "3005969827", "3003882387", "3011499367", "3002834291", "3006037906", "3009968482", "3003418325", "3004168759", "2246990", "3002750084", "3044819802", "5870", "3002807935", "1000443015", "3024946194", "3009340886", "3003407244", "3039435289", "3010442693", "1419247", "3004598675", "2520265", "3027556548", "3008493350", "3030644259", "3011371465", "3014829979", "3003905396", "3010055973", "3010288346", "1000160732", "1000127001", "3017352116", "3008808049", "3002808335", "1032347", "3002808360", "3043355002", "3008770252", "3011625373", "3007803626", "3008268830", "1000123297", "3003969055", "3546", "3002807169", "2080222", "3015512299", "3011600579", "3001032747", "1000390051", "1032227", "3008770655", "3002806575", "3008338766", "3001297506", "3029082594", "1419982", "3005816808", "1421307", "3009049852", "3013497507", "3009255580", "4476", "3001000014", "3014680812", "1000525271", "3004425647", "3019404837", "3006059835", "1000115048", "3005092287", "3005621335", "3005440795", "4395", "3005897698", "3002291143", "3013946322", "3003759558", "2023950", "3002769844", "2511556", "1419489", "2916714", "3045857207", "3008797953", "3002806816", "1413787", "3002648735", "3038718579", "3007751820", "3005809810", "3002807115", "3003644849", "3003032798", "3003877407", "3005831677", "3022862651", "3013552516", "1416605", "3003963832", "3044744766", "3012267976", "3043047788", "3016965929", "3009513193", "3002806315", "3003038445", "3001146947", "3004193466", "1000508235", "3023657851", "3021666757", "3014937043", "3006536571", "3012101664", "3008902714", "3013022399", "3004095748", "3014579161", "3004892425", "1000159990", "3007064566", "3004216008", "3015176311", "3002807183", "3009703496", "3002769835" ], "k_number": [ "K823914", "K821780", "K851724" ], "device_name": "Explorer, Operative", "medical_specialty_description": "Dental", "regulation_number": "872.4565", "device_class": "1" } } ] }