{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "155751", "product_res_number": "Z-2587-2017", "event_date_initiated": "2017-05-11", "event_date_created": "2017-06-14", "recall_status": "Open, Classified", "res_event_number": "77330", "product_code": "BSR", "product_description": "Sheridan SHER-I-SLIP and SOFT-TIP Intubating Stylets are intubating stylets manufactured from galvanized carbon steel and aluminum rods that are coated with a blue PVC or polypropylene outer covering and are designed to be placed inside an endotracheal tube to obtain a desired shape during intubation.", "code_info": "Product Code 5-15103 - Lot Number 73J1600218, 73K1600376, 73K1600587, 73L1600158, 73M1600275, 73A1700733;", "firm_fei_number": "3005747797", "recalling_firm": "Teleflex Medical", "address_1": "2917 Weck Dr", "city": "Research Triangle Park", "state": "NC", "postal_code": "27709-0186", "additional_info_contact": "Elizabeth Norwood\n919-544-8000", "reason_for_recall": "Product size listed on the labeling is incorrect.", "root_cause_description": "Labeling mix-ups", "action": "Recall letters were sent to consignees on 5/11/2017 asking them to check inventory and immediately discontinue use of the product. The letter included a reply form to be returned. A separate letter was sent to distributors requesting that they conduct a sub-recall.", "product_quantity": "21,690 eaches", "distribution_pattern": "Worldwide Distribution - US Nationwide in the states of CT, FL, ID, IN, KY, MA, MI, MN, MO, NE, NJ, NY, NC, OH, PA, RI, SD, TX, UT, WA and countries of Canada, Czech Republic, Denmark, Germany, Israel, & Portugal", "openfda": { "device_name": "Stylet, Tracheal Tube", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5790", "device_class": "1", "k_number": [ "K935797", "K954771", "K950380", "K950713", "K865108", "K162729", "K940799", "K944729", "K943104", "K770374", "K912690", "K905133", "K932081", "K933598", "K910659", "K832773", "K955238", "K920468", "K921128", "K772046", "K914965", "K902180", "K962361", "K843490", "K802416", "K844557", "K905052", "K904999", "K952266", "K922842", "K953677", "K952100" ], "registration_number": [ "8021995", "3015966505", "2936999", "3008806809", "3002675176", "3013557562", "2032273", "3033010858", "9613073", "1820334", "3010149039", "3001313714", "3012970776", "3012494290", "3007127332", "3007829657", "2020550", "3015216264", "3004748541", "3012991986", "3006210673", "1061927", "1721686", "3022518300", "3011050534", "8030673", "3018366470", "3011237770", "3016634868", "1058584", "3011252788", "3010202439", "3045058049", "3015152450", "3011137372", "3003213883", "3009746061", "3044186618", "9612501", "3008808049", "3010400865", "3012287892", "3013503739", "3024026674", "9680143", "2183650", "3015142721", "3013528571", "3042248499", "2183744", "8020889", "3003674698", "3042022216", "1720929", "3004527595", "2025816", "3003477135", "1825146", "3003965134", "3009771213", "2183828", "9617604", "9615393", "3014579161", "3008676146", "3010396739", "3002807267", "9680721", "3011600579", "3003898360", "3018762668", "8040278", "3022472", "3016734145", "3010594263", "3010834934", "3007728072", "1047843", "3010131137", "3006389770", "8040510", "3006061749", "3020984207", "3011987967", "8020785", "9681384", "3005273623", "9680222", "3013055504", "3013412170", "1423662", "3009039068", "3030733800", "3006787036", "3005609751", "3004056932", "3018074706", "3007421149", "1314417", "8010939", "3000279801", "3006973666", "3010220595", "3006542380", "9614084", "3006157842", "3011497859", "1836161", "3010041511", "3013576541", "8022032", "3017166758", "1928237", "2022648", "3003528228", "8040412", "3006897996", "1048735", "3021244152", "9616567", "8044169", "3018094310", "3013188547", "3014208300", "3043226252", "3004992992", "3004111573", "3021010418", "3018503755", "1045254", "3005327291", "3010402691", "3000247987", "3006446479", "3014544429" ], "fei_number": [ "3003927064", "3015966505", "2936999", "3008806809", "3002675176", "3013557562", "3033010858", "3002750084", "3002808440", "1820334", "3010149039", "3002807293", "3012970776", "3009291251", "3012494290", "3002963732", "3007127332", "3007829657", "2020550", "3015216264", "3004748541", "3012991986", "3006210673", "3007475226", "3001620388", "3022518300", "1721686", "3011050534", "3002558692", "3018366470", "3011237770", "3016634868", "3011252788", "3045058049", "3015152450", "3003213883", "3009746061", "3044186618", "3008808049", "3003495548", "3003154916", "3010400865", "3012287892", "3013503739", "3024026674", "2183650", "3015142721", "3013528571", "3042248499", "3001717360", "2183744", "1000283452", "3003674698", "3042022216", "1720929", "3004527595", "2025816", "3000203000", "3003477135", "1825146", "3003965134", "3009771213", "2183828", "3014579161", "3008676146", "3010396739", "3002807267", "3011600579", "3003898360", "3018762668", "3022472", "3016734145", "3010594263", "3001319476", "3010834934", "3007728072", "1047843", "3010131137", "3005747797", "3006389770", "3006061749", "3020984207", "3011987967", "1000219637", "3005273623", "3013055504", "3002807626", "3013412170", "3006363476", "1000244733", "3009039068", "3003382061", "3030733800", "3006787036", "3005609751", "3004056932", "3018074706", "3007421149", "1314417", "3000279801", "3006973666", "3010220595", "3006542380", "3006157842", "3011497859", "3010041511", "3013576541", "3017166758", "3002807308", "1928237", "2022648", "3003528228", "3003240904", "3006897996", "1048735", "3021244152", "3018094310", "3013188547", "3000215273", "3014208300", "3043226252", "3004992992", "3004111573", "3004216008", "3021010418", "3005947796", "3018503755", "3009271244", "3005327291", "1045254", "3010402691", "3000247987", "3006446479", "3004213967", "3014544429" ] } } ] }