{ "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": "2026-09-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "199110", "product_res_number": "Z-1474-2023", "event_date_initiated": "2023-03-02", "event_date_posted": "2023-04-28", "recall_status": "Open, Classified", "res_event_number": "91891", "product_code": "FCW", "k_numbers": [ "K082813" ], "product_description": "SafeLight Fiber Optic Cable: Clear, 5MM X 10FT 3.05M, REF: 0233-050-100; Gray, 5MM X 10FT 3.05M, REF: 0233-050-200", "code_info": "Ref/UDI-DI/Lot:\n0233-050-100/07613327051650/159190, 159191, 159192, 159194, 159195, 159196, 159197, 159198, 159199, 159200, 159201, 159202, 159203, 159204, 159205, 159206, 159207, 159208, 159209, 159210, 159211, 159212, 159213, 159214, 159215, 159216, 159217, 159218, 164764, 164765, 164766, 164767, 164768, 164769, 164770, 164771, 164772, 164773, 164774, 164775, 164776, 164777, 164778, 164779, 164780, 164781, 164782, 164783, 164784, 164785, 164786, 164787, 164788, 164789, 164790, 164791, 164792, 164793, 164794, 164795, 164796, 164797, 164798, 164799, 164800, 164801, 164802, 164803, 164804, 164805, 164806, 164807, 164808, 164809, 164810, 164811, 164812, 164813, 164814, 164815, 164816, 164817, 164818, 164819, 164820, 164821, 164822, 168940, 168941, 168942, 168943, 168944, 168945, 168946, 168947, 168948, 168949, 168950, 168951, 168952, 168953, 168954, 168955, 168956, 168957, 168958, 168959, 168960, 168961, 168962, 168963, 168964, 168965, 168966, 168967, 168968, 168969, 168970, 168971, 168972, 168973, 168974, 168975, 168976, 168977, 168978, 168979, 168980, 168981, 168987;\n\n\n0233-050-200/07613327051643/158865, 158868, 158869, 158872, 158874, 158875, 158878, 158884, 165446, 165448, 165451, 165457, 165458, 165459, 165461, 165462, 165464, 168909, 168910, 168911, 168912, 168913, 168914, 168915, 168916, 168917, 168918, 168919, 168920, 168921, 168923, 168924, 168925, 168926, 168927, 168928", "firm_fei_number": "2936485", "recalling_firm": "Stryker Corporation", "address_1": "5900 Optical Ct", "city": "San Jose", "state": "CA", "postal_code": "95138-1400", "additional_info_contact": "408-754-2000", "reason_for_recall": "Fiber optic cables assembled with not enough epoxy on the proximal end, creating light output issues, which could cause a clinical delay or procedure being converted to open.", "root_cause_description": "Employee error", "action": "On 3/2/23 recall notices were mailed to customers who were asked to do the following:\n1. Inform individuals within your organization who need to be aware of this action.\n2. Identify, remove, and quarantine affected devices.\n3. If affected product is found, call customer service at 1-800-624-4422 (Option 3) or\nemail endocustomersupport@stryker.com to arrange for product return.\n4. Complete and return the Business Reply Form\n\nCustomers with questions can contact EndoRecall@stryker.com", "product_quantity": "5,228", "distribution_pattern": "Worldwide - US Nationwide distribution including in the states of PA, MS, IL, OH, CA, TX, MO, IN, KS, OK, MT, MA, NE, AZ, NV, NJ, IA, WV, MD, KY, FL, NM, NY, CO, WA, NC, VA, LA, ND, WY, HI SC, UT, OR, SD, AR, TN, AK, CT, GA, ID, VT, NH, MN, WI, DE, RI, AL, MI and the countries of NL, PE, AT, CA, TW, PH, SG, KR, CN.", "openfda": { "k_number": [ "K123359", "K992447", "K032430", "K760647", "K964586", "K903790", "K012265", "K832807", "K771739", "K951647", "K091968", "K760176", "K890716", "K963043", "K852951", "K905376", "K000229", "K123956", "K131226", "K093792", "K842609", "K933369", "K993300", "K970598", "K864385", "K121724", "K082813", "K081477", "K942155", "K934531", "K945420" ], "device_name": "Light Source, Fiberoptic, Routine", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2", "registration_number": [ "3011050570", "3008114965", "3002807314", "3003782610", "3009656988", "2085947", "3006697299", "2020550", "3014334038", "3011277660", "3010885402", "9611274", "3007137643", "1421101", "3013868968", "3004215117", "1221934", "3007305485", "2518897", "3010202439", "3011676349", "9615782", "3003418325", "3006765019", "9610877", "3012507533", "3004464325", "3014342096", "3005809810", "3014279513", "3016832577", "3008868758", "1833053", "3008569850", "3014644276", "3012322232", "1320894", "3013247477", "3010120217", "1035968", "9614209", "3006973663", "2434839", "3004001706", "3006984716", "3008837339", "9680718", "3015532525", "3011063460", "9610617", "3007303113", "1222275", "1319480", "9612074", "1221826", "2936485", "9611102", "1017294", "3015612252", "3006546082", "8043903", "3013002167", "3010707607" ], "fei_number": [ "3011050570", "3008114965", "3004084693", "3002807314", "3003782610", "3009656988", "3006697299", "2020550", "3014334038", "3011277660", "3010885402", "3007137643", "1421101", "3002807072", "3013868968", "3004215117", "3002808088", "1221934", "3007305485", "1000080301", "3011676349", "3003418325", "3006765019", "3012507533", "3004464325", "3014342096", "3005809810", "3014279513", "3016832577", "3008868758", "3006149253", "1833053", "3008569850", "3012322232", "3013247477", "3007475226", "3010120217", "1035968", "3006973663", "2434839", "3004001706", "3006984716", "1000121058", "3008837339", "1000120295", "3015532525", "3011063460", "3002808001", "3008185830", "3000204191", "3002806725", "3007303113", "1221826", "2936485", "3002808043", "1017294", "3015612252", "3001451571", "3006546082", "3013002167", "3002808268", "3010707607", "3000280067" ] } } ] }