{ "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": "219497", "product_res_number": "Z-2166-2026", "event_date_initiated": "2026-04-09", "event_date_posted": "2026-05-12", "recall_status": "Open, Classified", "res_event_number": "98696", "product_code": "HIG", "k_numbers": [ "K172048" ], "product_description": "Thermedx FluidSmart Urology Tube Set REF LL0006\nUDI-DI code: 00860936000365\n\nThe FluidSmart Tube Sets are intended to be used with the FluidSmart Fluid Management System, which is intended for irrigation and fluid warming in laparoscopic procedures, and distention, fluid warming, and volume/deficit measurements in endoscopic procedures within gynecology, urology, and orthopedic disciplines.", "code_info": "Catalog Number: LL0006\nUDI-DI code: 00860936000365\nLot Number: B000576601", "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": "Melanie Shepard\n408-754-2000", "reason_for_recall": "Due to nonconforming products being inadvertently distributed.", "root_cause_description": "Process change control", "action": "On 04/09/2026, the firm sent via USPS Certified Mail an \"URGENT: MEDICAL DEVICE RECALL\" Letter to customers that Stryker identified that certain lots of FluidSmart tube sets were manufactured with an incorrect pressure relief valve specification. This defect may prevent the pressure relief valve from activating at the intended pressure in the event of a capital device over pressure failure. One lot (Lot B000576601, quantity 10) impacted by this nonconformance was inadvertently shipped to a customer.\n\nCustomers are instructed to:\n1. Inform individuals within their organization who need to be aware of this action.\n2. Check internal inventory to locate the product listed in the product affected grid.\n3. If affected product is found, stop use immediately, segregate the product and call Stryker Customer Service at 1-800-624-4422\n(Option 3) or email endocustomersupport@stryker.com to arrange for product return and issuance of credit or replacement (upon availability).\na. Remove the affected products, quarantine, and discontinue use of the identified product.\nb. Please complete Business Reply Form on Attachment A on Page 2 and return it to EndoRecall@stryker.com.\n4. If affected product is NOT found:\na. Please complete Business Reply Form on Attachment A on Page 2 and return it to EndoRecall@stryker.com.\n5. Maintain awareness of this communication internally until all required actions have been completed within your facility. Response is required.\n\nFor questions - EndoRecall@stryker.com or 1-800-624-4422 (Option 3).", "product_quantity": "10 tube sets", "distribution_pattern": "U.S. Nationwide distribution in the state of GA.", "openfda": { "k_number": [ "K172040", "K031616", "K983889", "K991799", "K894259", "K933847", "K930912", "K912789", "K240886", "K891028", "K933873", "K091939", "K210628", "K971492", "K931606", "K895907", "K251273", "K950961", "K936231", "K881680", "K031213", "K201355", "K022449", "K924523", "K941743", "K933384", "K842943", "K922632", "K964136", "K905706", "K982867", "K011876", "K901288", "K180735", "K000806", "K892001", "K123732", "K873527", "K921871", "K110852", "K922197", "K112642", "K011069", "K905495", "K911844", "K133799", "K900908", "K173489", "K970078", "K180825", "K934866", "K172048", "K895659", "K261706", "K872860", "K912498", "K961091" ], "registration_number": [ "3043236281", "3011011193", "2521453", "9612445", "3042158861", "2953359", "3007200016", "3009746061", "3013557562", "3008837339", "3012356141", "3007305485", "3003790304", "3001556604", "2246552", "3006330030", "1219930", "3006131984", "9610773", "2936485", "3005382983", "3010273872", "9610617", "3008044552", "3018094310", "3010707607", "2020550", "3004111573", "2511556", "3002907620", "1423662", "3033043422", "2124215", "2954783", "3009538961", "3008810357", "3015512350", "3012322232", "9611102", "9614434", "3014279513", "3014342096", "3016678045", "3013247477", "3005136445", "1222780", "9616693", "3020976354", "1220477", "9710641", "3014461810", "3007113251", "3005099803", "8043980", "9680340", "1526611", "3017616393", "3010432890", "3003542872", "2031963", "3007495879", "1216677", "3011050570", "1221826", "1424263", "3010202439" ], "fei_number": [ "3043236281", "3011011193", "1000434163", "2521453", "3002975342", "3042158861", "3007200016", "3009746061", "3013557562", "3008837339", "3012356141", "3002914049", "3007305485", "3002807433", "3003790304", "3002618605", "3001556604", "2246552", "3003186357", "3006330030", "1219930", "3006131984", "3003565456", "1000120743", "2936485", "3010273872", "3008044552", "3003015552", "3018094310", "3010707607", "3000215273", "2020550", "3002808273", "3004111573", "2511556", "3002907620", "3033043422", "2124215", "3009538961", "3008810357", "3015512350", "3012322232", "3014279513", "3014342096", "3016678045", "3013247477", "3005136445", "3007475226", "3020976354", "1220477", "3014461810", "3007113251", "3005099803", "1526611", "3017616393", "3010432890", "3003542872", "3007495879", "1216677", "3002808001", "3002808268", "3011050570", "1221826", "3002807798", "3000215205", "3005382983" ], "device_name": "Insufflator, Hysteroscopic", "medical_specialty_description": "Obstetrics/Gynecology", "regulation_number": "884.1700", "device_class": "2" } } ] }