{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "214628", "product_res_number": "Z-2277-2025", "event_date_initiated": "2025-07-02", "event_date_posted": "2025-08-07", "recall_status": "Open, Classified", "res_event_number": "97133", "product_code": "KCY", "product_description": "Stryker SmartPump Tourniquet, disposable sterile (single use)\r\n\r\nDISP 18X3,1BLA,1PRT\r\nQUICK / 5921-018-135;\r\n\r\nDISP 18X3,1BLA,2PRT\r\nQUICK / 5921-018-235;\r\n\r\nDISP 24X4,1BLA, 2PRT\r\nQUICK / 5921-024-235", "code_info": "5921-018-135 GTIN 07613154599257\n5921-018-235 GTIN 07613154599295\n5921-024-235 GTIN 07613154599370", "firm_fei_number": "3015967359", "recalling_firm": "Stryker Corporation", "address_1": "1941 Stryker Way", "city": "Portage", "state": "MI", "postal_code": "49002-9711", "additional_info_contact": "Richard Kensinger\n269-800-1941", "reason_for_recall": "Tourniquet cuff flange may become detached from the bladder. If leak occurs during the procedure, there may be risk of hemorrhage, resulting in blood loss greater than expected. Other serious risks include cerebral hypotension and cardiovascular collapse and arrest, risking stroke or death. Specific to IVRA, patient toxicity may also occur due to rapid systemic absorption of anesthetics.", "root_cause_description": "Equipment maintenance", "action": "On July 2, 2025, the firm notified customers via Urgent Medical Device Recall letters. Customers were instructed to locate and quarantine any affected products at their facility and return an enclosed business reply form to the firm. Stryker will provide a shipping label to return the affected product, and credit will be issued to affected customers upon receipt of the recalled product.", "product_quantity": "233.230", "distribution_pattern": "Domestic US distribution nationwide. International distribution to Australia\nCanada\nHong Kong\nIndia\nMalaysia\nNetherlands\nNew Zealand\nSingapore\nSweden\nThailand\nUnited Kingdom", "openfda": { "k_number": [ "K925033", "K780988", "K942303", "K123553", "K880020", "K954103", "K202919", "K860463", "K813231", "K162365", "K012632", "K955552", "K112874", "K910449", "K900104", "K071140", "K860095", "K871982", "K791759", "K840206", "K842963", "K933994", "K924273", "K841558", "K945167", "K853802", "K953953", "K050411", "K954201", "K870784", "K910512", "K890014", "K940615", "K952038" ], "registration_number": [ "1650907", "1720929", "3016678045", "3005621729", "1721504", "1822565", "3012494290", "8040278", "3004905643", "3009039068", "1649518", "3032391", "3010759902", "3031887985", "3012421607", "3016445580", "3034520", "3045058049", "9611559", "1423537", "3011277660", "3016950436", "3006975482", "1048735", "1921846", "3006535925", "3030153385", "3038700849", "3011683674", "3014830562", "3030733800", "2320762", "3013783488", "3030516433", "3033511104", "3004824601", "3010410654", "3010273872", "3008381116", "3002907620", "3015495690", "3013846070", "3033589330", "3011185837", "3014739961", "3010595915", "3015967359", "8010939", "3015542154", "1528668", "9681444", "2528981", "9613910", "2650143", "3009350690", "3025434447", "3010883047", "9680215", "8010482", "3020163307", "1422634", "2184171", "3015309643", "3009605245", "1058584", "1722028", "3010291427", "3006128321", "1043214", "3031700059", "3012276218", "3006703573", "2648666", "1526350", "3023228837", "3010123014", "3008264111", "3004116008", "1421307", "3005173255", "3016965559", "3004727093", "3015225571", "3009056984", "2011171", "3011642792", "3014313732", "3003244954", "2032098", "1220351", "3005698350", "3033773618", "3015207155", "9680579", "1818910", "3006950086", "3007478714", "3010190204", "3015280549", "3016764932", "3013730933", "9611283", "1018470", "3007997036", "3012536737", "3014126909", "2029275", "3014023545" ], "fei_number": [ "1720929", "3016678045", "3005621729", "1721504", "3012494290", "3004905643", "3001084824", "3009039068", "3004574120", "3010759902", "3031887985", "1000306431", "3003058448", "3012421607", "3016445580", "3045058049", "3011277660", "3016950436", "3006975482", "3001236905", "1048735", "1921846", "3006535925", "3030153385", "3003255513", "3038700849", "3011683674", "3014830562", "3030733800", "3013783488", "3030516433", "3033511104", "3004824601", "3010410654", "3010273872", "3001236277", "3008381116", "3002907620", "3015495690", "3013846070", "3033589330", "3002806816", "3011185837", "3014739961", "3010595915", "3015967359", "3015542154", "2528981", "3009350690", "3025434447", "3020163307", "1000514656", "3015309643", "3009605245", "3010291427", "3006128321", "1043214", "3031700059", "1000117351", "3012276218", "3002681132", "3012599796", "3006703573", "1000219637", "1000139815", "3004216008", "3002808440", "2648666", "1526350", "3023228837", "3010123014", "1000220733", "3008264111", "3004116008", "1421307", "3005173255", "3016965559", "3004727093", "3002299608", "3015225571", "2648209", "3009056984", "2011171", "3011642792", "3014313732", "1000136409", "3003244954", "1220351", "3005698350", "3003748933", "1000203464", "3033773618", "3015207155", "1818910", "3006950086", "3007478714", "3010190204", "3015280549", "3016764932", "3003040625", "3013730933", "1000292048", "1018470", "3007997036", "3012536737", "3003350313", "3014126909", "3014023545" ], "device_name": "Tourniquet, Pneumatic", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.5910", "device_class": "1" } } ] }