{ "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": "2026-09-10", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "218944", "product_res_number": "Z-1804-2026", "event_date_initiated": "2026-03-12", "event_date_posted": "2026-04-09", "recall_status": "Open, Classified", "res_event_number": "98504", "product_code": "KCY", "product_description": "Stryker Sustainability Solution Color Cuff 24\" (Yellow) Quick Connect Dual Port Single Bladder REF 5921-024-235\n\nStryker Sustainability Solution Color Cuff 18\" (Red), Quick Connect Dual Port Single Bladder REF 5921-018-135\n\nStryker Sustainability Solution Color Cuff 18\" (Red) Dual Port Single Bladder REF 5921-018-235.", "code_info": "5921-018-135 COLOR CUFF SINGLE PORT, SINGLE BLADDER 18\" (RED), QUICK CONNECT-018-135 COLOR\nUDI-DI code: 50885825016024\nSerial/Lot 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"3009350690", "recalling_firm": "Stryker Sustainability Solutions", "address_1": "1810 W Drake Dr", "city": "Tempe", "state": "AZ", "postal_code": "85283-4327", "additional_info_contact": "Ashley Cupples\n707-530-1457", "reason_for_recall": "Due to potential for tourniquet cuffs to detach from the bladder at the welding connection and result in the cuff not being able to maintain pressure.", "root_cause_description": "Nonconforming Material/Component", "action": "On 03/12/2026, the firm sent via certified mail an \"URGENT: Medical Device Recall\" letter informing customers that there is a potential for Tourniquet Cuffs flange to detach from the bladder where the welding connection is, which may result in the cuff not able to maintain pressure.\n\nCustomers are instructed to:\n1.\tInform individuals within their organization who need to be aware of this action.\n2.\tCheck their internal inventory to locate the affected product. Segregate the affected products, quarantine and discontinue use.\n3.\tComplete the Business Reply Form (Attachment B) and return the completed via email to SSSPFA@stryker.com, or use the QR Code on Attachment B. Response is required.\na.\tIf customers have indicated that product remains in their inventory, a prepaid shipping label will be issued for the return of the product. Credit will be issued to their facility for products returned upon receipt.\n4.\tMaintain awareness of this communication internally until all required actions have been completed within their facility. \n\nFor any additional information or questions please reach out to SSSPFA@stryker.com or Stryker Customer Service at 800-624-4422.", "product_quantity": "56,740 cuffs", "distribution_pattern": "U.S.: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NY, OHJ, OK, OR, PA SC, SD, TN, TX, VA, VT, and WA.\n\nO.U.S.: N/A", "openfda": { "k_number": [ "K162365", "K012632", "K842963", "K945167", "K954201", "K900104", "K910449", "K853802", "K953953", "K871982", "K952038", "K890014", "K791759", "K860463", "K933994", "K910512", "K942303", "K940615", "K123553", "K813231", "K202919", "K860095", "K954103", "K924273", "K112874", "K841558", "K925033", "K050411", "K071140", "K880020", "K780988", "K870784", "K955552", "K840206" ], "registration_number": [ "3002907620", "3011185837", "3011277660", "3016678045", "1818910", "3007997036", "3008381116", "3014313732", "3014830562", "3006128321", "3030153385", "3011683674", "3034520", "3004905643", "3023228837", "1220351", "3015967359", "3010595915", "3032391", "3005173255", "3016764932", "3004116008", "2320762", "3012421607", "3014126909", "3009039068", "3006535925", "3013783488", "3012494290", "3033511104", "3012536737", "3010759902", "3012276218", "1048735", "2029275", "1528668", "3013730933", "2528981", "3033773618", "3025434447", "9611559", "3016445580", "3020163307", "3004727093", "3010123014", "1649518", "3010883047", "1058584", "1421307", "3030516433", "2011171", "9611283", "1822565", "3015280549", "3015225571", "3014739961", "3031887985", "3006950086", "3005698350", "3004824601", "8010482", "1018470", "3010273872", "2650143", "9613910", "3007478714", "3010291427", "3014023545", "3009605245", "3015495690", "3015207155", "3015542154", "1423537", "9680215", "9681444", "9680579", "1422634", "1526350", "3006975482", "3008264111", "1043214", "3030733800", "2184171", "3010190204", "2032098", "3013846070", "1721504", "8040278", "3016950436", "1921846", "3015309643", "3011642792", "1650907", "1720929", "3038700849", "3016965559", "3005621729", "3009056984", "8010939", "3033589330", "3031700059", "3009350690", "2648666", "1722028", "3006703573", "3045058049", "3010410654", "3003244954" ], "fei_number": [ "3002907620", "1000292048", "3011185837", "3011277660", "3016678045", "1818910", "3007997036", "3008381116", "3014313732", "3014830562", "3006128321", "3030153385", "3001236277", "3003058448", "3011683674", "3004905643", "3023228837", "1220351", "3015967359", "3010595915", "3005173255", "3016764932", "3004116008", "3004216008", "3012421607", "3014126909", "3009039068", "3006535925", "3013783488", "3012494290", "3033511104", "3012536737", "3010759902", "3012276218", "1048735", "3013730933", "2528981", "3033773618", "3025434447", "3016445580", "1000117351", "3020163307", "3004727093", "3010123014", "1000219637", "1421307", "3030516433", "3003350313", "1000136409", "2011171", "3015280549", "3002806816", "3001236905", "3015225571", "3014739961", "3031887985", "3006950086", "3005698350", "3004824601", "1018470", "3010273872", "3004574120", "3003748933", "3007478714", "3010291427", "3012599796", "3014023545", "3009605245", "2648209", "3015495690", "1000306431", "3015207155", "3015542154", "1000514656", "1000220733", "1526350", "3006975482", "3008264111", "1043214", "1000139815", "3003255513", "3030733800", "3010190204", "3013846070", "1721504", "3016950436", "1921846", "3015309643", "3011642792", "1720929", "3001084824", "3038700849", "3002299608", "3002681132", "3016965559", "3003040625", "3005621729", "3009056984", "3033589330", "3031700059", "3009350690", "3002808440", "2648666", "3006703573", "3045058049", "1000203464", "3010410654", "3003244954" ], "device_name": "Tourniquet, Pneumatic", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.5910", "device_class": "1" } } ] }