{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "191893", "product_res_number": "Z-0664-2022", "event_date_initiated": "2022-01-21", "event_date_created": "2022-02-22", "recall_status": "Terminated", "event_date_terminated": "2025-02-26", "res_event_number": "89535", "product_code": "KCY", "product_description": "REF: 5921-018-135, Stryker Color Cuff, 18\" (Red), Quick Connect Single Port, Single Bladder", "code_info": "Lot # 12983349", "firm_fei_number": "3009350690", "recalling_firm": "Stryker Sustainability Solutions", "address_1": "1810 W Drake Dr", "city": "Tempe", "state": "AZ", "postal_code": "85283-4327", "additional_info_contact": "Stryker Sustainability Solutions Complaint Hotline\n888-763-8803", "reason_for_recall": "Mislabeling; dual-bladder tourniquet cuffs are labeled as single-bladder inflatable cuffs.", "root_cause_description": "Labeling mix-ups", "action": "On February 4, 2022, Stryker issued an \"Urgent: Medical Device Recall notification\" to all affected customers. In addition to informing consignees about the recalled product, the firm ask customers to take the following actions: \n\n1.) Please check your inventory for the devices from the affected lot and remove them from their point of use.\n\n2.) Please complete the Urgent Medical Device Recall Business Reply Form (page 3) and indicate if any of the affected product remains in your inventory. Please return this completed form through one of the following methods:\n\na. Email: SSSPFA@stryker.com\nb. To your Stryker s Sustainability Solutions Sales Representative\nc. Fax: 480-763-5345\n\nThis form must be completed and returned to Stryker even if no affected product is found.\n\n3.) Maintain awareness of this communication internally until all required actions have been completed within your facility.\n\nIf any of the affected products have been forwarded to additional facilities (including but not limited to distribution warehouses), please contact these facilities and communicate this recall to them. Please instruct these facilities to complete the Business Reply Form (page 3) and return the completed form either via email to\nSSSPFA@stryker.com, to their Stryker s Sustainability Solutions sales representative, or via fax to 480-763-5345.\n\nAlternatively, provide contact details so Stryker can inform the recipients appropriately.\nIf the form indicates that any affected product remains in your inventory, a prepaid shipping label will be issued for the return of the product. Credit will be issued to your facility for all devices that are returned prior to May 1st, 2022.\n\n4.) Adverse reactions or quality problems experienced with the use of this product should be reported to:\n\n\" Stryker s Sustainability Solutions Complaint Hotline: +1-888-763-8803\n\" http://www.stryker.com/productexperience\n\" The FDA s MedWatch Adverse Event Reporting program either online, by", "product_quantity": "40 units", "distribution_pattern": "US: KS OK TX\nOUS: None", "openfda": { "k_number": [ "K954103", "K071140", "K880020", "K162365", "K910449", "K900104", "K813231", "K945167", "K112874", "K910512", "K202919", "K860095", "K791759", "K841558", "K853802", "K940615", "K942303", "K870784", "K955552", "K012632", "K840206", "K925033", "K860463", "K871982", "K953953", "K050411", "K954201", "K952038", "K890014", "K842963", "K924273", "K933994", "K780988", "K123553" ], "registration_number": [ "3004116008", "3012276218", "1650907", "3033511104", "3009039068", "3012421607", "2032098", "2650143", "1018470", "8010482", "3025434447", "1048735", "3016445580", "3016678045", "3020163307", "3015225571", "1721504", "3005621729", "3016950436", "3006535925", "3010883047", "3038700849", "3013730933", "3006128321", "8040278", "2011171", "1720929", "3016965559", "1722028", "3031887985", "3011642792", "3004905643", "1528668", "3010190204", "3030733800", "3033589330", "9680579", "3010123014", "3014023545", "3003244954", "3004727093", "3014830562", "1921846", "3004824601", "2528981", "9680215", "3014126909", "3014739961", "3015967359", "3009605245", "1421307", "3010410654", "3012494290", "3033773618", "2648666", "3011185837", "3009350690", "3011683674", "3006703573", "3010595915", "3011277660", "3009056984", "3013846070", "3002907620", "2029275", "3010759902", "3014313732", "9681444", "3030153385", "1043214", "1822565", "3007997036", "2184171", "1649518", "9611283", "9613910", "3031700059", "1422634", "1526350", "3012536737", "3015309643", "3008264111", "3034520", "3015495690", "3032391", "1423537", "9611559", "1220351", "3015207155", "3045058049", "3013783488", "3005173255", "3007478714", "3005698350", "3015542154", "3023228837", "1058584", "3010273872", "2320762", "3015280549", "3006975482", "3030516433", "3006950086", "3008381116", "3009750712", "8010939", "3016764932", "1818910", "3010291427" ], "fei_number": [ "3004116008", "3012276218", "3033511104", "3003748933", "3009039068", "3002808440", "3012421607", "1000306431", "1018470", "3025434447", "1048735", "3016445580", "3016678045", "3020163307", "3015225571", "1721504", "3005621729", "3016950436", "3006535925", "3038700849", "3013730933", "3006128321", "2011171", "1720929", "3016965559", "3031887985", "3002299608", "3011642792", "3004905643", "3010190204", "3002681132", "3030733800", "3033589330", "3010123014", "3014023545", "3003244954", "3004727093", "3014830562", "1921846", "3004824601", "2528981", "3014126909", "3014739961", "3004574120", "3015967359", "3009605245", "1421307", "1000219637", "3010410654", "3012494290", "3033773618", "2648666", "3011185837", "3003255513", "3009350690", "3011683674", "1000514656", "3006703573", "3010595915", "3011277660", "3009056984", "3013846070", "3002907620", "3010759902", "3014313732", "3030153385", "1043214", "3001084824", "1000136409", "3007997036", "3001236905", "3002806816", "3031700059", "1000117351", "1526350", "3001236277", "3012536737", "3015309643", "3008264111", "3015495690", "3003058448", "1000203464", "3003350313", "1220351", "3015207155", "3045058049", "3013783488", "3012599796", "3005173255", "3007478714", "3005698350", "3015542154", "3023228837", "3010273872", "3015280549", "1000292048", "3006975482", "1000220733", "3030516433", "3006950086", "1000139815", "3004216008", "3008381116", "2648209", "3009750712", "3016764932", "1818910", "3003040625", "3010291427" ], "device_name": "Tourniquet, Pneumatic", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.5910", "device_class": "1" } } ] }