{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 72 } }, "results": [ { "cfres_id": "209803", "product_res_number": "Z-0142-2025", "event_date_initiated": "2024-08-09", "event_date_posted": "2024-10-22", "recall_status": "Open, Classified", "res_event_number": "95242", "product_code": "LDD", "k_numbers": [ "K182503" ], "product_description": "STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20\nSTERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP15\n\nDefibrillation is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Synchronized cardioversion is indicated for the treatment of atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, supraventricular tachycardia, and in relatively stable patients, ventricular tachycardia.", "code_info": "LP20\nModel/Catalog Number: 11131-000040\nUDI-DI codes: 00883873863558\nPart Number: 3317813-001\nSerial Numbers:\n101648901\n86557878\n87141562\n88458193\n88482392\n93989670\nPart Number: 3317813-005\nSerial Number: 107741863\n\nModel/Catalog Number: 11131-000041\nUDI-DI code: 00883873863534\nPart Number: 3317813-002\nSerial Numbers:\n86287034\n86949592\n90445090\n91624045\n93441890\nPart Number: 3317813-006\nSerial Number: 107556559\n\nModel/Catalog Number: 11131-000042\nUDI-DI code: 00883873863527\nPart Number: 3317813-003\nSerial Numbers:\n100198569\n100759224\n101002312\n101042672\n101383090\n84830138\n84881382\n84915416\n86240215\n86260453\n86557878\n86949593\n87794908\n90445091\n91380577\n92185462\n96496375\n96496376\n96496377\n97059498\nPart Number: 3317813-007\nSerial Numbers:\n105817428\n106332158\n107556560\n\nModel/Catalog Number: 11131-000043\nUDI-DI code: 00883873863510\nPart Number: 3317813-004\nSerial Numbers:\n101506304\n86949594\n90445092\n\nLP15\nModel/Catalog Number: 11131-000044\nUDI-DI code: 00883873863503\nPart Number: 3317814-001\nSerial Numbers:\n90445093\n93441892\n98719352\n98719353\n99649024\n99649025\nPart Number: 3317814-005\nSerial Number: 107124577\n\nModel/Catalog Number: 11131-000045\nUDI-DI code: 00883873863497\nPart Number: 3317814-003\nSerial Numbers:\n101888461\n101888462\n101888463\n102107169\n103669336\n103669337\n104125087\n104129892\n104440600\n86280420\n90445095\n92556517\n92871913\n95836040\n97111384\n98719364\n98719365\n98813631\n99692098\nPart Number: 3317814-007\nSerial Numbers:\n106555464\n106721716\n106917875\n106968460\n107445069\n107741891\n\nModel/Catalog Number: 11131-000046\nUDI-DI code: 00883873863480\nPart Number: 3317814-004\nSerial Numbers:\n90445096\n98719376\n98813643\n98990261\n99692108\nPart Number: 3317814-008\nSerial Numbers: 107124605\n\nModel/Catalog Number: 11131-000047\nUDI-DI code: 00883873863213\nPart Number: 3317814-002\nSerial Numbers:\n84830141\n90445094\n91515844\n92556516\n92871911\n93441893\n98719358\n98719359\n99692092\nPart Number: 3317814-006\nSerial Numbers:\n107078533\n107445059", "firm_fei_number": "3015876", "recalling_firm": "Physio-Control, Inc.", "address_1": "11811 Willows Rd Ne", "city": "Redmond", "state": "WA", "postal_code": "98052-2003", "additional_info_contact": "Joyce Staggs\n425-867-4597", "reason_for_recall": "Due to customer complaints and out of box failures, the firm is conducting a voluntary recall as a result of product failures (cracks and over-molding separation of the sterilizable internal defibrillation paddles.", "root_cause_description": "Under Investigation by firm", "action": "On 09/27/2024, the firm send an \"URGENT: MEDICAL DEVICE CORRECTION\" Letter via US mail to customers informing them that Stryker has received several complaint reports indicating issues with Internal Paddles - 1) Paddles are not reaching the expected cleaning and sterilization cycle count designated in the Instructions for Use and are showing signs of cracking, and 2) Internal Paddles having a noticeable material separation between the white and gray silicone overmold material on the grip of the handle.\n\nCustomer are instructed to:\n1. Immediately check your internal inventory to locate the product listed on the attached business reply form.\n2. To confirm receipt of this Medical Device Notice and understanding of the provided information, please email the enclosed Business Reply Form (BRF) by October 15th, 2024 to RSRecall@Stryker.com\n3. It is important to follow the steps as outlined in the Pre-Surgical Check section of the Instructions for Use (IFU). If any damage or malfunction is found, remove the internal paddles from use immediately and contact your local Stryker representative for assistance.\n4. Please continue to follow the Instructions for Use for the Sterilizable Internal Defibrillation Paddles for additional troubleshooting steps.\n\nFor questions/assistance - contact Stryker Customer Service at +1 800 787 9537, option 2, from 8:00 AM to 7:00 PM (Eastern Time), Monday Friday or by email at medtechsup@stryker.com.", "product_quantity": "3,617 devices (US-3315 and O.U.S - 302 devices)", "distribution_pattern": "Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, and WV. The countries of Australia, Canada, Netherlands, and New Zealand.", "openfda": { "k_number": [ "K812520", "K885186", "K911402", "K923297", "K823931", "K871136", "K882235", "K914971", "K200849", "K140502", "K982896", "K895009", "K840900", "K871224", "K874204", "K831696", "K910144", "K920086", "K911665", "K891122", "K902478", "K931803", "K800937", "K840258", "K934015", "K801544", "K813471", "K871135", "K902429", "K822961", "K852799", "K911604", "K970481", "K853439", "K103651", "K911662", "K931804", "K032691", "K913484", "K103334", "K922315", "K822294", "K911456", "K971355", "K895113", "K842624", "K800936", "K931787", "K930548", "K931053", "K812519", "K103783", "K100654", "K895533", "K840167", "K852808", "K880575", "K874091", "K904466", "K843396", "K894355", "K823933", "K863899", "K781678", "K905510", "K150349", "K935111", "K922563", "K962551", "K964469", "K904462", "K922227", "K812317", "K895651", "K842235", "K912587", "K842667", "K902782", "K905065", "K012274", "K851092", "K872793", "K854175", "K921487", "K912966", "K935083", "K900169", "K030417", "K921765", "K851924", "K895662", "K903018", "K910634", "K203231", "K971194", "K842312", "K832833", "K894356", "K882337", "K941995", "K852905", "K952085", "K934508", "K951110", "K811638", "K893990", "K182503", "K843229", "K832827", "K855082", "K863303", "K921606", "K883617", "K993205", "K851485", "K931805", "K890079", "K903657", "K912621", "K844740", "K935674", "K851931", "K920990", "K902288", "K831056", "K823828", "K893403", "K931266", "K823268", "K812586", "K874697", "K042302", "K902590", "K844447", "K895379", "K854307", "K810237", "K971436", "K895032", "K896903", "K864257", "K881153", "K011461", "K914458", "K921666", "K081442", "K844103", "K911455", "K922172", "K850618", "K863404", "K910754", "K895185", "K853354", "K780416", "K103159", "K833751", "K863405", "K081574", "K963781", "K840246", "K102468", "K922173", "K923864", "K822617", "K940842" ], "registration_number": [ "3004035727", "2246340", "3009077524", "3014579161", "3005677568", "2183890", "8030978", "3013826848", "1223925", "3008717264", "1066270", "3010317211", "3004906872", "3003832357", "3010783192", "3003615065", "3030677", "3013596024", "3012104670", "3015876", "3013557562", "3000143502", "3003800159", "3017422354", "1317188", "3007305485", "1320894", "1417592", "1220908", "3013500228", "1930027", "3011823740", "3000126629", "3015997711", "3005521864", "3003072803", "3010703925", "3007029079" ], "fei_number": [ "3004035727", "2246340", "3009077524", "1000524572", "3001451571", "3014579161", "1000305720", "3005677568", "2183890", "3013826848", "3000957797", "3008717264", "3010317211", "3004906872", "3003832357", "3010783192", "3003615065", "3013596024", "3012104670", "3015876", "3013557562", "3000143502", "3003800159", "3017422354", "1317188", "3007305485", "3002808182", "1417592", "1220908", "3013500228", "1930027", "3011823740", "3000126629", "3015997711", "3005521864", "3003072803", "3010703925", "3007029079" ], "device_name": "Dc-Defibrillator, Low-Energy, (Including Paddles)", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.5300", "device_class": "2" } } ] }