{ "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": "2026-09-12", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "218033", "product_res_number": "Z-1544-2026", "event_date_initiated": "2026-01-21", "event_date_posted": "2026-03-10", "recall_status": "Open, Classified", "res_event_number": "98257", "product_code": "MKJ", "pma_numbers": [ "P160012" ], "product_description": "PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes\nCatalog Numbers: 11101-000016\nUDI-DI code: 00721902629013\n\nCatalog Number: 11101-000017\nUDI-DI code: 00721902682483\n\nInfant/Child Reduced Energy Defibrillation Electrodes are pre gelled, self-adhesive, therapy electrodes that allow hands free defibrillation. These electrodes reduce the energy delivered to the patient by a factor of 4:1. The Infant/child reduced energy defibrillation electrodes are therapy electrodes designed to allow personnel who are trained on AED device operation and in basic life support, or other physician authorized emergency medical response systems, to safely and effectively defibrillate infants and children who are less than 8 years old or weigh less than 25kg (55lbs).", "code_info": "Catalog Numbers: 11101-000016\nUDI-DI code: 00721902629013\n\nCatalog Number: 11101-000017\nUDI-DI code: 00721902682483\n\nLot Numbers:\n315303, 315639, 315858, 316007, 320529, 318931", "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 pediatric defibrillator electrode delamination", "root_cause_description": "Unknown/Undetermined by firm", "action": "On 01/21/2026, the firm sent via certified mail an \"Urgent: Medical Device Recall\" letter to customer informing them that Stryker was notified of complaints that the pediatric electrodes were experiencing gel delamination and could lead to a noisy or distorted ECG waveform and in addition may deliver energy to a patient without the electrode's gel barrier may result in burns.\n\nCustomers are instructed to:\n1. Immediately check internal inventory to locate the affected product as listed above.\n2. Stop use and segregate and quarantine the affected product.\n3. On the business reply form, indicate if an affected electrode is in their possession.\n4. Return the business reply form by email to RSRecall@Stryker.com to confirm receipt of this notification.\n5. Upon receipt of the completed business reply form, Stryker will contact you to arrange for replacement of the electrode.\n6. A return material authorization (RMA) will be provided when a replacement electrode is sent to return the affected electrodes back to Stryker.\n7. Maintain awareness of this communication internally until all required actions have been completed within their facility. Ensure this letter is kept with the affected device until the correction has been completed.\n8. Inform Stryker if any of the subject electrodes have been distributed to other organizations. If so, provide contact details, so Stryker can inform the recipients appropriately.\n\nFor Questions - contact Customer Service +1 800 787 9537, option 2, from 8:00\nAM to 7:00 PM (Eastern Time), Monday Friday or by email at medtechsup@stryker.com.", "product_quantity": "16,499 electrodes (US/OUS: 8327/8172)", "distribution_pattern": "Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. The countries of Australia, Canada, Hong Kong, Japan, Mexico, Malaysia, Netherlands, New Zealand, and Taiwan.", "openfda": { "k_number": [ "K021453", "K030898", "K091943", "K012197", "K860676", "K993533", "K122758", "K120350", "K051632", "K011388", "K983287", "K990106", "K131550", "K892065", "K110168", "K052057", "K032421", "K121853", "K942850", "K092391", "K020984", "K110825", "K955828", "K993072", "K062537", "K142709", "K091548", "K120536", "K033771", "K082090", "K081828", "K110978", "K133239", "K051134", "K122600", "K981737", "K003548", "K072923", "K982710", "K981802", "K042007", "K965117", "K011144", "K110526", "K014157", "K081371", "K002079", "K010257", "K042417", "K892005", "K883341", "K100565", "K031987", "K130684", "K090989", "K103186", "K952101", "K943698", "K990762", "K991910", "K110361", "K133484", "K020715", "K071025", "K926172", "K003565", "K111594", "K091265", "K133659", "K031187", "K972418", "K112432", "K113787", "K033896", "K070455", "K041459", "K150055", "K970741", "K042088", "K010214", "K072430", "K133441", "K003228", "K980857", "K063375", "K143714", "K993745", "K103567", "K142430", "K051076", "K040056", "K061707", "K040479", "K120406", "K123881", "K023854", "K041892", "K110742", "K000638", "K982992", "K130153", "K013425", "K073716", "K984286", "K970391", "K122839", "K993036", "K080232", "K082937", "K040256", "K020203", "K020743", "K112761", "K960329", "K032051", "K002232", "K091561", "K080903", "K060934", "K934692", "K072812", "K991871", "K002445", "K013896", "K932931", "K042404", "K020288", "K925936", "K021168", "K073089", "K012428", "K972241", "K120907", "K955923", "K984582", "K102972", "K131494", "K033275", "K081081", "K940445", "K072233", "K051475", "K080421", "K133269", "K052161", "K111693", "K001725", "K052316", "K955854", "K141231", "K955890", "K052465", "K033642", "K142803", "K935922", "K050004", "K142915", "K003819", "K092598", "K012030", "K972970", "K964991", "K072596", "K982264", "K954504", "K941262", "K983307", "K141795", "K896919", "K955882", "K130454", "K033474", "K040404", "K033144", "K932028", "K060559", "K040637", "K941970", "K032439", "K062233", "K954957", "K883344", "K853564", "K041067", "K102496", "K063510", "K971149", "K110154", "K971148", "K022929", "K040438", "K870622", "K883584", "K983393", "K991556", "K982025", "K041883", "K011901", "K131525", "K062177", "K040775", "K063119", "K992977", "K970719", "K012766", "K022210", "K062970", "K962359", "K992543", "K002280", "K011541", "K081259", "K010918", "K953204", "K010207", "K150198", "K954609", "K973486", "K141774", "K022732", "K882067", "K942344", "K955628", "K002806", "K991007", "K082861", "K014209", "K010634" ], "pma_number": [ "P160015", "P160032", "P160034", "P190013", "P170018", "P180028", "P210015", "P200004", "P160012", "P160026", "P160008", "P160033", "P200005", "P160028", "P190007", "P160022", "P200007" ], "registration_number": [ "3013500228", "", "3002807314", "3003521780", "3015997711", "3009886119", "3004123209", "3012607778", "3010703925", "3003537036", "3020460367", "3006108746", "3009077524", "3021632375", "3026007685", "2112020", "3003800159", "3013826848", "3003867964", "3030446844", "3010317211", "3014579161", "1218058", "1320894", "3021559257", "1219103", "3005621729", "3015134086", "3013596024", "3008717264", "3010783192", "3004906872", "3002714378", "3005906887", "3029871637", "9681191", "3030733800", "3010030355", "3038259592", "1220908", "3030677", "3014572985", "3004035727", "3012104670", "1921846", "1720929", "3000126629", "3013517171", "3043226252", "8020045", "3012972516", "3012494290", "3007029079", "3011823740", "3010839093", "1223925", "1930027", "3017422354", "3027815", "1423537", "3012502601", "3013557562", "3026976873", "1317188", "1423662", "2132111", "9681860", "3015876" ], "fei_number": [ "3013500228", "", "3002807314", "3003521780", "3015997711", "3009886119", "3004123209", "3012607778", "3010703925", "3003537036", "3020460367", "1000148701", "3006108746", "3009077524", "1000305720", "3021632375", "3026007685", "3013826848", "2112020", "3003867964", "3003800159", "3030446844", "3010317211", "3014579161", "1218058", "3021559257", "3005621729", "3015134086", "3013596024", "6736", "3008717264", "3010783192", "3004906872", "3002714378", "3005906887", "3029871637", "1000140026", "3030733800", "1000127185", "3010030355", "3038259592", "3008207730", "1220908", "3014572985", "3004035727", "3012104670", "1921846", "1720929", "3000126629", "3013517171", "3043226252", "3007029079", "3012972516", "3012494290", "3001236905", "3010839093", "3011823740", "1930027", "3017422354", "3003491392", "3000215273", "3012502601", "3013557562", "3026976873", "3001451571", "1000524572", "1317188", "3015876" ], "device_name": "Automated External Defibrillators (Non-Wearable)", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.5310", "device_class": "3" } } ] }