{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "216250", "product_res_number": "Z-0288-2026", "event_date_initiated": "2025-09-18", "event_date_posted": "2025-10-23", "recall_status": "Open, Classified", "res_event_number": "97651", "product_code": "MKJ", "pma_numbers": [ "P160008" ], "product_description": "HeartSine Pad-Pak, REF: PAD-PAK-01, PAD-PAK-02, PAD-PAK-03, PAD-PAK-04, PAD-PAK-07, PAD-PAK-03J, PAD-PAK-04J", "code_info": "PAD-PAK-01, Lot: H017-002-174 and H047-002-100, UDI: 0506016712046;\nPAD-PAK-02, Lot: H023-002-051, UDI: 0506016712047;\nPAD-PAK-03, Lot: H017-002-173, H047-002-101, UDI: 0506016712123;\nPAD-PAK-04, Lot: H023-002-050, UDI: 0506016712124;\nPAD-PAK-07, Lot: H017-002-178, UDI: 0506016712448;\nPAD-PAK-03J, Lot: H017-002-071 and H047-002-035, UDI: 0506016712475;\nPAD-PAK-04J, Lot: H023-002-009, UDI: 0506016712476", "firm_fei_number": "3004123209", "recalling_firm": "HeartSine Technologies Ltd", "address_1": "207 Airport Road West", "city": "Belfast", "country": "United Kingdom", "additional_info_contact": "1425-867-5497", "reason_for_recall": "Due to customer complaints, defibrillator pads may contain damage pins that disrupt the mechanical fit and electrical contact.", "root_cause_description": "Under Investigation by firm", "action": "On September 18, 2025, HeartSine (Stryker) issued a \"Urgent: Medical Device Recall Notification.\" HeartSine is asking consignees to take the following actions: \n\n1. To ensure the device works correctly in an emergency, follow the instructions within the customer notification. \nA. Check the expiry date on your Pad-Pak\nB. Check for bent locator pins.\nC. Follow Pad-Paks insertion instructions. \nD. Submit your response online at: heartsincerecall.com. A response is required in all instances. \nE. Maintain Awareness\nF. If you have further distributed affected product(s), please forward a copy of this notice to the new responsible party and email RSRecall@stryker.com with both the location to which the product(s) was/were further distributed to and the quantity and lot number for any Pad-Paks that have been disposed of.\n\nIf you have any questions or concerns, please contact Stryker Customer Service at +1 800 787 9537, option 2, from 8:00 AM to 7:00 PM (Eastern Time), Monday Friday, or HeartSine Technologies Technical Support at heartsinesupport@stryker.com.", "product_quantity": "1,291,165 units", "distribution_pattern": "US Nationwide distribution. Worldwide distribution to Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Latvia, Lithuania, Malaysia, Malta, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom.", "openfda": { "k_number": [ "K102496", "K010214", "K011901", "K130684", "K000638", "K110742", "K003565", "K984582", "K896919", "K002232", "K150055", "K990106", "K131550", "K973486", "K133659", "K051632", "K883341", "K020984", "K041883", "K932028", "K991007", "K052316", "K870622", "K103186", "K991910", "K955854", "K965117", "K934692", "K020743", "K010207", "K980857", "K131525", 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