{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "218655", "product_res_number": "Z-2161-2026", "event_date_initiated": "2026-04-13", "event_date_posted": "2026-05-11", "recall_status": "Open, Classified", "res_event_number": "98417", "product_code": "DRM", "k_numbers": [ "K090422", "K161768" ], "product_description": "LUCAS 2\nModel Number: 99576\nCatalog Numbers: 99576-000024 and 99576-000011\nUDI-DI code: 00883873904565\n\nLUCAS 3\nModel Number: 99576\nCatalog Number: 99576-000043\nUDI-DI code: 00883873861875\n\nLUCAS 3.1\nModel Number: 99576\nCatalog Number: 99576-000063\nUDI-DI code: 00883873834329\n\nLUCAS chest compression System is to be used for performing external cardiac compressions on adult patients who have acute circulatory arrest defined as absence of spontaneous breathing and pulse, and loss of consciousness.", "code_info": "LUCAS 2\nModel Number: 99576\nCatalog Numbers: 99576-000024 and 99576-000011\nUDI-DI code: 00883873904565\nSerial Numbers:\n30100846\n30112125\n30123845\n30124348\n30124440\n30124475\n30124991\n30136605\n30148155\n30148365\n3015B568\n3015B682\n3015C276\n3015C722\n3015C723\n3015C724\n3015F246\n3015F587\n3016G845\n3016H983\n3017K078\n3017K079\n3017K080\n\nLUCAS 3\nModel Number: 99576\nCatalog Number: 99576-000043\nUDI-DI code: 00883873861875\nSerial Numbers:\n35160778\n35173272\n35173461\n35185820\n35185817\n35175040\n35175039\n35173347\n35160921\n35175373\n35174279\n35172701\n35161449\n\nLUCAS 3.1\nModel Number: 99576\nCatalog Number: 99576-000063\nUDI-DI code: 00883873834329\nSerial Numbers:\n3520R763\n3522AN95\n3519F615\n3520N419\n3522DK48\n3521S574\n3521T901\n3520R187\n3518B300\n3522EG06\n3520P749\n3520R206\n3520S005\n3520P512\n3520P691\n3520P741\n3520P742\n3520P744\n3520P745\n3520P746\n3520P748\n3520P810\n3520S006\n3520P747\n3520S003\n3521AF21\n3518B131\n3520L408\n3519E743\n3521AC18\n3521U379\n3520O364\n3520S292\n3519F035\n3520S149\n3521Z495\n3521Z496\n3520P082\n3520L957\n3520R180\n3519G235\n3519G633\n3519H568\n3519E607\n3522BI32\n3518D028\n3522CN47\n3520K867\n3519I425\n3520K923\n3523FA45\n3520O771\n3520R123\n3521W020\n3520K966\n3522AV78\n3521T568\n3520O776\n3518A707\n3521T325\n3521T329\n3518C485\n3518D396\n3522BU41\n3519G180\n3522AR04\n3522AR05\n3520R135\n3522CR96\n3523EN71\n3520R209\n3520L915\n3520L916\n3520N979\n3520O026\n3520O298\n3520P109\n3520P559\n3520S287\n3521V691\n3522AR01\n3522AR03\n3518D017\n3519E728\n3520N729\n3519F039\n3520L676\n3520N364\n3520N366\n3521S486\n3520P539\n3521V200\n3522BZ70\n3523FL02\n3523FL03\n3521T704\n3521T575\n3520O549\n3520P906\n3520P928\n3520P930\n3522AR07\n3520R138\n3523EN74\n3521V688\n3519F034\n3523FA47\n3520P907\n3520S285\n3521S487\n3522AR00\n3522AR06\n3523FD33\n3519F038\n3523FH21\n3520N010\n3520N505", "firm_fei_number": "3005445717", "recalling_firm": "Jolife AB", "address_1": "Scheelevagen 17 17 ideon science park scheelevagen", "city": "Lund", "country": "Sweden", "additional_info_contact": "Joyce Staggs\n425-867-5497", "reason_for_recall": "Due to a subset of chest compression systems/devices where the service performed on the systems were not appropriately documented (The documents for the service performed to justify the passing results were not include in the service records).", "root_cause_description": "Under Investigation by firm", "action": "On 04/13/2026, the firm sent via US Postal an \"Urgent: Medical device correction\" letter informing customers that through complaint reviews, Stryker discovered a subset of work orders performed between July 2023 through November 2025 with Performance Inspection Procedures (PIP) recorded as PASS without the corresponding objective evidence properly documented in the work orders.\n\nCustomers are instructed to:\n1. Immediately check internal inventory to locate the affected product as listed.\n2. Return the business reply form by email to RSRecall@Stryker.com to confirm receipt of this notification.\n3. Upon receipt of the completed business reply form, Stryker will contact customers to arrange for corrective action on the device if service has not been performed.\n4. There are no additional actions that users can and should take. Continue to follow the Operating Instructions and perform the daily checks and user tests. These tests can be found in the chapter Maintaining the Equipment subsection General Maintenance and Testing .\n5. 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.\n6. Inform Stryker if any of the subject devices have been distributed to other organizations. If so, provide contact details, so Stryker can inform the recipients appropriately.\n\nAny questions or concerns, contact Customer Service +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": "153 systems", "distribution_pattern": "U.S. Nationwide distribution in the states of AL, AZ, CA, FL, HI, IA, KS, KY, LA, MA, MD, MN, NC, NV, OH, SC, TX, UT, VA, WA, and WY.", "openfda": { "k_number": [ "K854734", "K851139", "K791145", "K053403", "K161768", "K024215", "K922093", "K072527", "K011046", "K062119", "K153628", "K792454", "K790513", "K811909", "K841410", "K855004", "K032852", "K951124", "K063602", "K211289", "K792451", "K173553", "K090422", "K022345", "K841275", "K841822", "K040453", "K871272", "K833879", "K801947", "K102068", "K962237", "K801946", "K811987", "K972525", "K062401", "K141809", "K792452", "K871271", "K792458", "K801945", "K073079", "K221700", "K761194", "K112998" ], "registration_number": [ "3005445717", "3008727520", "3026976873", "3013964848", "3007275459", "3015876", "3010617000", "3003521780", "3029871637", "1821850", "3010030355", "3010703925", "3012972516" ], "fei_number": [ "3005445717", "3008727520", "3026976873", "3003793491", "3013964848", "3007275459", "3015876", "3003521780", "3029871637", "1821850", "3010030355", "3010703925", "3012972516" ], "device_name": "Compressor, Cardiac, External", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.5200", "device_class": "2" } } ] }