{ "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": "220075", "product_res_number": "Z-2296-2026", "event_date_initiated": "2026-04-24", "event_date_posted": "2026-06-03", "recall_status": "Open, Classified", "res_event_number": "98881", "product_code": "DXT", "k_numbers": [ "K050456" ], "product_description": "Avanta Multi-Patient Administration Tube Sets (AVA 500 MPAT (Part 2 of 2)) used with the Medrad Avanta Injection System;\nCatalog number: AVA 500 MPAT (Part 2 of 2);\nAffected material numbers: 87629007, 60729458, 86566648;", "code_info": "Catalog number: AVA 500 MPAT (Part 2 of 2)\nAffected material numbers: 87629007, 60729458, 86566648;\nAffected batch numbers: 251702, 252302, 252502, 252602, 252702, 252802, 253304, 253702, 253704, 253804, 254202, 254304, 254704, 254802;", "firm_fei_number": "2520313", "recalling_firm": "Bayer Medical Care, Inc.", "address_1": "1 Bayer Dr", "city": "Indianola", "state": "PA", "postal_code": "15051-9702", "additional_info_contact": "Lindsay Metkler\n412-406-2153", "reason_for_recall": "Supplier changes resulted in a fit issue with the Contrast Flow Control Valve (CFCV) interface on the Avanta Injector System. Multiple customer reports indicate that the stopcock cannot be reliably engaged with the CFCV snap interface. In instances where engagement is achieved through applied force, the connection is unstable, and the stopcock may disengage before or during contrast injection, leading to procedure interruption.", "root_cause_description": "Process control", "action": "On April 24, 2026, URGENT MEDICAL DEVICE RECALL letters were sent to customers. Customers were instructed to immediately halt the use of the affected product and review inventory for impacted product and quarantine. A Return Goods Authorization will be sent to return any remaining affected inventory. Place the affected product in a box and label the outside of the container with the RGA number provided and RECALL ID: SA-2026-RAD-03 in large, bold writing. Use the shipping label provided via email when you receive your RGA number. Please return the affected product as soon as possible. Please distribute this letter to other appropriate departments and personnel within your facility who may need awareness of this recall.", "product_quantity": "11,300 units (1650 US, 9650 OUS)", "distribution_pattern": "Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DE, FL, IA, IL, IN, KS, KY, LA, MA, MD, ME, MO, NC, NY, OH, OK, PA, SC, TN, TX, VA, WI and the countries of AE, BA, BE, CA, CH, CN, DE, DK, ES, FR, GB, HK, HR, IL, KW, MT, MX, NL, RO, RU, SE, ZA.", "openfda": { "k_number": [ "K883452", "K962141", "K910873", "K924116", "K172694", "K042744", "K830754", "K991103", "K944875", "K061976", "K203004", "K830609", "K854310", "K161471", "K071691", "K031339", "K211564", "K833138", "K873687", "K253048", "K823340", "K162088", "K082212", "K904994", "K973230", "K190102", "K872472", "K192370", "K791782", "K090621", "K860204", "K890292", "K133600", "K152978", "K171646", "K182273", "K113133", "K023183", "K241109", "K951802", "K153141", "K152218", 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