{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "215325", "product_res_number": "Z-2460-2025", "event_date_initiated": "2025-07-14", "event_date_posted": "2025-08-28", "recall_status": "Open, Classified", "res_event_number": "97357", "product_code": "NLH", "k_numbers": [ "K241156" ], "product_description": "Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic Electrophysiology Catheter Models\n401150RH, 401206RH, 401207RH, 401210RH, 401211RH, 401212RH, 401222RH, 401223RH, 401226RH, 401227RH, 401228RH, 401260RH, 401261RH, 401271RH, 401305RH, 401306RH, 401309RH, 401310RH, 401311RH, 401312RH, 401317RH, 401353RH, 401357RH, 401381RH, 401392RH, 401399RH, 401400RH, 401425RH, 401430RH, 401433RH, 401434RH, 401435RH, 401436RH, 401438RH, 401441RH, 401442RH, 401445RH, 401443RH, 401444RH, 401448RH, 401449RH, 401450RH, 401451RH, 401453RH, 401466RH, 401468RH, 401474RH, 401475RH, 401859RH, 401860RH, 401863RH, 401864RH, 401865RH, 401876RH, 401877RH, 401878RH, 401890RH, 401891RH, 401892RH, 401893RH, 401966RH, 401967RH, 401979RH, 401994RH, 401996RH, 402004RH, 402008RH, 402009RH, 402010RH, 402011RH, 402012RH", "code_info": "1) 401211RH, UDI-DI: 10197344043736(each), 10197344043736(case), Lot Number: EP250106;\n2) 401222RH, UDI-DI: 10197344043712(each), 10197344043712(case), Lot Number: EP241118;\n3) 401222RH, UDI-DI: 10197344043712(each), 10197344043712(case), Lot Number: EP250106;\n4) 401223RH, UDI-DI: 10197344043705(each), 10197344043705(case), Lot Number: EP250106;\n5) 401226RH, UDI-DI: 10197344043699(each), 10197344043699(case), Lot Number: EP241118;\n6) 401226RH, UDI-DI: 10197344043699(each), 10197344043699(case), Lot Number: EP250106;\n7) 401227RH, UDI-DI: 10197344043682(each), 10197344043682(case), Lot Number: EP250106;\n8) 401260RH, UDI-DI: 10197344043668(each), 10197344043668(case), Lot Number: EP241118;\n9) 401260RH, UDI-DI: 10197344043668(each), 10197344043668(case), Lot Number: EP250106;\n10) 401261RH, UDI-DI: 10197344043651(each), 10197344043651(case), Lot Number: EP250106;\n11) 401305RH, UDI-DI: 10197344043637(each), 10197344043637(case), Lot Number: EP250106;\n12) 401309RH, UDI-DI: 10197344043613(each), 10197344043613(case), Lot Number: EP250106;\n13) 401353RH, UDI-DI: 10197344043569(each), 10197344043569(case), Lot Number: EP241118;\n14) 401353RH, UDI-DI: 10197344043569(each), 10197344043569(case), Lot Number: EP250106;\n15) 401381RH, UDI-DI: 10197344043545(each), 10197344043545(case), Lot Number: EP241118;\n16) 401381RH, UDI-DI: 10197344043545(each), 10197344043545(case), Lot Number: EP250106;\n17) 401399RH, UDI-DI: 10197344043521(each), 10197344043521(case), Lot Number: EP241118;\n18) 401399RH, UDI-DI: 10197344043521(each), 10197344043521(case), Lot Number: EP250106;\n19) 401430RH, UDI-DI: 10197344043491(each), 10197344043491(case), Lot Number: EP241118;\n20) 401430RH, UDI-DI: 10197344043491(each), 10197344043491(case), Lot Number: EP250106;\n21) 401433RH, UDI-DI: 10197344043484(each), 10197344043484(case), Lot Number: EP241118;\n22) 401434RH, UDI-DI: 10197344043477(each), 10197344043477(case), Lot Number: EP241118;\n23) 401435RH, UDI-DI: 10197344043460(each), 10197344043460(case), Lot Number: EP241118;\n24) 401436RH, UDI-DI: 10197344043453(each), 10197344043453(case), Lot Number: EP250106;\n25) 401441RH, UDI-DI: 10197344043439(each), 10197344043439(case), Lot Number: EP241118;\n26) 401441RH, UDI-DI: 10197344043439(each), 10197344043439(case), Lot Number: EP250106;\n27) 401442RH, UDI-DI: 10197344044245(each), 10197344044245(case), Lot Number: EP241118;\n28) 401442RH, UDI-DI: 10197344044245(each), 10197344044245(case), Lot Number: EP250106;\n29) 401443RH, UDI-DI: 10197344044252(each), 10197344044252(case), Lot Number: EP241118;\n30) 401443RH, UDI-DI: 10197344044252(each), 10197344044252(case), Lot Number: EP250106;\n31) 401444RH, UDI-DI: 10197344044269(each), 10197344044269(case), Lot Number: EP241118;\n32) 401444RH, UDI-DI: 10197344044269(each), 10197344044269(case), Lot Number: EP250106;\n33) 401448RH, UDI-DI: 10197344044283(each), 10197344044283(case), Lot Number: EP250106;\n34) 401449RH, UDI-DI: 10197344044290(each), 10197344044290(case), Lot Number: EP241118;\n35) 401449RH, UDI-DI: 10197344044290(each), 10197344044290(case), Lot Number: EP250106;\n36) 401450RH, UDI-DI: 10197344044306(each), 10197344044306(case), Lot Number: EP241118;\n37) 401450RH, UDI-DI: 10197344044306(each), 10197344044306(case), Lot Number: EP250106;\n38) 401451RH, UDI-DI: 10197344044313(each), 10197344044313(case), Lot Number: EP241118;\n39) 401451RH, UDI-DI: 10197344044313(each), 10197344044313(case), Lot Number: EP250106;\n40) 401453RH, UDI-DI: 10197344044320(each), 10197344044320(case), Lot Number: EP250106;\n41) 401474RH, UDI-DI: 10197344044351(each), 10197344044351(case), Lot Number: EP241118;\n42) 401474RH, UDI-DI: 10197344044351(each), 10197344044351(case), Lot Number: EP250106;\n43) 401860RH, UDI-DI: 10197344044382(each), 10197344044382(case), Lot Number: EP241118;\n44) 401860RH, UDI-DI: 10197344044382(each), 10197344044382(case), Lot Number: EP250106;\n45) 401863RH, UDI-DI: 10197344044399(each), 10197344044399(case), Lot Number: EP241118;\n46) 401863RH, UDI-DI: 10197344044399(each), 10197344044399(case), Lot Number: EP250106;\n47) 401864RH, UDI-DI: 10197344044405(each), 10197344044405(case), Lot Number: EP241118;\n48) 401864RH, UDI-DI: 10197344044405(each), 10197344044405(case), Lot Number: EP250106;\n49) 401877RH, UDI-DI: 10197344044436(each), 10197344044436(case), Lot Number: EP241118;\n50) 401878RH, UDI-DI: 10197344044443(each), 10197344044443(case), Lot Number: EP241118;\n51) 401890RH, UDI-DI: 10197344044450(each), 10197344044450(case), Lot Number: EP241118;\n52) 401890RH, UDI-DI: 10197344044450(each), 10197344044450(case), Lot Number: EP250106;\n53) 401891RH, UDI-DI: 10197344044467(each), 10197344044467(case), Lot Number: EP241118;\n54) 401966RH, UDI-DI: 10197344044498(each), 10197344044498(case), Lot Number: EP250106;\n55) 402004RH, UDI-DI: 10197344044566(each), 10197344044566(case), Lot Number: EP241118;\n56) 402004RH, UDI-DI: 10197344044566(each), 10197344044566(case), Lot Number: EP250106;\n57) 402008RH, UDI-DI: 10197344044573(each), 10197344044573(case), Lot Number: EP241118;\n58) 402010RH, UDI-DI: 10197344044597(each), 10197344044597(case), Lot Number: EP241118;\n59) 402010RH, UDI-DI: 10197344044597(each), 10197344044597(case), Lot Number: EP250106;\n60) 402012RH, UDI-DI: 10197344043835(each), 10197344043835(case), Lot Number: EP241118;\n61) 402012RH, UDI-DI: 10197344043835(each), 10197344043835(case), Lot Number: EP250106", "firm_fei_number": "1417592", "recalling_firm": "MEDLINE INDUSTRIES, LP - Northfield", "address_1": "3 Lakes Dr", "city": "Northfield", "state": "IL", "postal_code": "60093-2753", "additional_info_contact": "Haley Barclay\n866-359-1704", "reason_for_recall": "Specific lots of reprocessed electrophysiology catheters may contain small residual particulates.", "root_cause_description": "Under Investigation by firm", "action": "An Urgent Medical Device Recall notification letter dated 7/14/25 was sent to customers.\n\nREQUIRED ACTION:\n1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed on the enclosed response form. Quarantine all affected product immediately.\n2. Please complete and return the enclosed response form via email to: recalls@medline.com or fax: 866-767-1290, listing the quantity of affected product you have in inventory. Even if you do not have any affected product in inventory, please complete and return the response form.\n3. Upon receipt of your submitted response form, return labels and RGA information will be provided, if applicable. Your account will receive credit when the returned product is received.\n4. If you are a distributor or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please request your customers return any affected product to you for collection and return to Medline Industries, LP.\n\nIf you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.", "product_quantity": "398 units", "distribution_pattern": "US Nationwide.", "openfda": { "k_number": [ "K162251", "K160421", "K181618", "K160496", "K160303", "K012523", "K211276", "K081329", "K092158", "K161464", "K153153", "K161827", "K051220", "K171788", "K250772", "K221854", "K012688", "K242225", "K040751", "K200205", "K043513", "K203655", "K252405", "K030114", "K012678", "K161393", "K030279", "K170922", "K030026", "K100254", "K182488", "K101789", "K082023", "K171503", "K193263", "K221067", "K042074", "K181458", "K030109", "K121158", "K161272", "K150357", "K160242", "K061045", "K050763", "K181897", "K233825", "K090323", "K180710", "K240972", "K241156", "K012708", "K023180", "K052603", "K241224", "K043393", "K030187", "K240826", "K022316", "K112292", "K190127", "K181056", "K153006", "K151617", "K051043", "K112232", "K191170", "K052414", "K043392", "K012687" ], "registration_number": [ "3009888344", "2032112", "1319639", "3011610434", "3011276773", "3009350690", "2011171", "2090040", "3011024991", "2183744", "3032391" ], "fei_number": [ "3002615969", "3009888344", "1000138054", "3011610434", "3011276773", "3002299608", "3009350690", "2011171", "2183744", "3011024991", "3003076831" ], "device_name": "Catheter, Recording, Electrode, Reprocessed", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.1220", "device_class": "2" } } ] }