{ "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": 10 } }, "results": [ { "cfres_id": "216910", "product_res_number": "Z-0442-2026", "event_date_initiated": "2025-10-10", "event_date_posted": "2025-11-13", "recall_status": "Open, Classified", "res_event_number": "97882", "product_code": "CAI", "product_description": "Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits;\n\nProduct description/Product numbers:\n\nADULT 120 EXPANDABLE W/MASK\nDYNJAA10591;\nANES CIRC 120IN EXP-LF\nDYNJAA6555G;\nANES CIRCUIT ADULT 120\"-LF\nDYNJAA10817;\nANESTHESIA 120\" ADLT-LF\nDYNJAA10775;\nANESTHESIA CIRC ADULT 120-LF\nDYNJAA10601;\nANESTHESIA CIRCUIT - LF\nDYNJAA10261B;\nANESTHESIA CIRCUIT 120EXP-LF\nDYNJAA10741A;\nANESTHESIA CIRCUIT ADULT-LF\nDYNJAA0380A\nDYNJAA10641\nDYNJAA10706B\nDYNJAA10851\nDYNJAA10922B\nDYNJAA10971A\nDYNJAA11030A\nDYNJAA11087\nDYNJAA11126;\nANESTHESIA CIRCUIT-LF\nDYNJAA0309A\nDYNJAA0368A\nDYNJAA10368A\nDYNJAA10392\nDYNJAA10430A\nDYNJAA10547A\nDYNJAA10639A\nDYNJAA10656A\nDYNJAA10685A\nDYNJAA10685B;\nCIRC 120\" EXP 1 BV HMEF 3L GSL\nDYNJAA10920;\nEXPANDABLE CIRCUIT-LF\nDYNJAA11095;\nNM ANESTHESIA TURNOVER KIT\nDYNJAA0433;\nPROV HEALTH HEPA CIRC #2-LF\nDYNJAA0360;\nSPTMPX01IA CIRCUIT ADULT-LF\nDYNJAA10973A;", "code_info": "DYNJAA0309A\nUDI-DI 40193489400268 (case), 10193489400267 (ea)\nLots\n25EBU353\n25GBI473;\n\nDYNJAA0360\nUDI DI 40193489419000 (case), 10193489419009 (ea)\nLots\n25EBU304\n25GBQ732;\n\nDYNJAA0368A\nUDI-DI 40195327092550 (case), 10195327092559 (ea)\nLots\n25GBH582;\n\nDYNJAA0380A\nUDI-DI 40195327478286 (case), 10195327478285 (ea)\nLots\n25FBB950\n25FBT875\n25GBX623;\n\nDYNJAA0433\nUDI-DI 40198459320706 (case), 10198459320705 (ea)\nLots\n25EBH621\n25EBQ391;\n\nDYNJAA10261B\nUDI- DI 40193489430784 (case), 10193489430783 (ea)\nLots\n25FBJ760;\n\nDYNJAA10368A\nUDI-DI 40198459320720 (case), 10198459320729 (ea)\nLots\n25GBY374\n25IBK072;\n\nDYNJAA10392\nUDI-DI 40888277962201 (case), 10888277962200 (ea)\nLots\n25FBN032;\n\nDYNJAA10430A\nUDI-DI 40193489832052 (case), 10193489832051 (ea)\nLots\n25FBW335\n25IBH048;\n\nDYNJAA10547A\nUDI-DI 40193489603188 (case), 10193489603187 (ea)\n25FBT853;\n\nDYNJAA10591\nUDI-DI 40889942632535 (case), 10889942632534 (ea)\nLots\n25FBD876\n25FBD877\n25GBJ254\n25GBJ256;\n\nDYNJAA10601\nUDI-DI 40889942655435 (case), 10889942655434 (ea)\nLots\n25FBN184\n25HBM893;\n\nDYNJAA10639A\nUDI-DI 40888277761958 (case), 10888277761957 (ea)\nLots\n25FBN043;\n\nDYNJAA10641\nUDI-DI 40889942841227 (case), 10889942841226 (ea)\nLots\n25EBK360;\n\nDYNJAA10656A\nUDI-DI 40193489455527 (case), 10193489455526 (ea)\nLots\n25FBN055;\n\nDYNJAA10685A\nUDI-DI 40195327279142 (case), 10195327279141 (ea)\nLots\n25EBJ456;\n\nDYNJAA10685B\nUDI-DI 40198459372293 (case), 10198459372292 (ea)\nLots\n25FBL121\n25FBT898\n25FBT899;\n\nDYNJAA10706B\nUDI-DI 40193489485982 (case), 10193489485981 (ea)\nLots\n25FBH921\n25GBK879\n25GBN124\n25GBN125;\n\nDYNJAA10741A\nUDI-DI 40193489250573 (case), 10193489250572 (ea)\nLots\n25EBK364\n25FBQ326\n25HBA472;\n\nDYNJAA10775\nUDI-DI 40193489348102 (case), 10193489348101 (ea)\nLots\n25GBY311\n25IBD803;\n\nDYNJAA10817\nUDI-DI 40193489365338 (case), 10193489365337 (ea)\nLots\n25GBO619;\n\nDYNJAA10851\nUDI-DI 40193489429467 (case), 10193489429466 (ea)\nLots\n25GBE789\n25IBL075;\n\nDYNJAA10920\nUDI-DI 40193489463386 (case), 10193489463385 (ea)\nLots\n25FBT844\n25GBP694;\n\nDYNJAA10922B\nUDI-DI 40198459301880 (case), 10198459301889 (ea)\nLots\n25FBQ442\n25GBO675;\n\nDYNJAA10971A\nUDI-DI 40195327298167 (case), 10195327298166 (ea)\nLots\n25GBA751;\n\nDYNJAA10973A\nUDI-DI 40195327372423 (case), 10195327372422 (ea)\nLots\n25FBQ349;\n\nDYNJAA11030A\nUDI-DI 40195327341030 (case), 10195327341039 (ea)\nLots\n25FBQ346;\n\nDYNJAA11087\nUDI-DI 40195327694402 (case), 10195327694401 (ea)\nLots\n25FBG942\n25FBG944;\n\nDYNJAA11095\nUDI-DI 40195327520992 (case), 10195327520991 (ea)\nLots\n25GBY361;\n\nDYNJAA11126\nUDI-DI 40195327695508 (case), 10195327695507 (ea)\nLots\n25EBV629\n25GBL211;\n\nDYNJAA6555G\nUDI-DI 40195327214648 (case), 10195327214647 (ea)\nLots\n25EBG518\n25FBS747\n25FBS748\n25HBE691", "firm_fei_number": "1417592", "recalling_firm": "Medline Industries, LP", "address_1": "3 Lakes Dr", "city": "Northfield", "state": "IL", "postal_code": "60093-2753", "additional_info_contact": "Haley Barclay\n866-359-1704", "reason_for_recall": "Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120\" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment.", "root_cause_description": "Nonconforming Material/Component", "action": "Safety notice was provided to customers on 10/10/2025. Follow-up \"URGENT MEDICAL DEVICE RECALL\" notification dated 10/21/2025 was sent out on 10/21/2025. Notification was through email and first-class mail.\n\nCustomers were instructed to Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product and destroy affected kits on hand. No products are to be returned to Medline.\n\nPlease use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the response form.\nWebsite link: https://recalls.medline.com\nRecall Reference #: R-25-215-FG\nRecall Code: \n\nIf 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 that customers destroy any affected product. You should include your customers quantities on your response form.\n\nAn expanded \"URGENT MEDICAL DEVICE RECALL\" notification dated 10/24/2025 was provided to customers on 10/24/25, which included additional affected products.\n\nIf you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.", "product_quantity": "96,406 total units", "distribution_pattern": "International distribution to Mexico and Panama. 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"3008693658", "1000283452", "3014916466", "3005767446", "3011986317", "3043619925", "3003040625", "3006897996", "1832562", "3006061749", "3013576541", "3005543241", "3010400865", "3004050971", "3014342096", "3010439239", "3012834717", "3007092328", "3005273623", "3010834934", "3045816902", "3002807391", "1000604079", "3000210616", "3004365956", "3006547005", "3008258694", "3002806783", "3006210673", "3006363476", "3013530405", "3015168843", "2020550", "3013783488", "3018762668", "3038195661", "3015907115", "3010402691", "3004122598", "3006446479", "3012494290", "3016458361", "3044994756", "3011987967", "3013187142", "3006157842", "3010957755", "3008806809", "3013557562", "3044320625", "3005347827", "3001415205", "3003256355", "3002806988" ], "device_name": "Circuit, Breathing (W Connector, Adaptor, Y Piece)", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5240", "device_class": "1" } } ] }