{ "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": "2026-04-01", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "status": "Terminated", "city": "Bloomington", "state": "IN", "country": "United States", "classification": "Class II", "openfda": {}, "product_type": "Devices", "event_id": "86965", "recalling_firm": "Cook Medical Llc", "address_1": "1025 W Acuff Rd", "address_2": "N/A", "postal_code": "47404-9295", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Letter", "distribution_pattern": "US Nationwide", "recall_number": "Z-0809-2021", "product_description": "Disposable Humidification Flask, Reference Part Number K-MINC-CTS-S, Order Number G32707", "product_quantity": "56250", "reason_for_recall": "A small percentage of the Disposable Humidification Flasks may have a manufacturing defect that can cause the silicone stoppers to dislodge or gas to leak from the flasks, impeding gas flow to the incubation chambers of the Mini Incubator.", "recall_initiation_date": "20201216", "center_classification_date": "20210108", "termination_date": "20231108", "report_date": "20210120", "code_info": "Lot Numbers: A1007159 A1007162 A1007163 A1007164 A1007160 A1007161 A1007406 A1007409 A1007405 A1007407 A1007408 A1007410 A1007662 A1007663 A1007661 A1007660 A1007838 A1007837 AC1007995 A1008104 A1008105 A1008110 A1008252 A1008253 A1008255 A1008254 A1008484 A1008485 A1008483 A1008491 A1008675 A1008677 A1008673 A1008674 A1008676 A1008709 A1008710 A1008714 A1008715 A1008942 A1008943 A1008946 A1008945 A1008944 A1008947 A1009066 A1009067 A1009271 A1009274 A1009275 A1009272 A1009273 A1009477 A1009478 A1009479 A1009548 A1009549 AC1009536 A1009480 A1009674 A1009675 A1010176 A1010177 A1010232 A1010234 A1010237 A1010235 A1010233 A1010236 A1010596 A1010597 A1010594 A1010595 A1010598 A1011063 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