{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "217188", "product_res_number": "Z-0593-2026", "event_date_initiated": "2025-11-10", "event_date_posted": "2025-12-08", "recall_status": "Open, Classified", "res_event_number": "97923", "product_code": "BZA", "product_description": "ErgoStar CM 60, \nModel/Catalog Number: MP01860, \n \nAirway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mechanically ventilated patient.", "code_info": "Model/Catalog Number: MP01860;\nUDI Number: 04048675420699;\nLot numbers: All lot numbers;", "firm_fei_number": "2517967", "recalling_firm": "Draeger, Inc.", "address_1": "3135 Quarry Rd", "city": "Telford", "state": "PA", "postal_code": "18969-1042", "additional_info_contact": "Michael Kelhart\n01-267-6641131", "reason_for_recall": "Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.", "root_cause_description": "Under Investigation by firm", "action": "On November 10, 2025, Urgent Medical Device Recall letters were sent to customers. Necessary Action: Identify if you have any affected product. Do not use any unused ErgoStar CM 40/CM 45/CM 55/CM 60 in your stock. Unused stock should be removed and returned to Draeger. Draeger recommends the alternative product MP01850 ErgoStar CM 50 as a suitable replacement. Please ensure that all potential users in your facility are made aware of this Urgent Medical Device Recall Notice and the information contained herein. If you have forwarded affected products to third parties, please also forward this Urgent Medical Device Recall notification.", "product_quantity": "2050 units", "distribution_pattern": "Worldwide distribution. US states of CA, FL, IL, NY, OH, OK, PA, SC, TX, and WI; Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czech Republic, Ecuador, Finland, France, Germany, Hungary, Indonesia, Italy, Japan, Mexico, Netherlands, Norway, Pakistan, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovakia, South Africa, South Korea, Spain, Switzerland, Thailand, Turkiye, Ukraine, and United Kingdom.", "openfda": { "k_number": [ "K860885", "K921511", "K860352", "K802663", "K791539", "K770585", "K884374", "K790887", "K921512", "K944535", "K880434", "K810361", "K813383", "K791532", "K913726", "K781759", "K882203", "K860887", "K940793", "K812977", "K873974", "K944534", "K931800", "K895144", "K952824", "K770587", "K860838", "K931038", "K881230", "K944532", "K894969", "K895388", "K861056", "K925263", "K850625", "K924225", "K844656", "K871737", "K895549", "K811922", "K781395", "K860878", "K954197", "K770052", "K911425", "K922537", "K931345", "K940544", "K862435", "K840015", 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"device_name": "Connector, Airway (Extension)", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5810", "device_class": "1" } } ] }