{ "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": 4 } }, "results": [ { "cfres_id": "214237", "product_res_number": "Z-2158-2025", "event_date_initiated": "2025-06-16", "event_date_posted": "2025-07-31", "recall_status": "Open, Classified", "res_event_number": "97026", "product_code": "CAH", "k_numbers": [ "K221836" ], "product_description": "SafeStar 90 Plus Filter. Bidirectionally breathing system filter.", "code_info": "Model No. MP05785; UDI: 04048675665762; All Lots.", "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": "Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.", "root_cause_description": "Process control", "action": "An initial Urgent Medical Device Recall notification dated June 2025 was mailed to consignees. The notification instructs consignees to not make therapeutic decisions based solely on individual measured values or parameters, regardless of the measuring point and the ventilator or anesthesia machine used. Consignees are to not connect the sample line to the filter sampling port; if an alternative sample port is not feasible, the firm requests that consignees use an alternative filter. All users of affected devices are to be notified of this recall notice and the notice forwarded to customers to which product was further distributed. Consignees are asked to complete and return the provided Response Acknowledgement and Receipt Form. Questions can be directed to Michael Kelhart at 267-664-1131 from 8:00 AM EST to 4:30 PM EST, or by email at mike.kelhart@draeger.com. \nA second Urgent Medical Device Recall notification dated July 2025 was mailed to consignees. This notification recommends that any unused filters affected by this recall not be used and any unused stock should be removed. Consignees are to contact their local Draeger Representative for information regarding alternatives. Draeger Customer Success can be contacted at 1-800-437-2437 (option 2, option 1) or US-Medical@draeger.com to coordinate return/replacement. This recall notification should be shared with all users and forwarded to where devices were further distributed.", "product_quantity": "669,838 units", "distribution_pattern": "Worldwide - US Nationwide distribution including in the states of AK, AZ, CA, CO, CT, FL, ID, IL, IN, KAS, LA, MA, ME, MI, MN, MO, NC, NE, NM, NV, NY, OH, PA, SD, TN, TX, UT, WA, WI, WY and the countries of Angola, Argentina, Australia, Austria, Belarus, Belgium, Bolivia, Bosnia-Herz., Brazil, Bulgaria, Burkina-Faso, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Rep., El Salvador, Faeroe, France, French Guiana, Gabon, Germany, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Ivory Coast, Japan, Jordan, Kosovo, Kuwait, Latvia, Lebanon, Libya, Liechtenstein, Malaysia, Mali, Mexico, Moldavia, Mongolia, Morocco, Netherlands, New Zealand, Nigeria, North Macedonia, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad, Tobago, Turkey, Ukraine, United Kingdom, United Arab Emirates, Uzbekistan, Vietnam.", "openfda": { "k_number": [ "K190022", "K032716", "K934132", "K945543", "K851070", "K954490", "K760567", "K132709", "K912577", "K952015", "K965016", "K770376", "K801803", "K221472", "K110246", "K011212", "K222917", "K772047", "K925462", "K934189", "K922492", "K862786", "K182862", "K013122", "K830618", "K781696", "K980662", "K812075", "K941536", "K021020", "K880958", "K952428", "K043148", "K925388", "K111408", "K896832", "K900990", "K890346", "K883693", "K923661", "K931217", "K896116", "K221250", "K000654", "K230483", "K890035", "K002201", "K092218", "K211286", "K892520", "K210352", "K791307", "K964204", "K951484", "K911651", "K790896", "K951047", "K983817", "K844492", "K091363", "K252643", "K893030", "K821310", "K842580", "K862790", "K101629", "K880681", 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