{ "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": "2026-10-08", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "211660", "product_res_number": "Z-0821-2025", "event_date_initiated": "2024-12-10", "event_date_posted": "2025-01-10", "recall_status": "Open, Classified", "res_event_number": "95967", "product_code": "BTL", "k_numbers": [ "K093913" ], "product_description": "Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Part: 1050805, 1050808, 1050809, 1050810, 1050811, 1050814, 1050832, 1050839, 1050840, 1050841, 1050842", "code_info": "Part/UDI-DI/Lot:\n1050805/10641043508053, 30641043508057/2421450805, 2423550805, 2423650805, 2426750805;\n1050808/10641043508084, 30641043508088/2426450808, 2426750808, 2426850808, 2429050808, 2429350808;\n1050809/10641043508091, 30641043508095/2426450809, 2426750809, 2429050809, 2429150809, 2429350809, 2429750809, 2429850809, 2430050809, 2430250809;\n1050810 /10641043508107, 30641043508101/2426750810, 2429350810, 2429750810, 2429850810, 2430250810;\n1050811/10641043508114, 30641043508118/2426550811, 2426650811, 2426750811, 2429050811, 2429150811, 2429250811, 2429350811, 2429450811, 2429750811, 2429850811, 2429950811, 2430250811;\n1050814/10641043508145, 30641043508149/2426450814, 2426750814, 2429050814, 2429750814, 2430250814;\n1050832/10641043508329, 30641043508323/2429050832, 242985083;\n1050839/10641043508398, 30641043508392/2430350839;\n1050840/10641043508404, 30641043508408/2429050840, 2429750840;\n1050841/10641043508411, 30641043508415/2429050841;\n1050842/10641043508428, 30641043508422/2426750842", "firm_fei_number": "1024404", "recalling_firm": "Mercury Enterprises, Inc. dba Mercury Medical", "address_1": "11300 49th St N", "city": "Clearwater", "state": "FL", "postal_code": "33762-4807", "additional_info_contact": "727-573-0088", "reason_for_recall": "Gas powered emergency resuscitator has a circuit flow controller manufactured with an undersized spring, which may cause resuscitator not reach the high and low ends of the PIP and PEEP pressure ranges, which may cause a loss of positive pressure, impacting effective ventilation of the patient.", "root_cause_description": "Process change control", "action": "On 12/10/2024, \"URGENT: FIELD SAFETY NOTICE\" letters were mailed and emailed to medical facilities and distributors who were asked to do the following:\n\nMedical Facilities/Distributors:\n1) Users should cease use and distribution of affected product and immediately quarantine the affected product. \n2) Contact firm's customer service department at uscustomerservice@mercurymed.com (Domestic) and InternationalCustomerService@mercurymed.com (International) to assist you on how to send the affected product back to the firm for product replacement or credit.\n3) Please notify all personnel subject to using these devices. \n4) Complete and return the response form via email to regulatoryaffairs@mercurymed.com\n\nIn addition, distributors were asked to do the following:\n5) Provide a copy of this recall notice to all customers who have received impacted product. Each of your customers is then required to complete the Acknowledgement Form and return it to you.\n\nIf you have any questions regarding this action, contact the firm at 800-237-6418/727-573-0088, or e-mail at regulatoryaffairs@mercurymed.com", "product_quantity": "37370", "distribution_pattern": "Worldwide Distribution: US (nationwide) to states of: PA, FL, IN, WI, ME, SC, WY, ID, MT, TX, MI, LA, MS, AR, WV, MD, KY, NJ, WA, CA, GA, MO, MA, NC, NV, TN, VA, OK, ND, MN, AL, HI, UT, NY, AZ, IL, OH, IA, NE, CT, AK, OR and OUS (foreign) to countries of: Hungary, Switzerland, Hong Kong, Spain, Canada, Italy, United Kingdom, United Arab Emirates, Saudi Arabia, France, Netherlands", "openfda": { "k_number": [ "K855092", "K830404", "K973975", "K083385", "K090356", "K913039", "K001430", "K142096", "K221634", "K092085", "K882833", "K071527", "K080692", "K851337", "K911261", "K771299", "K780168", "K932170", "K921926", "K083507", "K140707", "K910434", "K951126", "K123957", "K030803", "K132021", "K944397", "K884089", "K861272", "K161420", "K904920", "K792453", "K070120", "K910435", "K072214", "K944349", "K910699", "K093862", "K162968", "K932200", "K051322", "K021841", "K920910", "K193191", "K051889", "K860077", "K102542", "K895946", "K862192", "K132759", "K141595", "K941870", "K982225", "K960515", "K841893", "K941871", "K112783", "K874656", "K915564", "K862830", "K870424", "K040090", "K093913", "K901846", "K073261", "K983705", "K202219", "K021520", "K093261", "K991195", "K932199", "K041473", "K905697", "K131098", "K080063", "K182956", "K032386", "K924272", "K983857", "K983643", "K043495", "K800456", "K081330", "K892885", "K070636", "K131877", "K020899", "K071221", "K863410", "K140049", "K910201", "K070210", "K051476", "K991785", "K931473", "K051469", "K983785", "K173373", "K242769", "K853971" ], "device_name": "Ventilator, Emergency, Powered (Resuscitator)", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5925", "device_class": "2", "registration_number": [ "", "9681209", "3005783425", "1625392", "3006783791", "2085602", "3036470679", "3031754300", "2951529", "3014220748", "2022648", "8043316", "1526863", "9611500", "9616567", "3005652389", "3015997711", "3009746061", "9610861", "3012542015", "3025434453", "3008729547", "3030733800", "3008342612", "9611451", "3017365972", "3013557562", "3005998497", "3044994756", "3005803793", "3012104670", "3020460367", "8044169", "3007734888", "3024290085", "1924066", "3008258694", "3009884346", "1024404", "3020476987", "3003697063", "1823393", "2134752", "2025816", "1314417", "2518436" ], "fei_number": [ "", "3005783425", "3003319165", "3006783791", "1000307109", "3000210616", "3036470679", "3031754300", "1000283452", "3014220748", "2022648", "1526863", "3015997711", "3009746061", "3003007822", "3012542015", "3002628192", "3025434453", "3008729547", "3004846435", "1000058335", "3030733800", "3008342612", "3017365972", "3013557562", "3005998497", "3044994756", "3005803793", "3002963732", "3012104670", "3020460367", "3007734888", "3024290085", "1924066", "3008258694", "3001104093", "3002807836", "3009884346", "1024404", "3020476987", "3003697063", "1823393", "2025816", "1314417", "2518436", "3002806988" ] } } ] }