{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "219911", "product_res_number": "Z-2638-2026", "event_date_initiated": "2026-04-21", "event_date_posted": "2026-07-01", "recall_status": "Open, Classified", "res_event_number": "98833", "product_code": "GDC", "product_description": "Adapter for Head Positioning, Model/Catalog Number: 1739994, when used in conjunction with the side rails of the Upper Back Section H V U component (product code 1909813) on Baxter operating tables", "code_info": "Lot Code: Product Code: 1739994\nUDI-DI: 00887761972780\nSerial Numbers: 109931797, 109931798, 109931799, 109943588, 109943590, 109948550, 109964963, 109964964, 109964969, 109964970, 109964971, 109980700, and 110006694", "firm_fei_number": "1417572", "recalling_firm": "Baxter Healthcare Corporation", "address_1": "1 Baxter Pkwy", "city": "Deerfield", "state": "IL", "postal_code": "60015-4625", "additional_info_contact": "Center for One Baxter\n1-847-9484770", "reason_for_recall": "The Adapter for Head Positioning accessory may become loose during patient positioning and unintentionally move when used in conjunction with the side rails of the Upper Back Section H V U component on Baxter operating tables.", "root_cause_description": "Device Design", "action": "An URGENT PRODUCT RECALL notification letter dated 4/20/26 was sent to customers.\n\nActions to be Taken by Customers\n1. Please notify all users of the product affected within your facility, especially all operating room staff. The affected Adapters may continue to be used only when mounted directly to the side rails of the operating table back plate.\nDo not use the Adapter on the Upper Back Section H V U side rails (component). Using the Upper Back Section H V U (separate component which is attached to the operating table s back plate) in conjunction with the Adapter accessory must be stopped/ceased, until a replacement takes place.\n2. Once the newly designed Adapters are available Baxter will contact customers with instructions for return and replacement of the impacted Adapters.\n3. If you received this communication directly from Baxter, acknowledge receipt by following the within the body of the corresponding email. Acknowledging receipt of this notification will prevent you from receiving repeated notices. If you do not complete the acknowledgement, you will receive a phone call from Accenture LLP on behalf of Baxter to confirm your receipt of this notification.\n4. If you purchased this product from a distributor or wholesaler, please contact your supplier to arrange for return of the affected product. Please note that responding on the Baxter customer portal is not applicable. If a response is requested by your distributor or wholesaler, please respond to them according to their instructions.\n5. Please forward a copy of this communication to the director of nursing, facility risk manager, patient safety, biomedical engineering department, director of surgical services, operating room staff, and any other departments within your institution who use the affected product.\n6. If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please conduct a user-level recall of", "product_quantity": "13 units", "distribution_pattern": "Worldwide - US Nationwide distribution in the states of Minnesota, Maryland, and Pennsylvania and the countries of Canada, Hong Kong, India, Japan, Korea, Philippines, Taiwan, Thailand, Vietnam, Austria, Belgium, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iraq, Israel, Italy, Jordan, Kenya, Lebanon, Libya, Malta, Morocco, Netherlands, Norway, Oman, Pakistan, Poland, Portugal, Qatar, Romania, Saudi Arabia, Senegal, Serbia, Slovakia, Spain, Sweden, Switzerland, Tunisia, Turkey, United Arabia Emrites, Ukraine, Argentina, Brazil, Chile, Colombia, Costa Rica, Mexico, and Peru.", "openfda": { "k_number": [ "K970807", "K851021", "K853720", "K821749", "K851829", "K850168", "K821665", "K914758", "K964273", "K934744", "K851830", "K843134", "K853535", "K883613", "K853480", "K971390", "K940616", "K915393" ], "registration_number": [ "", "9680579", "3033433849", "3003574554", "3010890274", "3030558088", "3029970239", "9610617", "3030681105", "2020550", "3015286905", "3011537487", "3015515531", "3005083075", "3015223105", "3008610343", "3010326005", "1043572", "3006063136", "3006975482", "9611102", "9611503", "3042991836", "8030607", "3005607354", "3009129579", "3006223081", "9680168", "3030194752", "3042992004", "3043177791", "3010202439", "3007417753", "3021839632", "3020703842", "2182536", "3009567010", "3005843419", "3030516433", "3035678069", "3042970964", "3015376465", "3034669683", "3014342096", "2916714", "3014680784", "1412854", "3010373494", "2247992", "3012010520", "3017884063", "3009610508", "9613910", "3015468226", "3002532594", "3008388379", "3003851947", "3012165496", "9680242", "3010446656", "1648279", "3027520367", "3003749961", "1824206", "8021896", "3003898943", "1643264", "3021559257", "3043654660", "3009715914", "3013836619", "3027847726", "1836161", "3031700059", "3006142326", "9681454", "3037012186", "3003604053", "3007278668", "1066635", "3003696170", "1825014", "3011659880", "3012708860", "3007123908", "3007238566", "3011647337", "3006897996", "3017181414", "1066270", "3011547624", "3025628903", "3031582440", "3015131225", "9710385", "3011574775", "1000122786", "3016590299", "3007143268", "3008881803", "3010594257", "3013774640", "1066427", "3003900596", "8010153", "3006697241", "3011580044", "1717548", "2031963", "3010373263", "3014302716", "3013846070", "3023449169", "3009212453", "3043178571" ], "fei_number": [ "", "3033433849", "3002750084", "3003574554", "1000203464", "3001168737", "3010890274", "3030558088", "3029970239", "3030681105", "2020550", "3015286905", "3011537487", "1000516389", "3015515531", "3015223105", "3008610343", "3010326005", "3005083075", "1043572", "3006063136", "3006975482", "3007513035", "3007475226", "3042991836", "3005607354", "3009129579", "3006223081", "3030194752", "3042992004", "3043177791", "3007417753", "3006509795", "3020703842", "2182536", "3009567010", "3005843419", "1000125341", "3030516433", "3035678069", "3009504761", "3042970964", "3015376465", "3034669683", "3014342096", "2916714", "3003184737", "1412854", "3010373494", "3012010520", "3017884063", "3009610508", "3002808001", "1000208827", "3000957797", "3015468226", "3002532594", "3008388379", "3002975342", "3012165496", "3003851947", "3010446656", "3003138129", "3027520367", "3003749961", "3002572935", "1824206", "3003898943", "1643264", "3021559257", "1825560", "3043654660", "3009715914", "3013836619", "3002808335", "3006125657", "3027847726", "3031700059", "3002808268", "3006142326", "3037012186", "3003604053", "3007278668", "3003696170", "1825014", "3011659880", "3012708860", "3007123908", "3007238566", "3011647337", "3006897996", "3017181414", "3011547624", "3025628903", "3031582440", "1000295034", "3015131225", "3004574120", "3011574775", "1000122786", "3016590299", "3007143268", "3008881803", "3010594257", "3013774640", "3003900596", "3006697241", "3011580044", "1717548", "3010373263", "3014302716", "3013846070", "3023449169", "3009212453", "3043178571" ], "device_name": "Table, Operating-Room, Electrical", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4960", "device_class": "1" } } ] }