{ "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": "2026-06-04", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "219942", "product_res_number": "Z-2278-2026", "event_date_initiated": "2026-05-06", "event_date_posted": "2026-06-03", "recall_status": "Open, Classified", "res_event_number": "98838", "product_code": "OFU", "product_description": "Design Options Spinal Tray\r\nMaterial Description (Material Number):\r\nSSK HACKENSACK MEDICAL CTR 20061890 (560074), \r\nSSK SUTTER COMMUNITY HOSPITAL (560214), \r\nSSK BJC HEALTH SYSTEMS (ORIGINAL CUST) (560272), \r\nSSK CA PACIFIC MED. CTR (ORIGINAL CUST) (560327), \r\nSSK TORRANCE MEMORIAL HOSPITAL (560394), \r\nSSK SURGERY ONE 20070208 (560428), \r\nSSK LUTHERN GENERAL HOSP (ORIGINAL CUST) (560462), \r\nSSK HOAG MEMORIAL HOSPITAL (560465), \r\nSSK BUPIVACAINE TRAY 2068824 (560476), \r\nSSK KAISER FOUNDATION HOSPITAL (560497), \r\nSSK THOMAS JEFFERSON UNIV HOSP (560513), \r\nSSK OVERLAKE MEDICAL CENTER (560521), \r\nSSK CUSTOM SPINAL TRAY (560523), \r\nSSK ORLANDO REGIONAL MED CENTER (560533), \r\nSSK BON SECOURS HEALTH SYS 20115122 (560538), \r\nSSK MANATEE MEMORIAL (560572), \r\nSSK MOUNT SINAI 27GA PENCAN SPINAL TRAY (560580), \r\nSSK SHANDS TEACHING HOSP. & CLINICS, INC (560584), \r\nSSK UNIVERSITY OF COLORADO (560587),\r\nSSK P25BKG (560603), \r\nSSK P24BKG (560606), \r\nSSK S25BKG (560607), \r\nSSK MAYO CLINIC - BUPIVACAINE TRAY (560609), \r\nSSK THE MEDICAL CENTER (560613), \r\nSSK PENCIL POINT SPINAL TRAY (560619), \r\nSSK EMORY ORTHO & SPINE HOSPITAL-SPINAL (560621), \r\nSSK BSW SPINAL TRAY (560628), \r\nSSK MAYO CLINIC OB DEPT - SPINAL (560645), \r\nSSK BAPTIST HOSPITAL OF MIAMI (560646), \r\nSSK MERCY GILBERT MEDICAL CENTER (560647), \r\nSSK ST.MARY'S HOSPITAL (560648), \r\nSSK HARRIS HEALTH SYSTEM (560660), \r\nOHIO STATE U MEDICAL CTR SPINAL TRAY SSK (560667), \r\nALBANY MEDICAL CENTER, SSK (560670), \r\nSTONY BROOK HOSPITAL - SPINAL TRAY SSK (560672);", "code_info": "1. Material: 560074; UDI-DI Primary/Individual Unit of Use: 04046964317873/04046964317859; Batch Numbers: 0061960383, 0061972565;\n2. Material: 560214; UDI-DI Primary/Individual Unit of Use: 04046964318061/04046964318054; Batch Numbers: 0061971346, 0061977782;\n3. Material: 560272; UDI-DI Primary/Individual Unit of Use: 04046964318108/04046964318085; Batch Numbers: 0061960367, 0061971330;\n4. Material: 560327; UDI-DI Primary/Individual Unit of Use: 04046964318221/04046964318207; Batch Numbers: 0061960420, 0061977751;\n5. Material: 560394; UDI-DI Primary/Individual Unit of Use: 04046964318429/04046964318405; Batch Numbers: 0061964747, 0061976985, 0061983313;\n6. Material: 560428; UDI-DI Primary/Individual Unit of Use: 04046964318610/04046964318597; Batch Numbers: 0061976150, 0061979927;\n7. Material: 560462; UDI-DI Primary/Individual Unit of Use: 04046964318764/04046964318740; Batch Number: 0061977772;\n8. Material: 560465; UDI-DI Primary/Individual Unit of Use: 04046964318801/04046964318788; Batch Numbers: 0061976120, 0061976122, 0062024615;\n9. Material: 560476; UDI-DI Primary/Individual Unit of Use: 04046964318948/04046964318931; Batch Numbers: 0061964879, 0061977776, 0061985361;\n10. Material: 560497; UDI-DI Primary/Individual Unit of Use: 04046964319136/04046964319112; Batch Numbers: 0061967077, 0061985362;\n11. Material: 560513; UDI-DI Primary/Individual Unit of Use: 04046964319273/04046964319259; Batch Numbers: 0061961836, 0061977766;\n12. Material: 560521; UDI-DI Primary/Individual Unit of Use: 04046964319440/04046964319426; Batch Numbers: 0061967083, 0061977226;\n13. Material: 560523; UDI-DI Primary/Individual Unit of Use: 04046964319471/04046964319457; Batch Numbers: 0061952176, 0061971321;\n14. Material: 560533; UDI-DI Primary/Individual Unit of Use: 04046964319518/04046964319495; Batch Numbers: 0061954120, 0061971287, 0061971288;\n15. Material: 560538; UDI-DI Primary/Individual Unit of Use: 04046964319587/04046964319563; Batch Numbers: 0061971325, 0061973771;\n16. Material: 560572; UDI-DI Primary/Individual Unit of Use: 04046964319990/04046964319976; Batch Number: 0061961001;\n17. Material: 560580; UDI-DI Primary/Individual Unit of Use: 04046964320194/04046964320170; Batch Number: 0061967090;\n18. Material: 560584; UDI-DI Primary/Individual Unit of Use: 04046964320293/04046964320286; Batch Number: 0061961847;\n19. Material: 560587; UDI-DI Primary/Individual Unit of Use: 04046964320408/04046964320378; Batch Number: 0061972579;\n20. Material: 560603; UDI-DI Primary/Individual Unit of Use: 04046964320842/04046964320828; Batch Numbers: 0061951279, 0061954147, 0061958274, 0061969404, 0061969405, 0061970744, 0061974805;\n21. Material: 560606; UDI-DI Primary/Individual Unit of Use: 04046964320958/04046964320927; Batch Numbers: 0061965746, 0061965762, 0061971283, 0061971284, 0061971285;\n22. Material: 560607; UDI-DI Primary/Individual Unit of Use: 04046964320989/04046964320965; Batch Numbers: 0061958137, 0061972577, 0061985364;\n23. Material: 560609; UDI-DI Primary/Individual Unit of Use: 04046964321047/04046964321030; Batch Numbers: 0061958142, 0061975207, 0061985374;\n24. Material: 560613; UDI-DI Primary/Individual Unit of Use: 04046964321153/04046964321146; Batch Number: 0061972578;\n25. Material: 560619; UDI-DI Primary/Individual Unit of Use: 04046964321306/04046964321290; Batch Numbers: 0061954114, 0061971313;\n26. Material: 560621; UDI-DI Primary/Individual Unit of Use: 04046964321375/04046964321368; Batch Numbers: 0061961853, 0061976112, 0061977798; \n27. Material: 560628; UDI-DI Primary/Individual Unit of Use: 04046964526749/04046964526732; Batch Numbers: 0061954111, 0061959460;\n28. Material: 560645; UDI-DI Primary/Individual Unit of Use: 04046964809088/04046964809071; Batch Numbers: 0061967991, 0061977778;\n29. Material: 560646; UDI-DI Primary/Individual Unit of Use: 04046964809101/04046964809095; Batch Number: 0061957394;\n30. Material: 560647; UDI-DI Primary/Individual Unit of Use: 04046964809125/04046964809118; Batch Numbers: 0061971336, 0061977571, 0061985370;\n31. Material: 560648; UDI-DI Primary/Individual Unit of Use: 04046964809149/04046964809132; Batch Numbers: 0061961002, 0061977800, 0061977801; \n32. Material: 560660; UDI-DI Primary/Individual Unit of Use: 04046955331864/04046955331857; Batch Number: 0061958133;\n33. Material: 560667; UDI-DI Primary/Individual Unit of Use: 04046955595891/04046955595884; Batch Numbers: 0061966001, 0061976124, 0061977803;\n34. Material: 560670; UDI-DI Primary/Individual Unit of Use: 04046955595945/04046955595938; Batch Number: 0061972569;\n35. Material: 560672; UDI-DI Primary/Individual Unit of Use: 04046955595983/04046955595976; Batch Numbers: 0061967078, 0061977783;", "firm_fei_number": "2521402", "recalling_firm": "B Braun Medical Inc", "address_1": "824 12th Ave", "city": "Bethlehem", "state": "PA", "postal_code": "18018-3524", "additional_info_contact": "Allison Longenhagen\n001-484-2408373", "reason_for_recall": "A sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. Huon Co, Ltd. has issued a voluntary recall due to potential quality issues.", "root_cause_description": "Under Investigation by firm", "action": "On May 6, 2026, URGENT MEDICAL DEVICE RECALL were sent to customers. \nActions to be taken: \n- Check inventory for affected product and return to B Braun. The return process will begin when B Braun received the Acknowledgement Form.)\n- If you are a distributor and have further distributed the product, please forward this notice to your consignees. This recall is to be extended to the hospital/healthcare facility level.\nShould there be any questions, comments, or concerns, please feel free to contact us via email at recalls@bbraunusa.com or via phone at 844-903-6417 Monday through Friday, 8:00am-5:00pm EST.", "product_quantity": "104,720 units", "distribution_pattern": "US Nationwide distribution.", "openfda": { "device_name": "Spinal Anesthesia Kit", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5120", "device_class": "2", "registration_number": [ "1018470", "2523676", "9611612", "1423537", "3007329020", "1061124", "3013764800", "3004111573", "2521402", "1061927", "3008552585", "1643817", "9616088", "3006450239", "3004076349", "3009888344" ], "fei_number": [ "1018470", "2523676", "3002807847", "3007329020", "3002902735", "3013764800", "3004111573", "2521402", "1643817", "3008552585", "3000203000", "3006450239", "3004076349", "1000512168", "3009888344", "3001236905" ] } } ] }