{
  "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": "219939",
      "product_res_number": "Z-2276-2026",
      "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": "Material Description (Material Number)\r\n24GA. PENCAN SPINAL BUP. TRAY W/DURAPREP (333867);\r\n25GA. PENCAN SPINAL BUP. TRAY W/DURAPREP (333862);\r\nGOVP24BK 24G PENCAN TRAY W/ BUP & DEXTROS (332607);\r\nP24BK 24G PENCAN TRAY W/BUP & DEXTROSE (333868);\r\nP25BKAY PENCAN SPINAL TRAY (333865);\r\nP27BK PENCAN SPINAL W/BUPIVAC (333871);\r\nP25BK SPINAL TRAY (333851);",
      "code_info": "1. Material: 333867; UDI-DI Primary/Unit of Use: 4046964180842/4046964180835; Batch Numbers: 0061965993, 0061968406, 0061971306, 0061971487, 0061978629,\n0061978630;\n2. Material: 333862; UDI-DI Primary/Unit of Use: 4046964180743/4046964180736; Batch Numbers: 0061947858, 0061954126, 0061970779, 0061970781, 0061970783;\n3. Material: 332607; UDI-DI Primary/Unit of Use: 4046964558757/4046964558740; Batch Number: 0061976109;\n4. Material: 333868; UDI-DI Primary/Unit of Use: 4046964180866/4046964180859; Batch Numbers: 0061958120, 0061958276, 0061960474, 0061960475, 0061960476,\n0061960477, 0061960478, 0061965732, 0061965733, 0061965734,\n0061965735, 0061965736, 0061965737, 0061965738, 0061965739,\n0061965740, 0061965741, 0061965743, 0061969393, 0061969394,\n0061969395, 0061969397, 0061969438, 0061969439, 0061969440,\n0061969441, 0061970674, 0061970675, 0061970726, 0061970727,\n0061970729, 0061970730, 0061971108, 0061975011, 0061975012,\n0061975013, 0061975014, 0061975015, 0061975016, 0061975017,\n0061975018, 0061976996, 0061976997, 0061976998, 0061976999,\n0061979852;\n5. Material: 333865; UDI-DI Primary/Unit of Use: 4046964180804/4046964180798; Batch Numbers: 0061952152, 0061964964, 0061968295;\n6. Material: 333871; UDI-DI Primary/Unit of Use: 4046964180903/4046964180897; Batch Number: 0061954099;\n7. Material: 333851; UDI-DI Primary/Unit of Use: 4046964180606/4046964180590; Batch Numbers: 0061954106, 0061954107, 0061954108, 0061954123, 0061954124,\n0061954125, 0061954130, 0061954131, 0061954132, 0061954134,\n0061954135, 0061960457, 0061960458, 0061960459, 0061960460,\n0061960461, 0061965687, 0061965688, 0061965689, 0061967621,\n0061967623, 0061967624, 0061967626, 0061969508, 0061969986,\n0061970102, 0061970104, 0061970105, 0061970106, 0061970107,\n0061970109, 0061970110, 0061970860, 0061970861, 0061970863,\n0061970864, 0061970866, 0061970867, 0061971261, 0061971262,\n0061971263, 0061971264, 0061971265, 0061971266, 0061971268,\n0061971269, 0061972812, 0061972813, 0061974198, 0061974199,\n0061974200, 0061974201, 0061974247, 0061974248, 0061974249,\n0061974250, 0061974251, 0061974253, 0061974559, 0061974562,\n0061974563, 0061974564, 0061974569, 0061975004, 0061975005,\n0061975006, 0061975007, 0061975008, 0061975009, 0061975810,\n0061976903, 0061976904, 0061976905, 0061976906, 0061976908,\n0061976909, 0061976910, 0061976911, 0061976912, 0061976913,\n0061976914, 0061976915, 0061979785, 0061979786, 0061979787,\n0061979788, 0061979790, 0061979791, 0062019490;",
      "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": "582,030 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"
        ]
      }
    }
  ]
}