{"url_path":"/fda/device/recalls/Z-2277-2026","section_key":"summary","section_title":"DEVICE Recall: B Braun Medical Inc — Spinocan Spinal Needle procedure kits:   Material Description (Material Number):  Spinocan 26 Ga. x 3-1/2 in. (90 mm), Bupivacaine 0.75% with Dextrose 8.25% Tray (Kit) (333201);  Spinocan 25 Ga. x 3-1/2 in. (90 mm), Bupivacaine 0.75% with Dextrose 8.25% Tray (Kit) (333211);  Spinocan 22 Ga. x 3-1/2 in. (90 mm), Bupivacaine 0.75% with Dextrose 8.25% Tray (Kit) …","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-05-06","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2277-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"B Braun Medical Inc"},"word_count":165,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2277-2026\n\n**Recalling firm:** B Braun Medical Inc\n**Classification:** Class I\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-05-06\n**Report date:** 2026-06-10\n\n## Product\nSpinocan Spinal Needle procedure kits:   Material Description (Material Number):  Spinocan 26 Ga. x 3-1/2 in. (90 mm), Bupivacaine 0.75% with Dextrose 8.25% Tray (Kit) (333201);  Spinocan 25 Ga. x 3-1/2 in. (90 mm), Bupivacaine 0.75% with Dextrose 8.25% Tray (Kit) (333211);  Spinocan 22 Ga. x 3-1/2 in. (90 mm), Bupivacaine 0.75% with Dextrose 8.25% Tray (Kit) (333231)\n\n## Reason\nThese procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huon Co, Ltd., has issued a voluntary recall due to potential quality issues identified during a recent FDA manufacturing facility inspection.\n\n## Affected lots\n1. Material: 333201; UDI-DI Primary/Unit of Use: 4046964179365/4046964179358; Batch Number: 0061976152; 2. Material: 333211; UDI-DI Primary/Unit of Use: 4046964179389/4046964179372; Batch numbers: 0061965729, 0061971323, 0061972572; 3. Material: 333231; UDI-DI Primary/Unit of Use: 4046964179488/4046964179471; Batch Number: 0061978177;\n\n## Distribution\nUS Nationwide distribution."}