FDA Device recall Z-2277-2026
Spinocan Spinal Needle procedure kits: Material Description (Material Number): Spinocan 26 Ga. x 3-1/2 in. (90 mm), Bupivacaine 0.75% with…
- FDA Device
- Class I
- ongoing
- Published 2026-06-10
On 2026-06-10 the FDA classified a Class I recall of Spinocan Spinal Needle procedure kits: Material Description (Material Number): Spinocan 26 Ga. x 3-1/2 in. (90 mm), Bupivacaine 0.75% with… by B Braun Medical, citing these procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huons Co, Ltd., has issued a voluntary recall due to potent….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2277-2026 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2026-05-06 |
| Published | 2026-06-10 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | B Braun Medical |
| Distribution | US |
Product
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) (333231)
Reason
These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huons Co, Ltd., has issued a voluntary recall due to potential quality issues identified during a recent FDA manufacturing facility inspection.
Identifiers
| code_info | 1. Material: 333201; UDI-DI Primary/Unit of Use: 4046964179365/4046964179358; Batch Number: 0061976152; 2. Material: 33…1. 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; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Other recalls by B Braun Medical
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FDA Device · Class II · 2026-09-09 · B Braun Medical - Lactated Ringer's Injection USP, 1000 mL EXCEL container, Rx only, L7500, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-77…
FDA Drug · Class I · 2026-09-02 · B Braun Medical - Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK SHANDS JACKSONVILLE 20055717 Model/Catalog Number: 555884 Software Version: N/A Produc…
FDA Device · Class II · 2026-06-10 · B Braun Medical - Design Options Spinal Tray Spinal Needle Anesthesia procedure kits: Material Description (Material Number): SSK H M C 20061890 (560074), SS…
FDA Device · Class I · 2026-06-10 · B Braun Medical
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2277-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.