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High risk Medical DevicesClass I

B. Braun Spinocan Spinal Needle Kit Recall

Spinocan Spinal Needle procedure kits: Material Description (Material Number): Spinocan 26 Ga. x 3-1/2 in. (90 mm), Bupivacaine 0.75% with D

Updated May 6, 2026

B. Braun Medical is recalling three Spinocan spinal needle procedure kits that contain Bupivacaine 0.75% with Dextrose 8.25% injection. The bupivacaine inside may have quality defects identified during an FDA manufacturing inspection, raising serious safety concerns for patients receiving spinal anesthesia.

Is the B Braun Medical Inc recalled? Yes. This product was recalled by FDA on May 6, 2026. Details below.

What is recalled

B. Braun Medical Inc. Spinocan Spinal Needle Procedure Kits containing Bupivacaine Hydrochloride 0.75% with Dextrose 8.25% Injection, USP. Three kits are affected, identified by 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)

Am I affected

You are affected if your facility holds any of these B. Braun Spinocan spinal needle procedure kits. Check the material number printed on the kit packaging: 333201, 333211, or 333231. All three contain Bupivacaine 0.75% with Dextrose 8.25% and are covered by this recall.

What to do right now

Stop using and quarantine any affected kits immediately. This recall is directed at healthcare facilities and distributors. Contact B. Braun Medical Inc. or your product supplier for return and replacement instructions. Check the FDA recall page at fda.gov/safety/recalls-market-withdrawals-safety-alerts for any updated contact details as they become available.

The hazard

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.

Brands affected

B Braun Medical Inc
Source
FDA
Category
Medical Devices
Recall ID
fda-Z-2277-2026
Classification
Class I
Recalled
May 6, 2026
Read the official notice

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