Agency classClass IOur severity:Severe FDA (Devices)·Z-2277-2026·Announced 2026-06-10

Spinocan spinal needle kits recalled over Huons bupivacaine quality issues

Spinocan spinal needle procedure kits are being recalled because they contain Bupivacaine Hydrochloride in Dextrose Injection subject to the Huons recall. 16,080 units affected.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I recall, which the rubric floors at Severe; no death is reported in the source, so it does not escalate to Critical.

Plain-English summary

Spinocan spinal needle procedure kits are being recalled, including Spinocan 26 Ga. x 3-1/2 in. with Bupivacaine 0.75% and Dextrose 8.25% Tray (material 333201) and the 25 Ga. equivalent, among others listed in the recall notice. The action covers 16,080 units.

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. The FDA classified the action as Class I, its most serious classification.

Distribution was nationwide in the United States. The kits are supplied to healthcare facilities rather than sold to consumers.

Facilities should identify affected kits using the material numbers, UDI-DI codes and batch numbers in the recall notice, quarantine any stock on hand, and follow the instructions issued by the manufacturer.

The recalled product

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)…
Manufacturer: B Braun Medical Inc
Category: Medical Device — Spinal anesthesia tray
Hazard: contained-drug-recall
quality-issues
class-i
spinal-anesthesia
Affected units: 16,080

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (11)

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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by B Braun Medical Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · B Braun Medical Inc

See all →

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