B Braun Spinocan Spinal Needle Kits Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
B Braun Medical Inc. is recalling 16,080 units of Spinocan Spinal Needle procedure kits due to potential quality issues with the included Bupivacaine Hydrochloride in Dextrose Injection, USP.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on July 10, 2026 and geographically references United States. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, medical-devices.
What Happened
B Braun Medical Inc. initiated a voluntary recall of certain Spinocan Spinal Needle procedure kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP manufactured by Huon Co, Ltd. The recall is due to potential quality issues identified during a recent FDA manufacturing facility inspection. This is a Class I recall with US Nationwide distribution.
Which Products Are Affected
The affected products are:
- Spinocan 26 Ga. x 3-1/2 in. (90 mm), Bupivacaine 0.75% with Dextrose 8.25% Tray (Kit) (Material Number 333201); UDI-DI: 4046964179365/4046964179358; Batch Number: 0061976152
- Spinocan 25 Ga. x 3-1/2 in. (90 mm), Bupivacaine 0.75% with Dextrose 8.25% Tray (Kit) (Material Number 333211); UDI-DI: 4046964179389/4046964179372; Batch numbers: 0061965729, 0061971323, 0061972572
- Spinocan 22 Ga. x 3-1/2 in. (90 mm), Bupivacaine 0.75% with Dextrose 8.25% Tray (Kit) (Material Number 333231); UDI-DI: 4046964179488/4046964179471; Batch Number: 0061978177 A total of 16,080 units are affected under recall number Z-2277-2026.
What You Should Do
Consumers and healthcare providers should follow guidance from the recalling firm regarding the affected kits.
Why This Matters
This Class I recall involves medical devices distributed nationwide that contain a drug component subject to potential quality issues.
Source
FDA recall Z-2277-2026; B Braun Medical Inc., Bethlehem, PA. https://www.fda.gov
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,443 characters here).
Similar severity timing
Same severity (high) notices issued closest in time to July 10, 2026.
Frequently Asked Questions
Common questions about this FDA recall.