B Braun Medical Inc Recalls Spinal Needle Procedure Kits
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 multiple spinal needle procedure kits containing Bupivacaine due to potential quality issues from the drug manufacturer.
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, MedicalDevices.
What Happened
B Braun Medical Inc has initiated a voluntary recall of spinal needle procedure kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huon Co, Ltd., issued a voluntary recall due to potential quality issues identified during a recent FDA manufacturing facility inspection.
Which Products Are Affected
The recall affects 582,030 units distributed nationwide in the United States. Affected products include:
- 24GA. PENCAN SPINAL BUP. TRAY W/DURAPREP (333867)
- 25GA. PENCAN SPINAL BUP. TRAY W/DURAPREP (333862)
- GOVP24BK 24G PENCAN TRAY W/ BUP & DEXTROS (332607)
- P24BK 24G PENCAN TRAY W/BUP & DEXTROSE (333868)
- P25BKAY PENCAN SPINAL TRAY (333865)
- P27BK PENCAN SPINAL W/BUPIVAC (333871)
- P25BK SPINAL TRAY (333851)
Specific UDI-DI and batch numbers are listed in the recall notice. The recall number is Z-2276-2026. This is a Class I recall.
What You Should Do
Consumers should follow instructions provided by B Braun Medical Inc regarding the recalled kits.
Why This Matters
The recall involves over 582,000 units distributed nationwide and is classified as Class I due to potential quality issues with the included medication.
Source
FDA recall notice: https://www.fda.gov (Event ID: 98838, Report Date: 20260610)
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 (1,308 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.