B Braun Medical Spinal Trays Recall

Source: FDA · United States

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B Braun Medical Inc. is recalling 104,720 units of Design Options Spinal Tray anesthesia procedure kits nationwide due to potential quality issues with contained 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 11, 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 read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, fda, Devices) map to related alerts in the same area of risk - browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.

What Happened

B Braun Medical Inc. initiated a voluntary Class I recall of multiple Design Options Spinal Tray Spinal Needle Anesthesia procedure kits. The kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP manufactured by Huon Co, Ltd., which issued a voluntary recall due to potential quality issues identified during a recent FDA manufacturing facility inspection.

Which Products Are Affected

The recall covers 104,720 units distributed nationwide in the United States. Affected products include numerous material numbers such as 560074, 560214, 560272, 560327, 560394, 560428, 560462, 560465, 560476, 560497, 560513, 560521, 560523, 560533, 560538, 560572, 560580, 560584, 560587, 560603, 560606, 560607, 560609, 560613, 560619, 560621, 560628, 560645, 560646, 560647, 560648, 560660, 560667, 560670, and 560672. Specific UDI-DI and batch numbers are listed in the recall notice. Recall number: Z-2278-2026. Recall initiation date: May 6, 2026.

What You Should Do

Consumers should check the material number, UDI-DI, and batch number on their products against the detailed list in the FDA recall notice. No additional consumer instructions are provided in the source data.

Why This Matters

This is a Class I recall involving 104,720 units distributed nationwide, indicating a situation in which there is a reasonable probability that the use of or exposure to the product will cause serious adverse health consequences or death.

Source

FDA recall Z-2278-2026 (event ID 98838), B Braun Medical Inc., Bethlehem, PA.

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
B Braun Medical Inc. is recalling 104,720 units of Design Options Spinal Tray anesthesia procedure kits nationwide due to potential quality issues with contained Bupivacaine Hydrochloride in Dextrose Injection, USP.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "high" severity. Take precautions and monitor for updates.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.