FDA Class I Recall: Spinal Needle procedure kits: Material Description (Material Number)… by B Braun Medical Inc

Key facts

What consumers should do

Because FDA has assigned this recall its highest severity classification, anyone who has this product should stop using it immediately, regardless of whether a problem has been noticed yet. Specifically, check whether the product in your possession matches the description on file with FDA -- Spinal Needle procedure kits: Material Description (Material Number) 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) (additional items listed in FDA's full record) -- and the recall number Z-2276-2026. If it matches, stop using or distributing it and contact B Braun Medical Inc or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice.

What this classification means

FDA classifies a recall as Class I when there is a reasonable probability that using the recalled product, or being exposed to it, will cause serious adverse health consequences or death. Class I is FDA's most serious recall classification. In this case, the recalling firm is B Braun Medical Inc and the affected product is described in FDA's record as: Spinal Needle procedure kits: Material Description (Material Number) 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) (additional items listed in FDA's full record). FDA's stated reason for the recall is: These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huon Co, Ltd., has issued a voluntary recall due to potential quality issues identified during a recent FDA manufacturing facility inspection.. The recall is tracked under FDA recall number Z-2276-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.

B BRAUN MEDICAL INC’s FDA history

Argus HQ has recorded 22 total FDA actions tied to B BRAUN MEDICAL INC: 0 warning letters, 22 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

Has B Braun Medical Inc had other FDA recalls or enforcement actions?

Yes. Argus HQ has recorded 22 total FDA actions tied to B Braun Medical Inc, including 22 recalls and 0 warning letters.

What is the FDA recall number for this event?

FDA recall number Z-2276-2026.

What is the current status of this recall?

Status as recorded by FDA: Ongoing.

Where can I verify this recall directly with FDA?

The verbatim FDA record is the source of truth for every recall Argus HQ tracks — always confirm against fda.gov before acting.

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