Spinal Needle procedure kits: Material Description — Class I medical device recall Z-2276-2026

Ongoing recall by B Braun Medical Inc, reported 2026-06-10, distributed nationwide. These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bup

Recall number	`Z-2276-2026`
Product type	Medical device
Classification	Class I
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	B Braun Medical Inc, Bethlehem, PA, United States
Recall initiated	2026-05-06
Classified	2026-06-03
Reported by FDA	2026-06-10
Distributed	Nationwide (US)
Quantity	582,030 units
UPC / GTIN / UDI-DI	`04046964180590`, `04046964180606`, `04046964180736`, `04046964180743`, `04046964180798`, `04046964180804`, `04046964180835`, `04046964180842`, `04046964180859`, `04046964180866`, `04046964180897`, `04046964180903`, `04046964558740`, `04046964558757`
Lot numbers	`0061947858`, `0061952152`, `0061954099`, `0061954106`, `0061954107`, `0061954108`, `0061954123`, `0061954124`, `0061954125`, `0061954126`, `0061954130`, `0061954131`, `0061954132`, `0061954134`, `0061954135`, `0061958120`, `0061958276`, `0061960457`, `0061960458`, `0061960459`, `0061960460`, `0061960461`, `0061960474`, `0061960475`, `0061960476`, `0061960477`, `0061960478`, `0061964964`, `0061965687`, `0061965688`, `0061965689`, `0061965732`, `0061965733`, `0061965734`, `0061965735`, `0061965736`, `0061965737`, `0061965738`, `0061965739`, `0061965740` and 111 more

Product

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); P25BKAY PENCAN SPINAL TRAY (333865); P27BK PENCAN SPINAL W/BUPIVAC (333871); P25BK SPINAL TRAY (333851)

Reason for recall

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2276-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.