Reported Jun 10, 2026 · Ongoing
Spinal Needle procedure kits
B Braun Medical Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: B Braun Medical Inc · 824 12th Ave · Bethlehem, PA · 18018-3524
Is this the product you have?
Spinal Needle procedure kits
7 of 7 products
| # | Product as published |
|---|---|
| 1 | Material Description (Material Number) 24GA. PENCAN SPINAL BUP. TRAY W/DURAPREP (333867) |
| 2 | 25GA. PENCAN SPINAL BUP. TRAY W/DURAPREP (333862) |
| 3 | GOVP24BK 24G PENCAN TRAY W/ BUP & DEXTROS (332607) |
| 4 | P24BK 24G PENCAN TRAY W/BUP & DEXTROSE (333868) |
| 5 | P25BKAY PENCAN SPINAL TRAY (333865) |
| 6 | P27BK PENCAN SPINAL W/BUPIVAC (333871) |
| 7 | P25BK SPINAL TRAY (333851) |
- Lot codes and dates
21 of 21 products
Products covered by this recall # Barcodes Product as published 1 333867 2 40469641808424046964180835UDI-DI Primary/Unit of Use: 4046964180842/4046964180835 3 Batch Numbers: 0061965993, 0061968406, 0061971306, 0061971487, 0061978629, 0061978630 4 Material: 333862 5 40469641807434046964180736UDI-DI Primary/Unit of Use: 4046964180743/4046964180736 6 Batch Numbers: 0061947858, 0061954126, 0061970779, 0061970781, 0061970783 7 Material: 332607 8 40469645587574046964558740UDI-DI Primary/Unit of Use: 4046964558757/4046964558740 9 Batch Number: 0061976109 10 Material: 333868 11 40469641808664046964180859UDI-DI Primary/Unit of Use: 4046964180866/4046964180859 12 Batch Numbers: 0061958120, 0061958276, 0061960474, 0061960475, 0061960476, 0061960477, 0061960478, 0061965732, 0061965733, 0061965734, 0061965735, 0061965736, 0061965737, 0061965738, 0061965739, 0061965740, 0061965741, 0061965743, 0061969393, 0061969394, 0061969395, 0061969397, 0061969438, 0061969439, 0061969440, 0061969441, 0061970674, 0061970675, 0061970726, 0061970727, 0061970729, 0061970730, 0061971108, 0061975011, 0061975012, 0061975013, 0061975014, 0061975015, 0061975016, 0061975017, 0061975018, 0061976996, 0061976997, 0061976998, 0061976999, 0061979852 13 Material: 333865 14 40469641808044046964180798UDI-DI Primary/Unit of Use: 4046964180804/4046964180798 15 Batch Numbers: 0061952152, 0061964964, 0061968295 16 Material: 333871 17 40469641809034046964180897UDI-DI Primary/Unit of Use: 4046964180903/4046964180897 18 Batch Number: 0061954099 19 Material: 333851 20 40469641806064046964180590UDI-DI Primary/Unit of Use: 4046964180606/4046964180590 - Amount recalled
- 582,030 units
This recall covers 11 products
The agency filed one notice per product. You are reading one of them; the other 10 are below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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