B Braun Medical Inc recalls Spinal Needle procedure kits: Material Description
- Recalling company
- B Braun Medical Inc
- 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
- 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.
- Classification
- Class I – a reasonable probability that use will cause serious adverse health consequences or death
- Recall date
- May 6, 2026
- Reported
- Jun 10, 2026
- Distribution
- US Nationwide distribution.
- Status
- Ongoing
- Quantity
- 582,030 units
- Lot / codes
- 1. Material: 333867; UDI-DI Primary/Unit of Use: 4046964180842/4046964180835; Batch Numbers: 0061965993, 0061968406, 0061971306, 0061971487, 0061978629, 0061978630; 2. Material: 333862; UDI-DI Primary/Unit of Use: 4046964180743/4046964180736; Batch Numbers: 0061947858, 0061954126, 0061970779, 0061970781, 0061970783; 3. Material: 332607; UDI-DI Primary/Unit of Use: 4046964558757/4046964558740; Batch Number: 0061976109; 4. Material: 333868; UDI-DI Primary/Unit of Use: 4046964180866/4046964180859; 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; 5. Material: 333865; UDI-DI Primary/Unit of Use: 4046964180804/4046964180798; Batch Numbers: 0061952152, 0061964964, 0061968295; 6. Material: 333871; UDI-DI Primary/Unit of Use: 4046964180903/4046964180897; Batch Number: 0061954099; 7. Material: 333851; UDI-DI Primary/Unit of Use: 4046964180606/4046964180590; Batch Numbers: 0061954106, 0061954107, 0061954108, 0061954123, 0061954124, 0061954125, 0061954130, 0061954131, 0061954132,
- Company location
- Bethlehem, PA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2276-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2276-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.