The Recall Desk
HighFDA (Devices)·Z-2276-2026·Announced 2026-06-10

[pending] Spinal Needle procedure kits: Material Description (Material Number) 24GA. PENCAN SPINAL BUP. TRA

Pending LLM rewrite. Source: FDA_DEVICE Z-2276-2026.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

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 recalled product

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); P
Manufacturer
B Braun Medical Inc
Category
Medical Device — Devices

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed nationwide across the United States.

Related recalls

Same category