The Recall Desk
SevereFDA (Devices)·Z-2278-2026·Announced 2026-06-10

Design Options spinal trays recalled over Huons bupivacaine quality issues

Design Options spinal needle anesthesia procedure kits are being recalled because they contain Bupivacaine Hydrochloride in Dextrose Injection subject to the Huons recall.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I recall, which the rubric floors at Severe; no death is reported in the source, so it does not escalate to Critical.

Plain-English summary

Design Options Spinal Tray spinal needle anesthesia procedure kits are being recalled, covering material numbers including 560074, 560214, 560272 and others listed in the recall notice. The action covers 104,720 units.

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. The FDA classified the action as Class I, its most serious classification.

Distribution was nationwide in the United States. The kits are supplied to healthcare facilities rather than sold to consumers.

Facilities should identify affected kits using the material numbers, UDI-DI codes and batch numbers in the recall notice, quarantine any stock on hand, and follow the instructions issued by the manufacturer.

The recalled product

Product
Design Options Spinal Tray Spinal Needle Anesthesia procedure kits: Material Description (Material Number): SSK H M C 20061890 (560074), SSK S C H (560214), SSK BJC H S (ORIGINAL CUST) (560272), SSK CA P M C (ORIGINAL CUST) (560327), SSK T M H (560394), SSK S O 20070208 (
Manufacturer
B Braun Medical Inc
Category
Medical Device — Spinal anesthesia tray
Hazard
Affected units
104,720

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: 560074
  • UDI-DI Primary/Individual Unit of Use: 04046964317873/04046964317859
  • Batch Numbers: 0061960383
  • 0061972565
  • 2. Material: 560214
  • UDI-DI Primary/Individual Unit of Use: 04046964318061/04046964318054
  • Batch Numbers: 0061971346
  • 0061977782
  • 3. Material: 560272
  • UDI-DI Primary/Individual Unit of Use: 04046964318108/04046964318085
  • Batch Numbers: 0061960367
  • 0061971330
  • 4. Material: 560327
  • UDI-DI Primary/Individual Unit of Use: 04046964318221/04046964318207
  • Batch Numbers: 0061960420
  • 0061977751
  • 5. Material: 560394
  • UDI-DI Primary/Individual Unit of Use: 04046964318429/04046964318405
  • Batch Numbers: 0061964747
  • 0061976985

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by B Braun Medical Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · B Braun Medical Inc

See all →

Same hazard · contained drug recall

See all →