# FDA recall Z-2278-2026

> **B Braun Medical Inc** · Class I · device recall initiated 2026-05-06.

## 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 (560428),  SSK L G H (ORIGINAL CUST) (560462),  SSK H M H (560465),  SSK BUPIVACAINE TRAY 2068824 (560476),  SSK K F H (560497),  SSK T J U H (560513),  SSK O M C (560521),  SSK CUSTOM SPINAL TRAY (560523),  SSK O R M C (560533),  SSK B S H S 20115122 (560538),  SSK M M (560572),  SSK M S 27GA PENCAN SPINAL TRAY (560580),  SSK S T H & C (560584),  SSK U C (560587), SSK P25BKG (560603),  SSK P24BKG (560606),  SSK S25BKG (560607),  SSK M C - BUPIVACAINE TRAY (560609),  SSK T M C (560613),  SSK PENCIL POINT SPINAL TRAY (560619),  SSK E O & S H-SPINAL (560621),  SSK BSW SPINAL TRAY (560628),  SSK M C OB DEPT - SPINAL (560645),  SSK B H M (560646),  SSK M G M C (560647),  SSK S M H (560648),  SSK H H S (560660),  O S U M C SPINAL TRAY SSK (560667),  A M C, SSK (560670),  S B H - SPINAL TRAY SSK (560672);

## Reason for recall

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.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-2278-2026
- **Recalling firm:** B Braun Medical Inc
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-05-06
- **Report date:** 2026-06-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bethlehem, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2278-2026

## Citation

> MORVS. FDA recall Z-2278-2026. Retrieved 2026-10-18 from https://api.morvs.ai/recall/Z-2278-2026. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*