# FDA recall Z-2231-2026

> **Medline Industries, LP** · Class I · device recall initiated 2026-04-10.

## Product

Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as:    1) ANESTHESIA TRAY, Medline SKU DYNJRA1355A;   2) SPINAL ANESTHESIA TRAY, Medline SKU DYNJRA2151.

## Reason for recall

Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.

## Distribution

Worldwide - US Nationwide distribution in the US Territory of Virgin Islands and the countries of Bahamas, Panama, Barbados.

## Key facts

- **Recall number:** Z-2231-2026
- **Recalling firm:** Medline Industries, LP
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-04-10
- **Report date:** 2026-06-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Northfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2231-2026

## Citation

> MORVS. FDA recall Z-2231-2026. Retrieved 2026-10-19 from https://api.morvs.ai/recall/Z-2231-2026. Source: US FDA. Licensed CC0.

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