Medline Industries, LP recalls Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection

Recalling company

Medline Industries, LP

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

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.

Classification

Class I – a reasonable probability that use will cause serious adverse health consequences or death

Recall date

Apr 10, 2026

Reported

Jun 3, 2026

Distribution

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

Status

Ongoing

Quantity

1100 kits

Lot / codes

Medline SKU DYNJRA1355A: UDI/DI 10195327179830 each, FI case, Lot Numbers: 26CBA272; Medline SKU DYNJRA1355A: UDI/DI 10195327179830 each, FI case, Lot Numbers: 26ABS307; Medline SKU DYNJRA1355A: UDI/DI 10195327179830 each, FI case, Lot Numbers: 25HBE663; Medline SKU DYNJRA1355A: UDI/DI 10195327179830 each, FI case, Lot Numbers: 25FBA408; Medline SKU DYNJRA1355A: UDI/DI 10195327179830 each, FI case, Lot Numbers: 25CBG043; Medline SKU DYNJRA1355A: UDI/DI 10195327179830 each, FI case, Lot Numbers: 24FBT395; Medline SKU DYNJRA2151: UDI/DI 10195327365400 each, FI case, Lot Numbers: 24FBT396.

Company location

Northfield, IL

Recall type

Voluntary: Firm initiated

Recall number

Z-2231-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2231-2026 in the FDA Enforcement Report. Also see FDA recall press releases.