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) SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA1097; 2) TRAY, SPINAL PENCIL POINT 25G, Medline Kit SKU DYNJRA1154; 3) SPINAL TRAY, Medline Kit SKU DYNJRA1192A; 4) BLOCK TRAY, Medline Kit SKU DYNJRA1212; 5) SPINAL NEEDLE TRAY, Medline Kit SKU DYNJRA1285; 6) SPINAL BLOCK TRAY WHITACRE 24G, Medline Kit SKU DYNJRA9031; 7) SPINAL BLOCK TRAY 25G WHITACRE, Medline Kit SKU DYNJRA9032; 8) 25G SPINAL TRAY, Medline Kit SKU PAIN1239.

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

30120 kits

Lot / codes

Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 26BBJ392; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 26ABS354; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 25LBC413; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 25IBK142; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 25FBD584; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 25BBK828; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 24FBT398; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 24BBR608; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 23JBB581; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 23IBQ010; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 23HBM569; Medline Kit SKU DYNJRA1154: UDI/DI 10889942935864 each, 40889942935865 case, Lot Number 26AMK346; Medline Kit SKU DYNJRA1154: UDI/DI 10889942935864 each, 40889942935865 case, Lot Number 25KMG102; Medline Kit SKU DYNJRA1154: UDI/DI 10889942935864 each, 40889942935865 case, Lot Number 25JMA641; Medline Kit SKU DYNJRA1154: UDI/DI 10889942935864 each, 40889942935865 case, Lot Number 25GMC349;

Company location

Northfield, IL

Recall type

Voluntary: Firm initiated

Recall number

Z-2236-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2236-2026 in the FDA Enforcement Report. Also see FDA recall press releases.