Medical device recalls High risk

Medline Industries, LP recalls Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) SPINAL BLOCK TRAY, Medline…

Recall date
April 10, 2026
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2236-2026
FDA classification
Class I
Brand / firm
Medline Industries, LP
Sold / distributed
Worldwide - US Nationwide distribution in the US Territory of Virgin Islands and the countries of Bahamas, Panama, Barbados.

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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.

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