FDAClass I · Medical device · Recalled June 3, 2026

Medline kits containing Huons Co recall — Medline Industries, LP

Hazard: 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: most serious — reasonable probability of serious health consequences or death.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2234-2026
Brand: Medline Industries
Classification: Class I
Units affected: 270 kits
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) BLOCK TRAY, Medline Kit SKU DYNJRA1181C; 2) SPINAL BLOCK 25G WHTCRE 5S BU, Medline Kit SKu DYNJRA1860.

Affected products

Medline kits containing Huons Co

Companies & origin

Recalling firm location: Northfield, IL, United States
Firm address: 3 Lakes Dr, 60093-2753

Identifying details (verbatim from the notice)

Product codes / lots: Medline Kit SKU DYNJRA1181C: UDI/DI 10193489457605 each, 40193489457606 case, Lot Number 25DMF105; Medline Kit SKU DYNJRA1181C: UDI/DI 10193489457605 each, 40193489457606 case, Lot Number 25CMB575; Medline Kit SKU DYNJRA1860: UDI/DI 10195327008413 each, 40195327008414 case, Lot Number 24DMB099.
Distribution: Worldwide - US Nationwide distribution in the US Territory of Virgin Islands and the countries of Bahamas, Panama, Barbados.
Firm notified the public via: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
FDA event ID: 98837
Recall initiated: April 10, 2026
FDA classified: May 28, 2026
FDA report date: June 3, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 3:00 AM UTC.

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