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CriticalRecall #Z-2236-2026Medical Device

Medline Industries Recalls Medline kits containing Huons Co

Medline Industries, LP · Class I — Most Serious

Hospital operating room medical equipment — representative photo for FDA medical device recall
A hospital operating room with medical equipment (representative file photo). Specific recalled device: see recall details below. Photo: FDA / Public Domain.

Product Description

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 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.

FDA Classification

Class I — Most Serious

A situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.

Distribution

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

Remedy

Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.

411 Press Analysis

A Class I recall — the FDA's most urgent classification — has been issued for a medical device recalled by Medline Industries, LP on April 10, 2026. 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. This recall affects 30120 kits and was distributed internationally, including the United States. Class I recalls indicate a reasonable probability of serious health consequences or death. Consumers should stop using this product immediately.

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