Recall Z-2231-2026— Medline Industries, LP

Name: FDA recall Z-2231-2026
Creator: U.S. Food and Drug Administration
Published: 2026-04-10

Class I · Ongoing

Class I FDA medical device recall by Medline Industries, LP, initiated 2026-04-10. FDA's recall record names no specific 510(k) clearance for this event. 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..

Recalling firm: Medline Industries, LP
Classification: Class I
Status: Ongoing
Initiated: 2026-04-10
Firm location: Northfield, IL, United States

Product description

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 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.