Medical device recalls High risk

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

Recall date
April 10, 2026
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2232-2026
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) PAIN TRAY, Medline Kit SKU DYNJRA1555; 2) SPINAL BLOCK TRAY WHITACRE 24G, Medline Kit SKU DYNJRA1817; 3) TRAY, 25G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA1920; 4) ULTRASOUND GUIDED NERVE BLOCK, Medline Kit SKU DYNJRA2013; 5) TRAY, 25G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2017; 6) 25G SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA2067; 7) 25G SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA2067A; 8) TRAY, 25G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2093; 9) SPINAL BLOCK 25G WHTCRE 5S BU, Medline Kit SKU DYNJRA2117A; 10) SPINAL BLOCK 25G WHTCRE 5S BU, Medline Kit SKU DYNJRA2124; 11) SPINAL BLOCK 25G WHTCRE 5S BU, Medline Kit SKU DYNJRA2124A; 12) PAIN TRAY, Medline Kit SKU DYNJRA2144; 13) TRAY, 24G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2221; 14) TRAY, SPINAL PENCIL POINT 25G, Medline Kit SKU DYNJRA2333; 15) SPINAL TRAY, Medline Kit SKU DYNJRA2390; 16) SPINAL BLOCK 25G WHTCRE 5S BU, Medline Kit SKU DYNJRA2402; 17) SPINAL ANESTHESIA TRAY, Medline Kit SKU DYNJRA2407; 18) SPINAL ANESTHESIA TRAY, Medline Kit SKU DYNJRA2407A; 19) SPINAL ANESTHESIA TRAY, Medline Kit SKU DYNJRA2407B; 20) TRAY, SPINAL PENCIL POINT 25G, Medline Kit SKU DYNJRA2447; 21) TRAY, SPINAL PENCIL POINT 25G, Medline Kit SKU DYNJRA2447A; 22) SPINAL TRAY 25G, Medline Kit SKU DYNJRA2488A; 23) J&S SPINAL TRAY, Medline Kit SKU DYNJRA2545; 24) SPINAL TRAY, Medline Kit SKU DYNJRA2549; 25) TRAY, 25G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2550; 26) TRAY, SPINAL PENCIL POINT 25G, Medline Kit SKU DYNJRA2552; 27) SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA2554; 28) SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA2554A; 29) SPINAL ANESTHESIA TRAY, Medline Kit SKU DYNJRA2578; 30) TRAY, 25G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2588; 31) TRAY, 25G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2602; 32) SPINAL TRAY, Medline Kit SKU DYNJRA2618; 33) SPINAL TRAY, Medline Kit SKU DYNJRA2619; 34) SPINAL TRAY, Medline Kit SKU DYNJRA2622; 35) SPINAL BLOCK 25 WHITACRE 5S ND, Medline Kit SKU DYNJRA2624; 36) SPINAL TRAY, Medline Kit SKU DYNJRA2631; 37) TRAY, SPINAL PENCIL POINT 25G, Medline Kit SKU DYNJRA2632; 38) TRAY, 25G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2633; 39) SPINAL TRAY, Medline Kit SKU DYNJRA2645; 40) TRAY, 25G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2654; 41) CSE PAIN MANAGEMENT TRAY, Medline Kit SKU DYNJRA2665; 42) SPINAL TRAY, Medline Kit SKU DYNJRA2667; 43) SPINAL TRAY 24G BD, Medline Kit SKU DYNJRA2675; 44) SPINAL TRAY W/ CHLORAPREP, Medline Kit SKU DYNJRA2680; 45) SPINAL TRAY, Medline Kit SKU DYNJRA2682; 46) TRAY, 24G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2684; 47) SPINAL TRAY, Medline Kit SKU DYNJRA2725; 48) 25G SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA2757; 49) TRAY, 25G SPINAL W/RX DURAPREP, Medline Kit SKU DYNJRA9039; 50) TRAY, 25G SPINAL W/RX, Medline Kit SKU DYNJRA9045; 51) SLSYSTEM CSE TRAY, Medline Kit SKU PAIN2333; 52) 25G SPINAL BLOCK TRAY, Medline Kit SKU SAMPA0135.

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