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FDAFDA · Food and drugs·Recall number Z-2237-2026

Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) SPINAL ANESTHESIA TRAY-LF, Medline Kit SKU DYNJRA0102A; 2) SPINAL TRAY-LF, Medline Kit SKU DYNJRA0143B; 3) SPINAL PREP TRAY-LF, Medline Kit SKU DYNJRA0205B; 4) SPINAL TRAY, Medline Kit SKU DYNJRA0255B; 5) SPINAL TRAY, Medline Kit SKU DYNJRA0320; 6) SPINAL TRAY, Medline Kit SKU DYNJRA0320A; 7) SPINAL BLOCK TRAY- LF, Medline Kit SKU DYNJRA0413C; 8) SPINAL TRAY, Medline Kit SKU DYNJRA0461D; 9) 25G SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA0945; 10) SPINAL TRAY, Medline Kit SKU DYNJRA1140B; 11) SPINAL TRAY, Medline Kit SKU DYNJRA1192; 12) SPINAL TRAY 25G, Medline Kit SKU DYNJRA1240; 13) TRAY, SPINAL PENCIL POINT 25G, Medline Kit SKU DYNJRA1288; 14) SPINAL 25G WHITACRE, Medline Kit SKU DYNJRA1301; 15) SPINAL BLOCK TRAY WHITACRE 24G, Medline Kit SKU DYNJRA1304; 16) AHN SPINAL TRAY, Medline Kit SKU DYNJRA1376; 17) SPINAL TRAY, Medline Kit SKU DYNJRA1477A; 18) ADULT SPINAL KIT, Medline Kit SKU DYNJRA1538; 19) SPINAL TRAY, Medline Kit SKU DYNJRA1558A; 20) SPINAL TRAY, Medline Kit SKU DYNJRA1560A; 21) SPINAL TRAY, Medline Kit SKU DYNJRA1565; 22) SPINAL ANESTHESIA TRAY, Medline Kit SKU DYNJRA1577C; 23) SPINAL NEEDLE TRAY, Medline Kit SKU DYNJRA1584; 24) 25G WHITACRE SPINAL TRAY, Medline Kit SKU DYNJRA1740A; 25) SPINAL TRAY, Medline Kit SKU DYNJRA1744A; 26) SPINAL TRAY, Medline Kit SKU DYNJRA1750A; 27) SPINAL TRAY, Medline Kit SKU DYNJRA1784; 28) SPINAL TRAY, Medline Kit SKU DYNJRA1790; 29) SPINAL TRAY, Medline Kit SKU DYNJRA1796; 30) MSSC SPINAL TRAY, Medline Kit SKU DYNJRA1802B; 31) SPINAL TRAY, Medline Kit SKU DYNJRA1818; 32) SPINAL TRAY, Medline Kit SKU DYNJRA1839; 33) SPINAL TRAY, Medline Kit SKU DYNJRA1884; 34) SPINAL TRAY, Medline Kit SKU DYNJRA1884A; 35) 24G SPINAL KIT, Medline Kit SKU DYNJRA1889; 36) SPINAL TRAY, Medline Kit SKU DYNJRA1929; 37) SPINAL TRAY, Medline Kit SKU DYNJRA1969; 38) SPINAL TRAY, Medline Kit SKU DYNJRA1982; 39) SPINAL TRAY/PENCAN, Medline Kit SKU DYNJRA1983A; 40) SPINAL NEEDLE TRAY, Medline Kit SKU DYNJRA1987; 41) SPINAL TRAY - 3 ML CHLORAPREP, Medline Kit SKU DYNJRA2005; 42) SPINAL TRAY, Medline Kit SKU DYNJRA2023; 43) SPINAL TRAY, Medline Kit SKU DYNJRA2068A; 44) SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA2088; 45) 25G WHITACRE SPINAL TRAY, Medline Kit SKU DYNJRA2115; 46) SPINAL BLOCK 25G WHTCRE 5S BU, Medline Kit SKU DYNJRA2117; 47) SPINAL TRAY, Medline Kit SKU DYNJRA2140; 48) SPINAL TRAY, Medline Kit SKU DYNJRA2153; 49) SPINAL BLOCK TRAY WHITACRE 24G, Medline Kit SKU DYNJRA2213; 50) SPINAL TRAY, Medline Kit SKU DYNJRA2225; 51) OR SPINAL BLOCK KIT, Medline Kit SKU DYNJRA2349; 52) SPINAL TRAY, Medline Kit SKU DYNJRA2360; 53) L&D SPINAL TRAY, Medline Kit SKU DYNJRA2371; 54) TRAY, 25G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2381; 55) SPINAL TRAY, Medline Kit SKU DYNJRA2432A; 56) OB SPINAL TRAY, Medline Kit SKU DYNJRA2532; 57) SPINAL TRAY, Medline Kit SKU DYNJRA2534; 58) SPINAL TRAY, Medline Kit SKU DYNJRA2556; 59) SPINAL TRAY, Medline Kit SKU DYNJRA2566A; 60) SPINAL TRAY BRAUN, Medline Kit SKU DYNJRA2575; 61) SPINAL TRAY, Medline Kit SKU DYNJRA2592; 62) SPINAL TRAY, Medline Kit SKU DYNJRA2597; 63) SPINAL BLOCK, Medline Kit SKU DYNJRA2605; 64) SPINAL TRAY, Medline Kit SKU DYNJRA2606; 65) SPINAL TRAY, Medline Kit SKU DYNJRA2607; 66) SPINAL TRAY, Medline Kit SKU DYNJRA2607A; 67) SPINAL TRAY, Medline Kit SKU DYNJRA2611; 68) SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA2613; 69) SPINAL TRAY, Medline Kit SKU DYNJRA2618A; 70) SPINAL TRAY, Medline Kit SKU DYNJRA2634; 71) SPINAL TRAY, Medline Kit SKU DYNJRA2638; 72) SPINAL TRAY, Medline Kit SKU DYNJRA2639; 73) JOI SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA2641; 74) SPINAL TRAY, Medline Kit SKU DYNJRA2653; 75) SPINAL BLOCK 25G WHTCRE 5S BU, Medline Kit SKU DYNJRA2669; 76) SPINAL TRAY, Medline Kit SKU DYNJRA2670; 77) SPINAL BLOCK TRAY 18G INTRO, Medline Kit SKU DYNJRA2672; 78) SPINAL TRAY 24G, Medline Kit

Published June 3, 2026 · Recall initiated: April 10, 2026

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the 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.

What to do

Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recall details

Manufacturer
Medline Industries, LP
Distributor
Worldwide - US Nationwide distribution in the US Territory of Virgin Islands and the countries of Bahamas, Panama, Barbados.
Lot
Medline Kit SKU DYNJRA0102A: UDI/DI 10884389459003 each, 40884389459004 case, Lot Number 26ABG838; Medline Kit SKU DYNJRA0102A: UDI/DI 10884389459003 each, 40884389459004 case, Lot Number 25JBR222; Medline Kit SKU DYNJRA0102A: UDI/DI 10884389459003 each, 40884389459004 case, Lot Number 25IBJ307; Medline Kit SKU DYNJRA0102A: UDI/DI 10884389459003 each, 40884389459004 case, Lot Number 25EBR346; Medline Kit SKU DYNJRA0102A: UDI/DI 10884389459003 each, 40884389459004 case, Lot Number 24LDB145; Medline Kit SKU DYNJRA0102A: UDI/DI 10884389459003 each, 40884389459004 case, Lot Number 24FDB896; Medline Kit SKU DYNJRA0143B: UDI/DI 10195327125820 each, 40195327125821 case, Lot Number 24ABQ670; Medline Kit SKU DYNJRA0205B: UDI/DI 10195327472344 each, 40195327472345 case, Lot Number 24KMD212; Medline Kit SKU DYNJRA0255B: UDI/DI 10195327282042 each, 40195327282043 case, Lot Number 26CMG585; Medline Kit SKU DYNJRA0255B: UDI/DI 10195327282042 each, 40195327282043 case, Lot Number 26BMK211; Medline Kit SKU DYNJRA0255B: UDI/DI 10195327282042 each, 40195327282043 case, Lot Number 25JMC385; Medline Kit SKU DYNJRA0255B: UDI/DI 10195327282042 each, 40195327282043 case, Lot Number 25IMB105; Medline Kit SKU DYNJRA0255B: UDI/DI 10195327282042 each, 40195327282043 case, Lot Number 25EMC687; Medline Kit SKU DYNJRA0255B: UDI/DI 10195327282042 each, 40195327282043 case, Lot Number 24HMD675; Medline Kit SKU DYNJRA0255B: UDI/DI 10195327282042 each, 40195327282043 case, Lot Number 24HMB249; Medline Kit SKU DYNJRA0255B: UDI/DI 10195327282042 each, 40195327282043 case, Lot Number 24GMH436; Medline Kit SKU DYNJRA0320: UDI/DI 10884389656778 each, 40884389656779 case, Lot Number 24EDB314; Medline Kit SKU DYNJRA0320: UDI/DI 10884389656778 each, 40884389656779 case, Lot Number 24BDA550; Medline Kit SKU DYNJRA0320A: UDI/DI 10198459027796 each, 40198459027797 case, Lot Number 26ABJ309; Medline Kit SKU DYNJRA0320A: UDI/DI 10198459027796 each, 40198459027797 case, Lot Number 25HBT750; Medline Kit SKU DYNJRA0320A: UDI/DI 10198459027796 each, 40198459027797 case, Lot Number 25GBW261; Medline Kit SKU DYNJRA0320A: UDI/DI 10198459027796 each, 40198459027797 case, Lot Number 25FBP025; Medline Kit SKU DYNJRA0413C: UDI/DI 10195327253363 each, 40195327253364 case, Lot Number 26AMK323; Medline Kit SKU DYNJRA0413C: UDI/DI 10195327253363 each, 40195327253364 case, Lot Number 25HMB655; Medline Kit SKU DYNJRA0413C: UDI/DI 10195327253363 each, 40195327253364 case, Lot Number 25FMF763; Medline Kit SKU DYNJRA0413C: UDI/DI 10195327253363 each, 40195327253364 case, Lot Number 24KMF380; Medline Kit SKU DYNJRA0413C: UDI/DI 10195327253363 each, 40195327253364 case, Lot Number 24KMA760; Medline Kit SKU DYNJRA0413C: UDI/DI 10195327253363 each, 40195327253364 case, Lot Number 23IBH412; Medline Kit SKU DYNJRA0461D: UDI/DI 10195327120689 each, 40195327120680 case, Lot Number 24KME483; Medline Kit SKU DYNJRA0461D: UDI/DI 10195327120689 each, 40195327120680 case, Lot Number 23KMD757; Medline Kit SKU DYNJRA0945: UDI/DI 10889942598267 each, 40889942598268 case, Lot Number 26BBP431; Medline Kit SKU DYNJRA0945: UDI/DI 10889942598267 each, 40889942598268 case, Lot Number 25KBN750; Medline Kit SKU DYNJRA0945: UDI/DI 10889942598267 each, 40889942598268 case, Lot Number 25IBK141; Medline Kit SKU DYNJRA0945: UDI/DI 10889942598267 each, 40889942598268 case, Lot Number 25EBG343; Medline Kit SKU DYNJRA0945: UDI/DI 10889942598267 each, 40889942598268 case, Lot Number 25ADA288; Medline Kit SKU DYNJRA0945: UDI/DI 10889942598267 each, 40889942598268 case, Lot Number 24FDA636; Medline Kit SKU DYNJRA1140B: UDI/DI 10193489432015 each, 40193489432016 case, Lot Number 26BMI341; Medline Kit SKU DYNJRA1140B: UDI/DI 10193489432015 each, 40193489432016 case, Lot Number 25LMF246; Medline Kit SKU DYNJRA1140B: UDI/DI 10193489432015 each, 40193489432016 case, Lot Number 25JMA359; Medline Kit SKU DYNJRA1140B: UDI/DI 10193489432015 each, 40193489432
Risk classification
Class I
Area (FDA)
device
Country
United States

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