Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) SPINAL TRAY W/PENCIL POINT NDL, Medline Kit SKU DYNJRA0245; 2) SPINAL TRAY W/PENCIL POINT NDL, Medline Kit SKU DYNJRA0555; 3) SPINAL TRAY, Medline Kit SKU DYNJRA0836A; 4) SPINAL TRAY, Medline Kit SKU DYNJRA0978A; 5) TRAY, SPINAL, WHIT 24GX4, Medline Kit SKU DYNJRA1034; 6) SPINAL BLOCK 25G WHTCRE 5S BU, Medline Kit SKU DYNJRA9028; 7) TRAY, SPINAL PENCIL POINT 25G, Medline Kit SKU DYNJRA9030.

Class I

Recalling firm: Medline Industries, LP
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.
Affected products (lot / model / serial): Medline SKU DYNJRA0245: UDI/DI 10884389573488 each, 40884389573489 case, Lot Number 26AMH714; Medline SKU DYNJRA0245: UDI/DI 10884389573488 each, 40884389573489 case, Lot Number 26AMF179; Medline SKU DYNJRA0245: UDI/DI 10884389573488 each, 40884389573489 case, Lot Number 25IMI476; Medline SKU DYNJRA0245: UDI/DI 10884389573488 each, 40884389573489 case, Lot Number 25GME934; Medline SKU DYNJRA0245: UDI/DI 10884389573488 each, 40884389573489 case, Lot Number 24JMA156; Medline SKU DYNJRA0245: UDI/DI 10884389573488 each, 40884389573489 case, Lot Number 24IMG162; Medline SKU DYNJRA0245: UDI/DI 10884389573488 each, 40884389573489 case, Lot Number 23IBG784; Medline SKU DYNJRA0245: UDI/DI 10884389573488 each, 40884389573489 case, Lot Number 23HBG512; Medline SKU DYNJRA0245: UDI/DI 10884389573488 each, 40884389573489 case, Lot Number 23HBA325; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 26AMK307; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 25LME383; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 25JMJ632; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 25IMI508; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 25IMB093; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 25GMB270; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 25EMD040; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 25EMB958; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 24HMD548; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 24HMA551; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 24GMI471; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 24DBA515; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 24BBQ043; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 23IBH382; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 23GBD403; Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 26BMH362; Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 25LMC760; Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 25JME361; Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 25IMI413; Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 25HMH140; Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 25HMA304; Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 25GMB268; Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 25FMF696; Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 25DMJ266; Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 24HMB245; Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 24HMB241; Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 24GMB114; Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 24BME560; Medline SKU DYNJRA0978A: UDI/DI 10889942826827 each, 40889942826828 case, Lot Number 25KMD376; Medline SKU DYNJRA0978A: UDI/DI 10889942826827 each, 40889942826828 case, Lot Number 25JMC383; Medline SKU DYNJRA0978A: UDI/DI 10889942826827 each, 40889942826828 case, Lot Number 25FMH538; Medline SKU DYNJRA0978A: UDI/DI 10889942826827 each, 40889942826828 case, Lot Number 24KDB290; Medline SKU DYNJRA0978A: UDI/DI 10889942826827
Units affected: 41720 kits
Distribution pattern: Worldwide - US Nationwide distribution in the US Territory of Virgin Islands and the countries of Bahamas, Panama, Barbados.
Firm location: Northfield, IL, United States
Recall type: Voluntary: Firm initiated
How the firm notified customers: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product type: Devices
Status: Ongoing
Recall number: Z-2233-2026
Recall initiated: April 10, 2026
FDA classification date: May 28, 2026
FDA report date: June 3, 2026
FDA event ID: 98837
Last updated on HTM Vibe: July 24, 2026

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