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.

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 Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 26BBJ392; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 26ABS354; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 25LBC413; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 25IBK142; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 25FBD584; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 25BBK828; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 24FBT398; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 24BBR608; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 23JBB581; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 23IBQ010; Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each, 40889942879237 case, Lot Number 23HBM569; Medline Kit SKU DYNJRA1154: UDI/DI 10889942935864 each, 40889942935865 case, Lot Number 26AMK346; Medline Kit SKU DYNJRA1154: UDI/DI 10889942935864 each, 40889942935865 case, Lot Number 25KMG102; Medline Kit SKU DYNJRA1154: UDI/DI 10889942935864 each, 40889942935865 case, Lot Number 25JMA641; Medline Kit SKU DYNJRA1154: UDI/DI 10889942935864 each, 40889942935865 case, Lot Number 25GMC349; Medline Kit SKU DYNJRA1154: UDI/DI 10889942935864 each, 40889942935865 case, Lot Number 25DMG474; Medline Kit SKU DYNJRA1154: UDI/DI 10889942935864 each, 40889942935865 case, Lot Number 25DMC357; Medline Kit SKU DYNJRA1154: UDI/DI 10889942935864 each, 40889942935865 case, Lot Number 25ADB659; Medline Kit SKU DYNJRA1154: UDI/DI 10889942935864 each, 40889942935865 case, Lot Number 24LDB606; Medline Kit SKU DYNJRA1154: UDI/DI 10889942935864 each, 40889942935865 case, Lot Number 24KDB682; Medline Kit SKU DYNJRA1154: UDI/DI 10889942935864 each, 40889942935865 case, Lot Number 24JDC049; Medline Kit SKU DYNJRA1154: UDI/DI 10889942935864 each, 40889942935865 case, Lot Number 24FDA638; Medline Kit SKU DYNJRA1154: UDI/DI 10889942935864 each, 40889942935865 case, Lot Number 23JDC468; Medline Kit SKU DYNJRA1192A: UDI/DI 10198459155666 each, 40198459155667 case, Lot Number 26BBJ394; Medline Kit SKU DYNJRA1192A: UDI/DI 10198459155666 each, 40198459155667 case, Lot Number 25LBR313; Medline Kit SKU DYNJRA1192A: UDI/DI 10198459155666 each, 40198459155667 case, Lot Number 25KBP760; Medline Kit SKU DYNJRA1192A: UDI/DI 10198459155666 each, 40198459155667 case, Lot Number 25JBV827; Medline Kit SKU DYNJRA1192A: UDI/DI 10198459155666 each, 40198459155667 case, Lot Number 25JBG134; Medline Kit SKU DYNJRA1192A: UDI/DI 10198459155666 each, 40198459155667 case, Lot Number 25HBK390; Medline Kit SKU DYNJRA1192A: UDI/DI 10198459155666 each, 40198459155667 case, Lot Number 25DBF619; Medline Kit SKU DYNJRA1212: UDI/DI 10888277789838 each, 40888277789839 case, Lot Number 26BBT340; Medline Kit SKU DYNJRA1212: UDI/DI 10888277789838 each, 40888277789839 case, Lot Number 26ABU446; Medline Kit SKU DYNJRA1212: UDI/DI 10888277789838 each, 40888277789839 case, Lot Number 25JBE914; Medline Kit SKU DYNJRA1212: UDI/DI 10888277789838 each, 40888277789839 case, Lot Number 25GBT022; Medline Kit SKU DYNJRA1212: UDI/DI 10888277789838 each, 40888277789839 case, Lot Number 25EBS286; Medline Kit SKU DYNJRA1212: UDI/DI 10888277789838 each, 40888277789839 case, Lot Number 25DBJ529; Medline Kit SKU DYNJRA1212: UDI/DI 10888277789838 each, 40888277789839 case, Lot Number 25ADA237; Medline Kit SKU DYNJRA1212: UDI/DI 10888277789838 each, 40888277789839 case, Lot Number 24JDB280; Medline Kit SKU DYNJRA1212: UDI/DI 10888277789838 each, 40888277789839 case, Lot Number 24FDA639; Medline Kit SKU DYNJRA1212: UDI/DI 10888277789838 each, 40888277789839 case, Lot Number 24ED
Units affected: 30120 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-2236-2026
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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