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 - DangerousWhat Should You Do?
- Check if you have this product: 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 24EDB329; Medline Kit SKU DYNJRA1212: UDI/DI 10888277789838 each, 40888277789839 case, Lot Number 24DDB935; Medline Kit SKU DYNJRA1212: UDI/DI 10888277789838 each, 40888277789839 case, Lot Number 24BDA655; Medline Kit SKU DYNJRA1285: UDI/DI 10193489566123 each, 40193489566124 case, Lot Number 26ABG845; Medline Kit SKU DYNJRA1285: UDI/DI 10193489566123 each, 40193489566124 case, Lot Number 25LBI115; Medline Kit SKU DYNJRA1285: UDI/DI 10193489566123 each, 40193489566124 case, Lot Number 25IBP109; Medline Kit SKU DYNJRA1285: UDI/DI 10193489566123 each, 40193489566124 case, Lot Number 25EBE523; Medline Kit SKU DYNJRA1285: UDI/DI 10193489566123 each, 40193489566124 case, Lot Number 24LDA129; Medline Kit SKU DYNJRA1285: UDI/DI 10193489566123 each, 40193489566124 case, Lot Number 24KDB674; Medline Kit SKU DYNJRA1285: UDI/DI 10193489566123 each, 40193489566124 case, Lot Number 24FDA633; Medline Kit SKU DYNJRA1285: UDI/DI 10193489566123 each, 40193489566124 case, Lot Number 23JDC158; Medline Kit SKU DYNJRA9031: UDI/DI 10889942802289 each, 40889942802280 case, Lot Number 26ABC785; Medline Kit SKU DYNJRA9031: UDI/DI 10889942802289 each, 40889942802280 case, Lot Number 25LBH049; Medline Kit SKU DYNJRA9031: UDI/DI 10889942802289 each, 40889942802280 case, Lot Number 25KBK340; Medline Kit SKU DYNJRA9031: UDI/DI 10889942802289 each, 40889942802280 case, Lot Number 25BBH830; Medline Kit SKU DYNJRA9031: UDI/DI 10889942802289 each, 40889942802280 case, Lot Number 25BBF629; Medline Kit SKU DYNJRA9031: UDI/DI 10889942802289 each, 40889942802280 case, Lot Number 24GBD224; Medline Kit SKU DYNJRA9031: UDI/DI 10889942802289 each, 40889942802280 case, Lot Number 24FBJ060; Medline Kit SKU DYNJRA9031: UDI/DI 10889942802289 each, 40889942802280 case, Lot Number 23IBQ015; Medline Kit SKU DYNJRA9031: UDI/DI 10889942802289 each, 40889942802280 case, Lot Number 23HBR199; Medline Kit SKU DYNJRA9031: UDI/DI 10889942802289 each, 40889942802280 case, Lot Number 23GBR079; Medline Kit SKU DYNJRA9032: UDI/DI 10889942802272 each, 40889942802273 case, Lot Number 25KBJ715; Medline Kit SKU DYNJRA9032: UDI/DI 10889942802272 each, 40889942802273 case, Lot Number 25JBP382; Medline Kit SKU DYNJRA9032: UDI/DI 10889942802272 each, 40889942802273 case, Lot Number 25JBB437; Medline Kit SKU DYNJRA9032: UDI/DI 10889942802272 each, 40889942802273 case, Lot Number 25GBH340; Medline Kit SKU DYNJRA9032: UDI/DI 10889942802272 each, 40889942802273 case, Lot Number 25FBD726; Medline Kit SKU DYNJRA9032: UDI/DI 10889942802272 each, 40889942802273 case, Lot Number 25ABP028; Medline Kit SKU PAIN1239: UDI/DI 10889942873814 each, 40889942873815 case, Lot Number 26CBD939; Medline Kit SKU PAIN1239: UDI/DI 10889942873814 each, 40889942873815 case, Lot Number 26BBB061; Medline Kit SKU PAIN1239: UDI/DI 10889942873814 each, 40889942873815 case, Lot Number 25LBT244; Medline Kit SKU PAIN1239: UDI/DI 10889942873814 each, 40889942873815 case, Lot Number 25FBU644; Medline Kit SKU PAIN1239: UDI/DI 10889942873814 each, 40889942873815 case, Lot Number 24DLA279.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
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.
Product Codes/Lot Numbers:
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 24EDB329; Medline Kit SKU DYNJRA1212: UDI/DI 10888277789838 each, 40888277789839 case, Lot Number 24DDB935; Medline Kit SKU DYNJRA1212: UDI/DI 10888277789838 each, 40888277789839 case, Lot Number 24BDA655; Medline Kit SKU DYNJRA1285: UDI/DI 10193489566123 each, 40193489566124 case, Lot Number 26ABG845; Medline Kit SKU DYNJRA1285: UDI/DI 10193489566123 each, 40193489566124 case, Lot Number 25LBI115; Medline Kit SKU DYNJRA1285: UDI/DI 10193489566123 each, 40193489566124 case, Lot Number 25IBP109; Medline Kit SKU DYNJRA1285: UDI/DI 10193489566123 each, 40193489566124 case, Lot Number 25EBE523; Medline Kit SKU DYNJRA1285: UDI/DI 10193489566123 each, 40193489566124 case, Lot Number 24LDA129; Medline Kit SKU DYNJRA1285: UDI/DI 10193489566123 each, 40193489566124 case, Lot Number 24KDB674; Medline Kit SKU DYNJRA1285: UDI/DI 10193489566123 each, 40193489566124 case, Lot Number 24FDA633; Medline Kit SKU DYNJRA1285: UDI/DI 10193489566123 each, 40193489566124 case, Lot Number 23JDC158; Medline Kit SKU DYNJRA9031: UDI/DI 10889942802289 each, 40889942802280 case, Lot Number 26ABC785; Medline Kit SKU DYNJRA9031: UDI/DI 10889942802289 each, 40889942802280 case, Lot Number 25LBH049; Medline Kit SKU DYNJRA9031: UDI/DI 10889942802289 each, 40889942802280 case, Lot Number 25KBK340; Medline Kit SKU DYNJRA9031: UDI/DI 10889942802289 each, 40889942802280 case, Lot Number 25BBH830; Medline Kit SKU DYNJRA9031: UDI/DI 10889942802289 each, 40889942802280 case, Lot Number 25BBF629; Medline Kit SKU DYNJRA9031: UDI/DI 10889942802289 each, 40889942802280 case, Lot Number 24GBD224; Medline Kit SKU DYNJRA9031: UDI/DI 10889942802289 each, 40889942802280 case, Lot Number 24FBJ060; Medline Kit SKU DYNJRA9031: UDI/DI 10889942802289 each, 40889942802280 case, Lot Number 23IBQ015; Medline Kit SKU DYNJRA9031: UDI/DI 10889942802289 each, 40889942802280 case, Lot Number 23HBR199; Medline Kit SKU DYNJRA9031: UDI/DI 10889942802289 each, 40889942802280 case, Lot Number 23GBR079; Medline Kit SKU DYNJRA9032: UDI/DI 10889942802272 each, 40889942802273 case, Lot Number 25KBJ715; Medline Kit SKU DYNJRA9032: UDI/DI 10889942802272 each, 40889942802273 case, Lot Number 25JBP382; Medline Kit SKU DYNJRA9032: UDI/DI 10889942802272 each, 40889942802273 case, Lot Number 25JBB437; Medline Kit SKU DYNJRA9032: UDI/DI 10889942802272 each, 40889942802273 case, Lot Number 25GBH340; Medline Kit SKU DYNJRA9032: UDI/DI 10889942802272 each, 40889942802273 case, Lot Number 25FBD726; Medline Kit SKU DYNJRA9032: UDI/DI 10889942802272 each, 40889942802273 case, Lot Number 25ABP028; Medline Kit SKU PAIN1239: UDI/DI 10889942873814 each, 40889942873815 case, Lot Number 26CBD939; Medline Kit SKU PAIN1239: UDI/DI 10889942873814 each, 40889942873815 case, Lot Number 26BBB061; Medline Kit SKU PAIN1239: UDI/DI 10889942873814 each, 40889942873815 case, Lot Number 25LBT244; Medline Kit SKU PAIN1239: UDI/DI 10889942873814 each, 40889942873815 case, Lot Number 25FBU644; Medline Kit SKU PAIN1239: UDI/DI 10889942873814 each, 40889942873815 case, Lot Number 24DLA279.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2236-2026
Related Recalls
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.