This is part of a larger recall. The most authoritative record is FDA-Device / Z-2232-2026.

FDA-Device2026-06-03Class IPROCESSING DEFECT

Medline spinal anesthesia trays recalled for bupivacaine quality and efficacy concerns

OTHERNationwide distribution

Medline spinal trays recalled for bupivacaine quality issues

Medline distributed spinal anesthesia kits containing bupivacaine HCL in dextrose injection from Huons Co. that was recalled due to quality concerns. The underlying medication had issues with test data integrity and reports of reduced effectiveness.

  • Check your facility's inventory for the affected Medline kit SKUs (DYNJRA0245, DYNJRA0555, DYNJRA0836A, DYNJRA0978A, DYNJRA1034, DYNJRA9028, DYNJRA9030) and lot numbers listed in the FDA notice.
  • Do not use affected kits for spinal anesthesia procedures.
  • Contact Medline or your distributor for return or replacement instructions.
  • Review patient records if these kits were used and consult with your medical team if needed.
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.

Sold states
Worldwide - US Nationwide distribution in the US Territory of Virgin Islands and the countries of Bahamas, Panama, Barbados.
Affected count
41720 kits
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2233-2026

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