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

FDA-Device2026-06-03Class IPROCESSING DEFECT

Medline nerve block kits recalled for bupivacaine quality and efficacy concerns

OTHERNationwide distribution

Medline nerve block kits recalled for quality issues

Medline distributed medical kits containing bupivacaine injection that were later recalled by the manufacturer due to quality concerns. The injectable anesthetic had microbiology testing data integrity issues and some reports of reduced effectiveness. About 270 kits were affected.

  • If you use or manage these kits (SKU DYNJRA1181C or DYNJRA1860), stop use immediately
  • Contact Medline for instructions on the affected lot numbers (25DMF105, 25CMB575, or 24DMB099)
  • Review your inventory for the specific SKUs and lot numbers listed in the recall notice
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
270 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) BLOCK TRAY, Medline Kit SKU DYNJRA1181C; 2) SPINAL BLOCK 25G WHTCRE 5S BU, Medline Kit SKu DYNJRA1860.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2234-2026

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