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 block kits recalled for quality and microbiology testing integrity issues

OTHERNationwide distributionMedical devices

What this means

Medline distributed spinal anesthetic kits containing Bupivacaine Hydrochloride in Dextrose Injection that were recalled by the manufacturer due to quality issues. The problems include concerns about microbiology testing data integrity and reports that the medication may not work as intended.

  • If you received or used Medline Kit SKU DYNJRA9026 with lot numbers 26BBD235, 26ABB534, 25DBT837, 25CBH118, 24FBT403, or 24FBJ505, contact your healthcare provider or pharmacy immediately.
  • Do not use these kits for spinal procedures.
  • Return affected kits to your distributor or pharmacy.
The agency's original wording
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.

Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide - US Nationwide distribution in the US Territory of Virgin Islands and the countries of Bahamas, Panama, Barbados.
Affected count
4370 kits
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: SPINAL BLOCK 22G QUINCKE 5S BU, Medline Kit SKU DYNJRA9026

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2235-2026

More Medline recalls

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