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 trays recalled for bupivacaine quality and efficacy concerns

OTHERNationwide distributionMedical devices

What this means

Medline distributed spinal block and needle trays containing bupivacaine injection from Huons Co. that was later recalled due to quality problems. The injectable anesthetic had concerns about microbiology testing data integrity and reported efficacy complaints.

  • Check the lot number on your spinal block kit against the FDA recall notice.
  • Do not use affected kits for spinal procedures.
  • Contact your Medline representative or the FDA for instructions on how to return or dispose of affected kits.
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
30120 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 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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2236-2026

More Medline recalls

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