This is part of a larger recall. The most authoritative record is FDA-Device / Z-2232-2026.
Medline anesthesia and spinal anesthesia trays recalled for bupivacaine quality issues
What this means
Medline distributed anesthesia and spinal anesthesia trays containing bupivacaine hydrochloride in dextrose injection that was recalled by the supplier due to quality issues. The concerns include problems with microbiology testing data and reports that the medication may not work as expected.
- If you have received or are using any of the affected Medline anesthesia trays (SKU DYNJRA1355A or DYNJRA2151), contact Medline to verify if your lot is affected.
- Do not use affected kits for patient procedures until you confirm with Medline or your supplier that your lot is not involved in the recall.
- Healthcare facilities should review their inventory against the lot numbers listed in the recall notice.
The agency's original wording
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2231-2026More Medline recalls
- FDA-PR2026-08-05Medline Hudson RCI Neonatal/Infant Heated Wire Breathing Circuits recalled for connector overheating risk
- FDA-Device2026-07-29Medline surgical convenience kits recalled for quality issues in anesthetic component
- FDA-Device2026-07-29Medline NEURO PACK medical kits recalled for Bacillus contamination
- FDA-Device2026-07-29Medline convenience kits with Bard Silastic Foley Catheters recalled for surface contamination
- FDA-Device2026-07-29Medline convenience kits with Bard Silastic Foley Catheters recalled for surface contamination
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