This is part of a larger recall. The most authoritative record is FDA-Device / Z-2232-2026.
Medline spinal anesthesia trays recalled for bupivacaine quality and efficacy concerns
What this means
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.
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-2233-2026More 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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