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-Device2026-10-14Medline bariatric rollator recalled for front wheel detachment risk
- FDA-Device2026-10-14Medline bariatric rollator recalled for front wheel detachment risk causing fall hazard
- FDA-Device2026-10-07Medline Basic and Medlite homecare bed hand pendants recalled for fire hazard
- FDA-Device2026-09-30Medline neurological surgical kits recalled for elevated endotoxin levels in sponges
- FDA-Device2026-09-30Medline Convenience Kits Major Pack recalled for elevated endotoxin levels in neurological sponges
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