FDA-Device2026-09-23Class IPROCESSING DEFECT

Medline anesthesia L&D kits recalled for fungal contamination risk

OTHERNationwide distributionMedical devices

What this means

Certain lots of sterile applicators in Medline's Anesthesia L&D A-Line Set kits may contain Aspergillus penicillioides fungal contamination. This fungus can grow under certain environmental conditions and contaminate skin preparation products, potentially causing serious infections including sepsis.

  • Check if you have the affected kits (Catalog Number DYKMBNDL199A, Lot Numbers 24HBH109, 24HBM182, or 24HBS365).
  • Do not use affected kits.
  • Contact Medline Industries for instructions on return or replacement.
  • Review FDA's full recall notice for complete lot and UDI information.
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The agency's original wording
Hazard

The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences, including systemic infection, sepsis, illness, and death.

Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
12 kits
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Medline Convenience Kits: 1) KIT ANESTHESIA L&D A- LINE SET, Catalog Number: DYKMBNDL199A

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3121-2026

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