FDA-Device2026-09-23Class IPROCESSING DEFECT

Medline Convenience Kits recalled for fungal contamination risk in sterile applicators

Nationwide distributionMedical devices

What this means

Several lots of Medline Convenience Kits contain sterile applicators that may be contaminated with Aspergillus penicillioides, a fungus that can grow under certain conditions. If these kits are used on skin, the contamination could cause serious infection, including sepsis.

  • Check if you have one of the affected Convenience Kit models (ACC010308A, ACC010374A, ACC010679, ACC010726A, DYNDB3061, DYNDH1245, or DYNDH1362).
  • Verify the lot number on your kit against the FDA recall list.
  • Do not use affected kits for skin preparation.
  • Contact Medline or the FDA with questions about your specific lot.
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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
10407 kits
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Medline Convenience Kits: 1) ACC010308A, Catalog Number: ACC010308A; 2) ACC010374A, Catalog Number: ACC010374A; 3) ACC010679, Catalog Number: ACC010679; 4) ACC010726A, Catalog Number: ACC010726A; 5) DYNDB3061, Catalog Number: DYNDB3061; 6) DYNDH1245, Catalog Number: DYNDH1245; 7) DYNDH1362, Catalog Number: DYNDH1362

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3124-2026

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