The Recall Desk
CriticalFDA (Devices)·Z-3125-2026·Announced 2026-09-23

Medline Convenience Kits Recalled for Fungal Contamination Risk

Medline Industries is recalling specific lots of Convenience Kits due to potential fungal contamination that could lead to serious adverse health consequences.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The source text explicitly states that the contamination may lead to serious adverse health consequences, including death, which meets the rubric criteria for a Critical severity score.

Plain-English summary

Medline Industries, LP is recalling 2,718 units of Medline Convenience Kits, specifically catalog numbers DYKM1000B and DYKM2187A. The recall covers kits distributed nationwide in the United States.

The recall is being issued because the kits contain certain lots of sterile applicators that may be contaminated with Aspergillus penicillioides. This fungal contamination may occur under certain environmental conditions. The source text states that contamination of skin preparation products with this fungus may lead to serious adverse health consequences, including systemic infection, sepsis, illness, and death.

Consumers who have these specific kits should stop using them and contact Medline Industries for further instructions. The affected lots are identified by the following UDI-DI and Lot Numbers: DYKM1000B (UDI-DI: 10889942508143, Lot 24GMD979); DYKM2187A (UDI-DI: 10195327628826, Lot 24FBM840); and DYKM2187A (UDI-DI: 10195327628826, Lot 24HBK903).

The recalled product

Product
Medline Convenience Kits: 1) DYKM1000B, Catalog Number: DYKM1000B; 2) DYKM2187A, Catalog Number: DYKM2187A
Affected units
2,718

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (10)

  • 1) DYKM1000B
  • UDI-DI: 10889942508143(each)
  • 40889942508144(case)
  • Lot Number: 24GMD979
  • 2) DYKM2187A
  • UDI-DI: 10195327628826(each)
  • 40195327628827(case)
  • Lot Number: 24FBM840
  • 3) DYKM2187A
  • Lot Number: 24HBK903

Distribution

Distributed nationwide across the United States.

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