FDA-Device2026-09-23Class IPROCESSING DEFECT

Medline Convenience Kits recalled for fungal contamination risk in sterile applicators

OTHERNationwide distributionMedical devices

What this means

Certain lots of sterile applicators in Medline Convenience Kits may be contaminated with Aspergillus penicillioides fungus. This fungus can grow under certain environmental conditions and may cause serious infections, including sepsis, if the contaminated applicators contact skin during preparation.

  • Check if you have Medline Convenience Kit models DYNDH1193 or DYNDH1487A with lot numbers 24HBF076, 24HBU638, or 24FMH485.
  • Do not use affected kits. Contact Medline or your supplier for instructions on return or disposal.
  • If you used an affected kit and develop signs of infection (fever, redness, swelling, or systemic illness), seek medical attention immediately and mention the potential fungal exposure.
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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
All ages
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
1100 kits
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Medline Convenience Kits: 1) DYNDH1193, Catalog Number: DYNDH1193; 2) DYNDH1487A, Catalog Number: DYNDH1487A

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3126-2026

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