FDA-Device2026-09-23Class IPROCESSING DEFECT

Medline Convenience Kits recalled for fungal contamination in sterile applicators

OTHERNationwide distributionMedical devices

What this means

Certain lots of sterile applicators in Medline Convenience Kits may contain a fungus called Aspergillus penicillioides. This fungus can grow under certain storage conditions and could cause serious infections if the contaminated applicators are used on skin.

  • Check if you have one of the affected kits by matching your catalog number and lot number to the FDA recall notice.
  • Do not use affected kits on patients or clients.
  • Contact Medline Industries or your supplier for instructions on returning or disposing of recalled kits.
  • Report any adverse effects or infections potentially linked to these kits to the FDA MedWatch program.
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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
47848 kits
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Medline Convenience Kits: 1) DYNDB3086D, Catalog Number: DYNDB3086D; 2) DYNDB3100, Catalog Number: DYNDB3100; 3) DYNDH1619A, Catalog Number: DYNDH1619A; 4) DYNDH1620A, Catalog Number: DYNDH1620A; 5) DYNDH1694A, Catalog Number: DYNDH1694A; 6) DYNDH1695, Catalog Number: DYNDH1695; 7) DYNDH1708A, Catalog Number: DYNDH1708A; 8) DYNDH1714A, Catalog Number: DYNDH1714A; 9) DYNDH1723, Catalog Number: DYNDH1723; 10) DYNDH1740B, Catalog Number: DYNDH1740B; 11) DYNDH1741B, Catalog Number: DYNDH1741B; 12) DYNDH1771A, Catalog Number: DYNDH1771A; 13) DYNDH1908, Catalog Number: DYNDH1908; 14) DYNDH1940, Catalog Number: DYNDH1940; 15) DYNDH1988, Catalog Number: DYNDH1988; 16) DYNDH2002, Catalog Number: DYNDH2002; 17) DYNDH2017, Catalog Number: DYNDH2017. Blood and urine collection kits

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3127-2026

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