FDA-Device2026-09-23Class IPROCESSING DEFECT

Medline Convenience Kits recalled for fungal contamination in sterile applicators

Nationwide distributionMedical devices

What this means

Medline's Open Heart Adult, Full Line Aneurysm, and Non Sterile Chest Tube Removal convenience kits contain certain lots of sterile applicators that may be contaminated with Aspergillus penicillioides fungus. This fungus can grow under certain conditions and may cause serious infections including sepsis.

  • Check if you have one of the affected kits using the catalog and lot numbers provided
  • Do not use affected kits; contact Medline Industries or the FDA for return or disposal instructions
  • If a patient received a procedure using an affected kit, consult a healthcare provider about potential infection risk
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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
489 kits
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Medline Convenience Kits: 1) OPEN HEART ADULT, Catalog Number: CDS840396Y; 2) FULL LINE ANEURYSM CDS, Catalog Number: CDS983672O; 3) NON STERILE CHEST TUBE REMOVAL, Catalog Number: DYNDA1080

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3122-2026

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