FDA recall Z-3124-2026

Product

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

Reason for recall

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.

Distribution

US Nationwide distribution.

Key facts

Status

Ongoing

Initiation date

2026-08-11

Report date

2026-09-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Northfield, IL, United States

Primary source

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