Z-3124-2026 Class I Ongoing
FDA device recall Z-3124-2026 was initiated by Medline Industries, LP on August 11, 2026 and is designated Class I. 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. Co… The recall status is ongoing. Affected quantity: 10407 kits.
Recall Details
- Product Type
- Devices
- Report Date
- September 23, 2026
- Initiation Date
- August 11, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10407 kits
Product Description
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 Pattern
US Nationwide distribution.
Code Information
1) ACC010308A, UDI-DI: 10889942424597(each), 40889942424598(case), Lot Number: 24HDA993; 2) ACC010308A, UDI-DI: 10889942424597(each), 40889942424598(case), Lot Number: 24IDB285; 3) ACC010308A, UDI-DI: 10889942424597(each), 40889942424598(case), Lot Number: 24JDA212; 4) ACC010374A, UDI-DI: 10193489893977(each), 40193489893978(case), Lot Number: 24IDB849; 5) ACC010679, UDI-DI: 10195327396268(each), 40195327396269(case), Lot Number: 24HDA071; 6) ACC010726A, UDI-DI: 10198459043666(each), 40198459043667(case), Lot Number: 24GDB143; 7) DYNDB3061, UDI-DI: 10889942143733(each), 40889942143734(case), Lot Number: 24HBS752; 8) DYNDH1245, UDI-DI: 10889942604722(each), 40889942604723(case), Lot Number: 24FMH385; 9) DYNDH1362, UDI-DI: 10888277797086(each), 40888277797087(case), Lot Number: 24HBQ828