Recall Ledger

Medline Convenience Kits: 1) ACC010308A recall (Medline Industries, LP)

Medical deviceClass IOngoing

Summary: Medline Industries, LP is recalling 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) DYNDH1. Reason: 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.

What is being recalled

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

Why

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.

How serious is it

Class I is the most serious level: FDA considers there is a reasonable probability that using or being exposed to this product will cause serious health problems or death.

Where it was sold

US Nationwide distribution.

How to tell if yours is affected

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

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

Recall numberZ-3124-2026
CategoryMedical device
AgencyU.S. Food and Drug Administration (FDA)
SeverityClass I
StatusOngoing
Recall startedAugust 11, 2026
ReportedSeptember 23, 2026
CompanyMedline Industries, LP
Company locationNorthfield, IL, United States
Initiated byVoluntary: Firm initiated
Quantity10407 kits

More recalls from Medline Industries, LP · all medical device recalls · recalls from August 2026

Official FDA record