Urgent site urgencyFDA Class I

Medline Convenience Kits: 1) ACC010308A, Catalog Number: ACC010308A

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.

Agency
FDA Device
Recall date
Aug 11, 2026
Status
Ongoing
Company
Medline Industries, LP

1. What product was recalled?

Medline Convenience Kits: 1) ACC010308A, Catalog Number: ACC010308A

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

Quantity: 10407 kits

Code or lot text: 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

LOT
1) ACC010308A
LOT
2) ACC010308A
LOT
3) ACC010308A
LOT
4) ACC010374A
LOT
40193489893978(case)
LOT
40195327396269(case)
LOT
40198459043667(case)
LOT
40888277797087(case)
LOT
40889942143734(case)
LOT
40889942424598(case)
LOT
40889942604723(case)
LOT
5) ACC010679
LOT
6) ACC010726A
LOT
7) DYNDB3061
LOT
8) DYNDH1245
LOT
9) DYNDH1362
LOT
Lot Number: 24FMH385
LOT
Lot Number: 24GDB143
LOT
Lot Number: 24HBQ828
LOT
Lot Number: 24HBS752
LOT
Lot Number: 24HDA071
LOT
Lot Number: 24HDA993
LOT
Lot Number: 24IDB285
LOT
Lot Number: 24IDB849
LOT
Lot Number: 24JDA212
LOT
UDI-DI: 10193489893977(each)
LOT
UDI-DI: 10195327396268(each)
LOT
UDI-DI: 10198459043666(each)
LOT
UDI-DI: 10888277797086(each)
LOT
UDI-DI: 10889942143733(each)
LOT
UDI-DI: 10889942424597(each)
LOT
UDI-DI: 10889942604722(each)
RECALL-NUMBER
Z-3124-2026

Medline Convenience Kits: 1) PORT ACCESS KIT UNIV OF ALA, Catalog Number: DYKM1414

Medline Convenience Kits: 1) PORT ACCESS KIT UNIV OF ALA, Catalog Number: DYKM1414; 2) ARTERIAL LINE ST JOES SYR PACK, Catalog Number: DYNJ38145F

Quantity: 447 kits

Code or lot text: 1) DYKM1414, UDI-DI: 10889942481293(each), 40889942481294(case), Lot Number: 24HBS933; 2) DYNJ38145F, UDI-DI: 10193489277173(each), 40193489277174(case), Lot Number: 24HBT600

LOT
1) DYKM1414
LOT
2) DYNJ38145F
LOT
40193489277174(case)
LOT
40889942481294(case)
LOT
Lot Number: 24HBS933
LOT
Lot Number: 24HBT600
LOT
UDI-DI: 10193489277173(each)
LOT
UDI-DI: 10889942481293(each)
RECALL-NUMBER
Z-3123-2026

2. Is my exact product affected?

Compare every printed identifier. A matching value can indicate that your product is included.

3. What is the 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.

4. What should I do now?

Follow the FDA recall notice and contact the recalling company for current instructions.

5. Where was it sold or distributed?

Nationwide

6. Were injuries or illnesses reported?

No separate injury or illness statement was present in the normalized record. Check the official source for the latest report.

7. What remedy is available?

Follow the FDA recall notice and contact the recalling company for current instructions.

8. Is the recall active or closed?

The source status is Ongoing. The Recall Guy's urgency label is urgent, which is a separate deterministic site label.

9. When was the information checked?

Last checked .

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10. Where is the official source?

Open the official FDA Device source

The Recall Guy normalizes public source data for easier checking. Source agencies remain authoritative. Confirm identifiers and instructions at the official source.