Medline Industries, LP: 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

Recall number

Z-3124-2026

Recalling firm

Medline Industries, LP

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

Status

Open, Classified

Initiated

2026-08-11

Posted

2026-09-14

Terminated

not on file

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.

Root cause

Nonconforming Material/Component

Action

An URGENT MEDICAL DEVICE RECALL notification letter dated 8/11/26 was sent to customers. This communication serves as an update to the Medline notification sent on June 12, 2026. Please be advised that the actions required for certain item(s) and lot(s) identified in the original notification have changed based on additional recall details received from BD (Becton, Dickinson and Company). REQUIRED ACTION: 1.Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. Upon completion of the below actions, please destroy affected product. 2.Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the response form. Website link: https://recalls.medline.com Recall Reference #: R-26-097-FGX3 Recall Code: 3.Your account will receive credit once the response form is submitted. 4.If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please request that customers destroy any affected product. You should include your customers quantities on your response form. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.

Quantity

10407 kits

Distribution

US Nationwide distribution.

Lot, serial or model codes

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

510(k) numbers

not on file

PMA numbers

not on file

Product code

LRO

Firm FEI

1417592

Firm city

Northfield

Firm state

IL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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