CLASS I ONGOING Device recall · Reported 23 Sep 2026 · FDA Enforcement Report

Medline Convenience Kits recalled by Medline Industries

Medline Industries is recalling Medline Convenience Kits, distributed nationwide in the US. The recall was initiated on 11 Aug 2026 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codes1) DYKM1000B, UDI-DI: 10889942508143(each), 40889942508144(case), Lot Number: 24GMD979; 2) DYKM2187A, UDI-DI: 10195327628826(each), 40195327628827(case), Lot Number: 24FBM840; 3) DYKM2187A, UDI-DI: 10195327628826(each), 40195327628827(case), Lot Number: 24HBK903
Quantity recalled2718 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-3125-2026
FDA event ID
99669
Recalling firm
Medline Industries, Northfield, IL
Classification
Class I
Status
Ongoing
Recall initiated
11 Aug 2026
FDA classified
14 Sep 2026
Reported
23 Sep 2026
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Sterility

Timeline

11 Aug 2026Recall initiated by company
14 Sep 2026Classified by FDA+34 days
23 Sep 2026Published in enforcement report+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Medline Convenience Kits: 1) DYKM1000B, Catalog Number: DYKM1000B; 2) DYKM2187A, Catalog Number: DYKM2187A

Where it was distributed

US Nationwide distribution.

Nationwide

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

1) DYKM1000B, UDI-DI: 10889942508143(each), 40889942508144(case), Lot Number: 24GMD979; 2) DYKM2187A, UDI-DI: 10195327628826(each), 40195327628827(case), Lot Number: 24FBM840; 3) DYKM2187A, UDI-DI: 10195327628826(each), 40195327628827(case), Lot Number: 24HBK903

Where was it sold?

US Nationwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 29 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

6 other products · FDA event 99669
ReportedClassRecallCompanyReasonWhere
CLASS IMedline Convenience Kits: Kit Anesthesia L&d A- Line Set recalledMedline IndustriesSterilityNationwide
CLASS IMedline Convenience Kits recalled by Medline IndustriesMedline IndustriesSterilityNationwide
CLASS IMedline Convenience Kits: Open Heart Adult recalledMedline IndustriesSterilityNationwide
CLASS IMedline Convenience Kits recalled by Medline IndustriesMedline IndustriesSterilityNationwide
CLASS IMedline Convenience Kits recalled by Medline IndustriesMedline IndustriesSterilityNationwide
CLASS IMedline Convenience Kits: Port Access Kit Univ OF Ala recalledMedline IndustriesSterilityNationwide

More recalls from Medline Industries

All 698
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DeviceCLASS IMedline Convenience Kits: Port Access Kit Univ OF Ala recalledMedline IndustriesSterilityNationwide
DeviceCLASS IIConvenience kits Minor Pack DYNJ58421A Springhill Minor recalledMedline IndustriesSterilityNationwide
DeviceCLASS IMedline Convenience Kits recalled by Medline IndustriesMedline IndustriesSterilityNationwide
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