RecallRadar
FDA · Medical devicesClass I

Medline Industries, LP medical device recall: Medline Convenience Kits: 1) KIT ANESTHESIA L&D A- LINE SET

LeadSterility concerns

Key facts

Agency
U.S. Food and Drug Administration (FDA)
Program
Medical devices
Classification
Class I
Status
Ongoing
Event ID
99669
Recall initiated
Aug 11, 2026
Classified by FDA
Sep 14, 2026
Posted in Enforcement Report
Sep 23, 2026
Recalling firm
Medline Industries, LP
Firm location
Northfield, IL, United States
Initiated by
Voluntary: Firm initiated
Firm notified customers by
Letter
Products in this event
7

What to do

Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.

View the official FDA record ↗

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.

What the classification means

  • Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.

About this recall

The firm started this recall on Aug 11, 2026. FDA classified it 34 days later, on Sep 14, 2026. This recall event covers 7 separate products, each with its own FDA recall number. Distribution reported by FDA: US Nationwide distribution. Medline Industries, LP has 257 recalls in our records.

Recalled products (7)

  • Z-3121-2026 Class I Ongoing

    Medline Convenience Kits: 1) KIT ANESTHESIA L&D A- LINE SET, Catalog Number: DYKMBNDL199A

    Codes / lots: 1) DYKMBNDL199A, UDI-DI: 10193489848540(each), 40193489848541(case), Lot Number: 24HBH109; 2) DYKMBNDL199A, UDI-DI: 10193489848540(each), 40193489848541(case), Lot Number: 24HBM182; 3) DYKMBNDL199A, UDI-DI: 10193489848540(each), 40193489848541(case), Lot Number: 24HBS365

    Quantity: 12 kits

  • Z-3122-2026 Class I Ongoing

    Medline Convenience Kits: 1) OPEN HEART ADULT, Catalog Number: CDS840396Y; 2) FULL LINE ANEURYSM CDS, Catalog Number: CDS983672O; 3) NON STERILE CHEST TUBE REMOVAL, Catalog Number: DYNDA1080

    Codes / lots: 1) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 24FBJ654; 2) CDS983672O, UDI-DI: 10195327207625(each), 40195327207626(case), Lot Number: 24FBM444; 3) CDS983672O, UDI-DI: 10195327207625(each), 40195327207626(case), Lot Number: 24HBJ581; 4) DYNDA1080, UDI-DI: 10884389388679(each), 40884389388670(case), Lot Number: 24HBT102

    Quantity: 489 kits

  • Z-3123-2026 Class I Ongoing

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

    Codes / lots: 1) DYKM1414, UDI-DI: 10889942481293(each), 40889942481294(case), Lot Number: 24HBS933; 2) DYNJ38145F, UDI-DI: 10193489277173(each), 40193489277174(case), Lot Number: 24HBT600

    Quantity: 447 kits

  • Z-3124-2026 Class I Ongoing

    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

    Codes / lots: 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

    Quantity: 10407 kits

  • Z-3125-2026 Class I Ongoing

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

    Codes / lots: 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

    Quantity: 2718 kits

  • Z-3126-2026 Class I Ongoing

    Medline Convenience Kits: 1) DYNDH1193, Catalog Number: DYNDH1193; 2) DYNDH1487A, Catalog Number: DYNDH1487A

    Codes / lots: 1) DYNDH1193, UDI-DI: 10889942499953(each), 40889942499954(case), Lot Number: 24HBF076; 2) DYNDH1193, UDI-DI: 10889942499953(each), 40889942499954(case), Lot Number: 24HBU638; 3) DYNDH1487A, UDI-DI: 10193489484311(each), 40193489484312(case), Lot Number: 24FMH485

    Quantity: 1100 kits

  • Z-3127-2026 Class I Ongoing

    Medline Convenience Kits: 1) DYNDB3086D, Catalog Number: DYNDB3086D; 2) DYNDB3100, Catalog Number: DYNDB3100; 3) DYNDH1619A, Catalog Number: DYNDH1619A; 4) DYNDH1620A, Catalog Number: DYNDH1620A; 5) DYNDH1694A, Catalog Number: DYNDH1694A; 6) DYNDH1695, Catalog Number: DYNDH1695; 7) DYNDH1708A, Catalog Number: DYNDH1708A; 8) DYNDH1714A, Catalog Number: DYNDH1714A; 9) DYNDH1723, Catalog Number: DYNDH1723; 10) DYNDH1740B, Catalog Number: DYNDH1740B; 11) DYNDH1741B, Catalog Number: DYNDH1741B; 12) DYNDH1771A, Catalog Number: DYNDH1771A; 13) DYNDH1908, Catalog Number: DYNDH1908; 14) DYNDH1940, Catalog Number: DYNDH1940; 15) DYNDH1988, Catalog Number: DYNDH1988; 16) DYNDH2002, Catalog Number: DYNDH2002; 17) DYNDH2017, Catalog Number: DYNDH2017. Blood and urine collection kits

    Codes / lots: 1) DYNDB3086D, UDI-DI: 10195327313234(each), 40195327313235(case), Lot Number: 24IBA685; 2) DYNDB3100, UDI-DI: 10198459028915(each), 40198459028916(case), Lot Number: 24IBF913; 3) DYNDH1619A, UDI-DI: 10195327215835(each), 40195327215836(case), Lot Number: 24FBH708; 4) DYNDH1619A, UDI-DI: 10195327215835(each), 40195327215836(case), Lot Number: 24HBG622; 5) DYNDH1620A, UDI-DI: 10195327216047(each), 40195327216048(case), Lot Number: 24GBY827; 6) DYNDH1620A, UDI-DI: 10195327216047(each), 40195327216048(case), Lot Number: 24HBQ593; 7) DYNDH1620A, UDI-DI: 10195327216047(each), 40195327216048(case), Lot Number: 24HBU881; 8) DYNDH1694A, UDI-DI: 10195327139957(each), 40195327139958(case), Lot Number: 24EBI901; 9) DYNDH1694A, UDI-DI: 10195327139957(each), 40195327139958(case), Lot Number: 24HBG834; 10) DYNDH1695, UDI-DI: 10195327113155(each), 40195327113156(case), Lot Number: 24FBQ907; 11)…

    Quantity: 47848 kits

Source and freshness

Source
U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
Official notice
FDA Enforcement Report, event 99669
Raw record
openFDA API (JSON)
Dataset last updated by FDA
Nov 3, 2026
Imported by RecallRadar
Nov 4, 2026

Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.

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