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Medline Convenience Kits
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MEDICAL DEVICE RECALLMODERATE

Medline Convenience Kits

Medline recalls two convenience kits over sterility breach risk in included BD ChloraPrep and FREPP applicators.

What to do

Stop using the affected kits immediately. Contact Medline Industries to arrange return of the product and obtain a replacement or refund.

Recalled
Listed
Updated
Agency
FDA
Firm
Medline Industries, LP
Recall ID
99334
Status
ONGOING

Why it was recalled

Medline Industries is recalling two convenience kits because they contain BD ChloraPrep Clear 1 mL and FREPP Clear 1.5 mL applicators with a potential breach of sterility. Wrinkles in the paper lidding may extend to the seal area, compromising the sterile barrier and exposing patients to microbial contamination, which could lead to localized or serious infections.

Is mine affected?

This recall covers 25 products. Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

ProductLot codeModelUDI-DI
DRAWER 9 CRICOTHYROTOMY KIT23KDB215ACC01074110195327515515
KIT ANESTHESIA L&D A- LINE SET24LBT847, 24LBB138DYKMBNDL199A10193489848540
IVS BLOOD CULTURE KIT2023111390, 2023121890DYNDH192010653160366317
COLORECTAL ME23LBL348, 24BBA259, 24BBN513, 24BBS350, 24BBU576DYNJ906437D10195327542085
ULTRASOUND BREAST PACK23LMC035DYNJ63375C10193489851823
ARTERIAL LINE INSERTION KIT2024092790, 2025042590, 2025070290ART129510653160380733
IV START KIT LAB DRAW-SH25DBN710, 24BBH722, 24CBV460, 24EBR549, 24GBH769, 23KBN939, 23LBT913CDS860014P10888277797819
IV START KIT24AMB256, 24BMF851, 24DMC055, 24FMB552, 24IMF355, 24KMD782, 23IMI364, 23JMG372DYKM1000B10889942508143
Show all 25 products
ProductLot codeModelUDI-DI
IVS BLOOD CULTURE KIT2025022790DYNDH1920A10653160385943
KIT, I V START NSK23JBQ286DYKM218710195327232924
KIT, I V START NSK25ABI94625ABV32824LBM05824LBO55424CBB88024CBT73924CBV22624IBL53724JBL006DYKM2187A10195327628826
IV BLOOD CULTURE KIT25KME690, 25AMI449, 25BMB196, 25BMI538, 24JMG337, 24KMH747DYNDH1909A10198459146794
IV START W EXT SET KIT24DBM033DYNDV1615I10195327407100
BLOOD CULTURE TRAY PEDIATRIC24ABA808, 24BBV222, 24GBT333, 24IBU725, 23KBX578, 23LBP536DYNDH119310889942499953
BLOOD CULTURE KIT 2 W CONNECT25BMG311, 24AME318, 24BMI775, 24CMJ550, 24IMG215, 23JME381DYNDH1487A10193489484311
LABOR CDS25ABK51325DBM84125EBU47525FBQ81725HBK08623LBV28024BBN93024DBK66324DBS89024FBH87024GBR41524HBK59324JBE45624JBN93223KBQ478CDS981762B10193489306767
VAG DELIVERY ADMISSION BAG25DLA35125ELA62424BLA08624CLA27124DLA46624FLA32824GLA52623JLB27723KLB020DYKA1054F10193489312607
C-SECTION PREP25BBG443, 25EBL829, 24EBR761, 24GBC622, 24GBX458, 23LBT973DYNJ32702B10193489431070
EYE KIT24LBQ727, 24JBB775DYKM275110198459118395
EYE KIT25KMD727DYKM2751A10198459313301
CATARACT PREOP KIT24KBP388, 24JBA739DYKS1583A10198459146640
CATARACT PREOP KIT25DBM037DYKS1583B10198459292699
ORTHO ASPIRATION KIT25ABW688, 23LBT438DYKM1636A10889942925858
SHOULD BLOCK KIT24KBS611DYKM1881A10198459025174
TRIMA KIT25BBB10624KBJ75124LBO63024ABB62224CBG29024CBG29124CBT16324EBM67924FBL96324HBV58924HBV59024HBV59124HBV59224HBV59324JBV69724JBV69824JBV69923IBT69923JBS210DYNDB3077C10193489273809

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-09-01 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification