--- title: "MEDLINE Medical Procedure Kits labeled as BIOBURDEN TEST KIT, Kit Uro Robot C... — FDA record Z-2497-2026 | Is It on Recall" description: "During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularitie" url: https://isitonrecall.com/recall/fda-device-z-2497-2026-medline-medical-procedure-kits-labeled-as-bioburden-test-kit-kit-uro-robot-cystectomy-etc-see-the-re/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # MEDLINE Medical Procedure Kits labeled as BIOBURDEN TEST KIT, Kit Uro Robot Cystectomy, etc. (see the recall document... — FDA record Z-2497-2026 Reported ongoing Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice. Source date May 4, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **Product**: MEDLINE Medical Procedure Kits labeled as BIOBURDEN TEST KIT, Kit Uro Robot Cystectomy, etc. (see the recall documents for a full list of products) - **Reason**: During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification. - **Classification**: Class II - **Recalling firm**: Medline Industries, LP - **Quantity**: 123030 units - **Agency-reported status**: Ongoing - **Source record identifier**: Z-2497-2026 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2497-2026%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice. ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | Medline Kit Number/SKU BIOB686: UDI/DI 10193489684025 (each), 40193489684026 (case), Lot Number 22CMD618; Medline Kit Number/SKU DYNJ83242: UDI/DI 10195327242398 (each), 40195327242399 (case), Lot Number 23BBK690; Medline Kit Number/SKU DYNJ83242: UDI/DI 10195327242398 (each), 40195327242399 (case), Lot Number 23ABK356; Medline Kit Number/SKU DYNJ83242: UDI/DI 10195327242398 (each), 40195327242399 (case), Lot Number 23ABG037; Medline Kit Number/SKU DYNJ83242: UDI/DI 10195327242398 (each), 40195327242399 (case), Lot Number 22IBL708; Medline Kit Number/SKU DYNJ83242A: UDI/DI 10195327350727 (each), 40195327350728 (case), Lot Number 24GBK706; Medline Kit Number/SKU DYNJ83242A: UDI/DI 10195327350727 (each), 40195327350728 (case), Lot Number 24GBH415; Medline Kit Number/SKU DYNJ83242A: UDI/DI 10195327350727 (each), 40195327350728 (case), Lot Number 24FBQ282; Medline Kit Number/SKU DYNJ83242A: UDI/DI 10195327350727 (each), 40195327350728 (case), Lot Number 24FBC513; Medline Kit Number/SKU DYNJ83242A: UDI/DI 10195327350727 (each), 40195327350728 (case), Lot Number 23KBK097; Medline Kit Number/SKU DYNJ83242A: UDI/DI 10195327350727 (each), 40195327350728 (case), Lot Number 23DBF286; Medline Kit Number/SKU DYNJ83242A: UDI/DI 10195327350727 (each), 40195327350728 (case), Lot Number 23CBI425; Medline Kit Number/SKU DYNJ83242C: UDI/DI 10198459575655 (each), 40198459575656 (case), Lot Number 26DBE336; Medline Kit Number/SKU DYNJ67486A: UDI/DI 10193489888768 (each), 40193489888769 (case), Lot Number 22ABR834; Medline Kit Number/SKU DYNJ67486A: UDI/DI 10193489888768 (each), 40193489888769 (case), Lot Number 21HBL801; Medline Kit Number/SKU DYNJ67486A: UDI/DI 10193489888768 (each), 40193489888769 (case), Lot Number 21FBK710; Medline Kit Number/SKU DYNJ14052D: UDI/DI 10888277538689 (each), 40888277538680 (case), Lot Number 24ABS522; Medline Kit Number/SKU DYNJ14052D: UDI/DI 10888277538689 (each), 40888277538680 (case), Lot Number 23HBB533; Medline Kit Number/SKU DYNJ14052D: UDI/DI 10888277538689 (each), 40888277538680 (case), Lot Number 23BBD374; Medline Kit Number/SKU DYNJ14052D: UDI/DI 10888277538689 (each), 40888277538680 (case), Lot Number 22HBN112; Medline Kit Number/SKU DYNJ14052D: UDI/DI 10888277538689 (each), 40888277538680 (case), Lot Number 22OBA524; Medline Kit Number/SKU DYNJ14052D: UDI/DI 10888277538689 (each), 40888277538680 (case), Lot Number 21JBN396; Medline Kit Number/SKU DYNJ14052D: UDI/DI 10888277538689 (each), 40888277538680 (case), Lot Number 21ABG632; Medline Kit Number/SKU DYNJ14052F: UDI/DI 10195327659646 (each), 40195327659647 (case), Lot Number 25CBE701; Medline Kit Number/SKU DYNJ14052F: UDI/DI 10195327659646 (each), 40195327659647 (case), Lot Number 24HBD087; Medline Kit Number/SKU DYNJ14052F: UDI/DI 10195327659646 (each), 40195327659647 (case), Lot Number 24GBW446; Medline Kit Number/SKU DYNJ14053D: UDI/DI 10884389650059 (each), 40884389650050 (case), Lot Number 23JBH039; Medline Kit Number/SKU DYNJ14053D: UDI/DI 10884389650059 (each), 40884389650050 (case), Lot Number 23GBK315; Medline Kit Number/SKU DYNJ14053D: UDI/DI 10884389650059 (each), 40884389650050 (case), Lot Number 23FBF483; Medline Kit Number/SKU DYNJ14053D: UDI/DI 10884389650059 (each), 40884389650050 (case), Lot Number 23EBC641; Medline Kit Number/SKU DYNJ14053D: UDI/DI 10884389650059 (each), 40884389650050 (case), Lot Number 23CBF936; Medline Kit Number/SKU DYNJ14053D: UDI/DI 10884389650059 (each), 40884389650050 (case), Lot Number 23ABJ282; Medline Kit Number/SKU DYNJ14053D: UDI/DI 10884389650059 (each), 40884389650050 (case), Lot Number 22HBL398; Medline Kit Number/SKU DYNJ14053D: UDI/DI 10884389650059 (each), 40884389650050 (case), Lot Number 22GBI901; Medline Kit Number/SKU DYNJ14053D: UDI/DI 10884389650059 (each), 40884389650050 (case), Lot Number 22FBB507; Medline Kit Number/SKU DYNJ14053D: UDI/DI 10884389650059 (each), 40884389650050 (case), Lot Number 21LBT981; Medline Kit Number/SKU DYNJ14053D: UDI/DI 10884389650059 (each), 40884389650050 (case), Lot Number 21KBR323; Medline Kit Number/SKU DYNJ14053D: UDI/DI 10884389650059 (each), 40884389650050 (case), Lot Number 21JBB953; Medline Kit Number/SKU DYNJ14053F: UDI/DI 10195327557324 (each), 40195327557325 (case), Lot Number 24BBF579; Medline Kit Number/SKU DYNJ14053F: UDI/DI 10195327557324 (each), 40195327557325 (case), Lot Number 24ABF455; Medline Kit Number/SKU DYNJ14053F: UDI/DI 10195327557324 (each), 40195327557325 (case), Lot Number 23KBJ248; Medline Kit Number/SKU DYNJ14053G: UDI/DI 10195327659691 (each), 40195327659692 (case), Lot Number 25HBQ577; Medline Kit Number/SKU DYNJ14053G: UDI/DI 10195327659691 (each), 40195327659692 (case), Lot Number 25FBR065; Medline Kit Number/SKU DYNJ14053G: UDI/DI 10195327659691 (each), 40195327659692 (case), Lot Number 25BBO494; Medline Kit Number/SKU DYNJ14053G: UDI/DI 10195327659691 (each), 40195327659692 (case), Lot Number 25ABT696; Medline Kit Number/SKU DYNJ14053G: UDI/DI 10195327659691 (each), 40195327659692 (case), Lot Number 24LBO115; Medline Kit Number/SKU DYNJ14053G: UDI/DI 10195327659691 (each), 40195327659692 (case), Lot Number 24IBQ383; Medline Kit Number/SKU DYNJ14053G: UDI/DI 10195327659691 (each), 40195327659692 (case), Lot Number 24FBQ534; Medline Kit Number/SKU DYNJ14053G: UDI/DI 10195327659691 (each), 40195327659692 (case), Lot Number 24DBW093; Medline Kit Number/SKU DYNJ22034L: UDI/DI 10889942029075 (each), 40889942029076 (case), Lot Number 25FBT434; Medline Kit Number/SKU DYNJ22034L: UDI/DI 10889942029075 (each), 40889942029076 (case), Lot Number 25EBA275; Medline Kit Number/SKU DYNJ22034L: UDI/DI 10889942029075 (each), 40889942029076 (case), Lot Number 25CBC307; Medline Kit Number/SKU DYNJ22034L: UDI/DI 10889942029075 (each), 40889942029076 (case), Lot Number 24LBN987; Medline Kit Number/SKU DYNJ22034L: UDI/DI 10889942029075 (each), 40889942029076 (case), Lot Number 24JBV674; Medline Kit Number/SKU DYNJ22034L: UDI/DI 10889942029075 (each), 40889942029076 (case), Lot Number 24JBH121; Medline Kit Number/SKU DYNJ22034L: UDI/DI 10889942029075 (each), 40889942029076 (case), Lot Number 24FBT743; Medline Kit Number/SKU DYNJ22034L: UDI/DI 10889942029075 (each), 40889942029076 (case), Lot Number 24ABT450; Medline Kit Number/SKU DYNJ22034L: UDI/DI 10889942029075 (each), 40889942029076 (case), Lot Number 23LBQ074; Medline Kit Number/SKU DYNJ22034L: UDI/DI 10889942029075 (each), 40889942029076 (case), Lot Number 23KBO483; Medline Kit Number/SKU DYNJ22034L: UDI/DI 10889942029075 (each), 40889942029076 (case), Lot Number 23JBM626; Medline Kit Number/SKU DYNJ22034L: UDI/DI 10889942029075 (each), 40889942029076 (case), Lot Number 23HBE700; Medline Kit Number/SKU DYNJ22034L: UDI/DI 10889942029075 (each), 40889942029076 (case), Lot Number 23FBR569; Medline Kit Number/SKU DYNJ22034L: UDI/DI 10889942029075 (each), 40889942029076 (case), Lot Number 23EBK172; Medline Kit Number/SKU DYNJ22034L: UDI/DI 10889942029075 (each), 40889942029076 (case), Lot Number 23BBP127; Medline Kit Number/SKU DYNJ22034L: UDI/DI 10889942029075 (each), 40889942029076 (case), Lot Number 22JBP763; Medline Kit Number/SKU DYNJ22034L: UDI/DI 10889942029075 (each), 40889942029076 (case), Lot Number 22HBT812; Medline Kit Number/SKU DYNJ22034L: UDI/DI 10889942029075 (each), 40889942029076 (case), Lot Number 22EBA856; Medline Kit Number/SKU DYNJ22034L: UDI/DI 10889942029075 (each), 40889942029076 (case), Lot Number 21IBD788; Medline Kit Number/SKU DYNJ22034L: UDI/DI 10889942029075 (each), 40889942029076 (case), Lot Number 21GBW500; Medline Kit Number/SKU DYNJ22034L: UDI/DI 10889942029075 (each), 40889942029076 (case), Lot Number 21GBW511; Medline Kit Number/SKU DYNJ22034L: UDI/DI 10889942029075 (each), 40889942029076 (case), Lot Number 21GBC067; Medline Kit Number/SKU DYNJ22034L: UDI/DI 10889942029075 (each), 40889942029076 (case), Lot Number 21EBD882; Medline Kit Number/SKU DYNJ22034L: UDI/DI 10889942029075 (each), 40889942029076 (case), Lot Number 20XBG601; Medline Kit Number/SKU DYNJ22034M: UDI/DI 10198459438240 (each), 40198459438241 (case), Lot Number 26DBA262; Medline Kit Number/SKU DYNJ22034M: UDI/DI 10198459438240 (each), 40198459438241 (case), Lot Number 25KBQ726; Medline Kit Number/SKU DYNJ22034M: UDI/DI 10198459438240 (each), 40198459438241 (case), Lot Number 25JBD475; Medline Kit Number/SKU DYNJ22034M: UDI/DI 10198459438240 (each), 40198459438241 (case), Lot Number 25HBE134; Medline Kit Number/SKU DYNJ89738: UDI/DI 10198459289392 (each), 40198459289393 (case), Lot Number 26DBE946; Medline Kit Number/SKU DYNJ89738: UDI/DI 10198459289392 (each), 40198459289393 (case), Lot Number 26BBC953; Medline Kit Number/SKU DYNJ89738: UDI/DI 10198459289392 (each), 40198459289393 (case), Lot Number 25LBF474; Medline Kit Number/SKU DYNJ89738: UDI/DI 10198459289392 (each), 40198459289393 (case), Lot Number 25DBF635; Medline Kit Number/SKU DYNJ89780: UDI/DI 10198459289439 (each), 40198459289430 (case), Lot Number 26DBN360; Medline Kit Number/SKU DYNJ89780: UDI/DI 10198459289439 (each), 40198459289430 (case), Lot Number 26CBS912; Medline Kit Number/SKU DYNJ89780: UDI/DI 10198459289439 (each), 40198459289430 (case), Lot Number 25LBP227; Medline Kit Number/SKU DYNJ89780: UDI/DI 10198459289439 (each), 40198459289430 (case), Lot Number 25JBM030; Medline Kit Number/SKU DYNJ89780: UDI/DI 10198459289439 (each), 40198459289430 (case), Lot Number 25IBS945; Medline Kit Number/SKU DYNJ89780: UDI/DI 10198459289439 (each), 40198459289430 (case), Lot Number 25IBK162; Medline Kit Number/SKU DYNJ89780: UDI/DI 10198459289439 (each), 40198459289430 (case), Lot Number 25DBB675; Medline Kit Number/SKU CDS982277M: UDI/DI 10193489206067 (each), 40193489206068 (case), Lot Number 23FME428; Medline Kit Number/SKU CDS982277M: UDI/DI 10193489206067 (each), 40193489206068 (case), Lot Number 23DMI542; Medline Kit Number/SKU CDS982277M: UDI/DI 10193489206067 (each), 40193489206068 (case), Lot Number 23DMA290; Medline Kit Number/SKU CDS982277M: UDI/DI 10193489206067 (each), 40193489206068 (case), Lot Number 23CMB751; Medline Kit Number/SKU CDS982277M: UDI/DI 10193489206067 (each), 40193489206068 (case), Lot Number 23AMH953; Medline Kit Number/SKU CDS982277M: UDI/DI 10193489206067 (each), 40193489206068 (case), Lot Number 22LME866; Medline Kit Number/SKU CDS982277M: UDI/DI 10193489206067 (each), 40193489206068 (case), Lot Number 22KMH068; Medline Kit Number/SKU CDS982277M: UDI/DI 10193489206067 (each), 40193489206068 (case), Lot Number 22LMC181; Medline Kit Number/SKU CDS982277M: UDI/DI 10193489206067 (each), 40193489206068 (case), Lot Number 22JME158; Medline Kit Number/SKU CDS982277M: UDI/DI 10193489206067 (each), 40193489206068 (case), Lot Number 22IMH577; Medline Kit Number/SKU CDS982277M: UDI/DI 10193489206067 (each), 40193489206068 (case), Lot Number 22HMF488; Medline Kit Number/SKU CDS982277M: UDI/DI 10193489206067 (each), 40193489206068 (case), Lot Number 22GMD546; Medline Kit Number/SKU CDS982277M: UDI/DI 10193489206067 (each), 40193489206068 (case), Lot Number 22FMC984; Medline Kit Number/SKU CDS982277M: UDI/DI 10193489206067 (each), 40193489206068 (case), Lot Number 22CMF179; Medline Kit Number/SKU CDS982277M: UDI/DI 10193489206067 (each), 40193489206068 (case), Lot Number 22CMB409; Medline Kit Number/SKU CDS982277M: UDI/DI 10193489206067 (each), 40193489206068 (case), Lot Number 22BMH204; Medline Kit Number/SKU CDS982277M: UDI/DI 10193489206067 (each), 40193489206068 (case), Lot Number 21LMA653; Medline Kit Number/SKU CDS982277M: UDI/DI 10193489206067 (each), 40193489206068 (case), Lot Number 21KMD039; Medline Kit Number/SKU CDS982277M: UDI/DI 10193489206067 (each), 40193489206068 (case), Lot Number 21IMG685; Medline Kit Number/SKU CDS982277M: UDI/DI 10193489206067 (each), 40193489206068 (case), Lot Number 21HMF649; Medline Kit Number/SKU CDS982277M: UDI/DI 10193489206067 (each), 40193489206068 (case), Lot Number 21GMC529; Medline Kit Number/SKU CDS982277M: UDI/DI 10193489206067 (each), 40193489206068 (case), Lot Number 21FMC385; Medline Kit Number/SKU CD... | The agency lot list is longer than this excerpt. [Read the complete list at the official source](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2497-2026%22). Match all identifying details in the current notice. A brand name alone is not enough. ## Distribution Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI. States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address. - [Alaska](https://isitonrecall.com/state/alaska/) - [Alabama](https://isitonrecall.com/state/alabama/) - [Arkansas](https://isitonrecall.com/state/arkansas/) - [Arizona](https://isitonrecall.com/state/arizona/) - [California](https://isitonrecall.com/state/california/) - [Colorado](https://isitonrecall.com/state/colorado/) - [Connecticut](https://isitonrecall.com/state/connecticut/) - [Delaware](https://isitonrecall.com/state/delaware/) - [Florida](https://isitonrecall.com/state/florida/) - [Georgia](https://isitonrecall.com/state/georgia/) - [Hawaii](https://isitonrecall.com/state/hawaii/) - [Iowa](https://isitonrecall.com/state/iowa/) - [Idaho](https://isitonrecall.com/state/idaho/) - [Illinois](https://isitonrecall.com/state/illinois/) - [Indiana](https://isitonrecall.com/state/indiana/) - [Kansas](https://isitonrecall.com/state/kansas/) - [Kentucky](https://isitonrecall.com/state/kentucky/) - [Louisiana](https://isitonrecall.com/state/louisiana/) - [Massachusetts](https://isitonrecall.com/state/massachusetts/) - [Maryland](https://isitonrecall.com/state/maryland/) - [Maine](https://isitonrecall.com/state/maine/) - [Michigan](https://isitonrecall.com/state/michigan/) - [Minnesota](https://isitonrecall.com/state/minnesota/) - [Missouri](https://isitonrecall.com/state/missouri/) - [Mississippi](https://isitonrecall.com/state/mississippi/) - [Montana](https://isitonrecall.com/state/montana/) - [North Carolina](https://isitonrecall.com/state/north-carolina/) - [North Dakota](https://isitonrecall.com/state/north-dakota/) - [Nebraska](https://isitonrecall.com/state/nebraska/) - [New Hampshire](https://isitonrecall.com/state/new-hampshire/) - [New Jersey](https://isitonrecall.com/state/new-jersey/) - [New Mexico](https://isitonrecall.com/state/new-mexico/) - [Nevada](https://isitonrecall.com/state/nevada/) - [New York](https://isitonrecall.com/state/new-york/) - [Ohio](https://isitonrecall.com/state/ohio/) - [Oklahoma](https://isitonrecall.com/state/oklahoma/) - [Oregon](https://isitonrecall.com/state/oregon/) - [Pennsylvania](https://isitonrecall.com/state/pennsylvania/) - [Rhode Island](https://isitonrecall.com/state/rhode-island/) - [South Carolina](https://isitonrecall.com/state/south-carolina/) - [South Dakota](https://isitonrecall.com/state/south-dakota/) - [Tennessee](https://isitonrecall.com/state/tennessee/) - [Texas](https://isitonrecall.com/state/texas/) - [Utah](https://isitonrecall.com/state/utah/) - [Virginia](https://isitonrecall.com/state/virginia/) - [Vermont](https://isitonrecall.com/state/vermont/) - [Washington](https://isitonrecall.com/state/washington/) - [Wisconsin](https://isitonrecall.com/state/wisconsin/) - [West Virginia](https://isitonrecall.com/state/west-virginia/) - [Wyoming](https://isitonrecall.com/state/wyoming/) ## Dates in the source - **Report date**: Jun 24, 2026 - **Recall initiation date**: May 4, 2026 - **Center classification date**: Jun 17, 2026 FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2497-2026%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [Medline Industries, LP records](https://isitonrecall.com/brand/medline-industries-lp/)