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Lower risk Medical device recall · FDA · Published December 31, 2024

Medline General Surgery Trays: Excess Material Risk in Catheter Hub

Medline recalls two surgical tray kits due to excess material on catheter hubs that could cause blockages during use. Affected items include specific model numbers and lot dates.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0992-2025Medical deviceMedline ›
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Recalling firmMEDLINE INDUSTRIES, LP - Northfield3 Lakes Dr · Northfield, IL 60093-2753
✎ GovInfoNow plain-language explainer

Medline is recalling two surgical tray kits (ART600 and ART690) because excess material on the catheter hub might cause blockages. This could lead to complications during medical procedures if the tray is used improperly. Read more at govinfonow.com/recall/53162-medline-general-surgery-trays-excess-material-risk-in-catheter-hub.

Source Summary by GovInfoNow · govinfonow.com/recall/53162-medline-general-surgery-trays-excess-material-risk-in-catheter-hub · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0992-2025

Cite this page

“Medline General Surgery Trays: Excess Material Risk in Catheter Hub.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53162-medline-general-surgery-trays-excess-material-risk-in-catheter-hub. Based on FDA recall #Z-0992-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0992-2025%22&limit=1).

The FDA announced on Dec. 31, 2024, that Medline Industries LP voluntarily recalled two General Surgery Tray kits due to manufacturing defects in the catheter subassembly. The agency issued recall number Z-0992-2025 for the affected items distributed nationwide.

How to tell if you have it

  • Brand: Medline
  • Product: ARTERIAL LINE TRAY, Item Number ART600
  • Product: A LINE TRAY, Item Number ART690
  • ART600 UDI-DI: 10653160312727 (each), 00653160312720 (case), Lot Number 2024110190
  • ART690 UDI-DI: 10653160318019 (each), 00653160318012 (case), Lot Number 2024092490
  • Quantity: 58 kits
  • Distribution: US Nationwide

The hazard

GovInfoNow's records show the catheter subassembly in the Integrated Arterial Catheter was manufactured with excess material on the catheter hub. The FDA classified this as a Class I recall.

Context

GovInfoNow's records show Medline Industries LP has 119 other recalls on record since Oct. 22, 2021. Other recent recalls of similar products include Medline medical kits recalled for light failure in intubation trays (July 25, 2025), Medline Foley Tray Kits with incorrect labeling risk (July 23, 2025), and Medline ReNewal Reprocessed St. Jude Catheters that may contain particulates (July 14, 2025). Additional recent recalls of similar products include Medline Urethral Catheter Tray Recall regarding catheter detachment risk on May 4, 2026.

How to tell if you have this one

Check for model numbers ART600 or ART690. The lot numbers 2024110190 (for ART600) and 2024092490 (for ART690) indicate affected items.

  • Brand
    Medline
  • Category
    Medical device
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class I
  • Status
    Ongoing
  • Distribution
    US Nationwide.
Recall numberProduct, codes & lotsQuantity
Z-0991-2025Medline General Surgery Tray Kits: 1) ARTERIAL LINE INSERTION KIT, Item Number ART1185B; 2) ARTERIAL LINE BUNDLE, Item Number ART255; 3) ARTERIAL LINE TRAY, Item Number ART350; 4) ARTERIAL LINE BUNDLE, Item Number ART355; 5) ARTERIAL LINE BUNDLE, Item Number ART355 ; 6) ARTERIAL LINE INSERTION TRAY, Item Number ART475; 7) ARTERIAL LINE BUNDLE - OR, Item Number ART535A; 8) ARTERIAL LINE TRAY, Item Number ART545A; 9) ARTERIAL LINE INSERTION KIT, Item Number ART775C; 10) ARTERIAL LINE TRAY, Item Number ART840; 11) ARTERIAL LINE KIT, Item Number ART890B; 1) ART1185B UDI-DI: 10653160379225(each), 00653160379228(case), Lot Number: 2024102590; 2) ART255 UDI-DI: 10653160367598(each), 00653160367591(case), Lot Number: 2024082690; 3) ART255 UDI-DI: 10653160367598(each), 00653160367591(case), Lot Number: 2024101590; 4) ART350 UDI-DI: 10653160362050(each), 00653160362053(case), Lot Number: 2024093090; 5) ART355 UDI-DI: 10653160361817(each), 00653160361810(case), Lot Number: 2024081290; 6) ART355 UDI-DI: 10653160361817(each), 00653160361810(case), Lot Number: 2024112590; 7) ART475 UDI-DI: 10653160367659(each), 00653160367652(case), Lot Number: 2024100790; 8) ART475 UDI-DI: 10653160367659(each), 00653160367652(case), Lot Number: 2024073090; 9) ART475 UDI-DI: 10653160367659(each), 00653160367652(case), Lot Number: 2024081590; 10) ART475 UDI-DI: 10653160367659(each), 00653160367652(case), Lot Number: 2024090990; 11) ART535A UDI-DI: 10653160367604(each), 00653160367607(case), Lot Number: 2024100890; 12) ART535A UDI-DI: 10653160367604(each), 00653160367607(case), Lot Number: 2024080190; 13) ART545A UDI-DI: 10653160375135(each), 00653160375138(case), Lot Number: 2024102890; 14) ART775C UDI-DI: 10653160366102(each), 00653160366105(case), Lot Number: 2024083090; 15) ART840 UDI-DI: 10653160366966(each), 00653160366969(case), Lot Number: 2024082390; 16) ART840 UDI-DI: 10653160366966(each), 00653160366969(case), Lot Number: 2024093090; 17) ART890B UDI-DI: 10653160360834(each), 00653160360837(case), Lot Number: 2024100990;942 kits
Z-0992-2025Medline General Surgery Tray kits: 1) ARTERIAL LINE TRAY, Item Number ART600; 2) A LINE TRAY, Item Number ART690; 1) ART600 UDI-DI: 10653160312727 (each), 00653160312720 (case), Lot Number 2024110190; 2) ART690 UDI-DI: 10653160318019 (each), 00653160318012 (case), Lot Number 202409249058 kits
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Verify the model number and lot date on the tray kit to confirm if it is affected.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 36 days after the firm started it.

1. Firm started the recall: Dec 31, 202412. FDA classified it Class I: Jan 29, 202523. Published in FDA’s Enforcement Report: Feb 5, 2025320242025
  1. Firm started the recall
  2. FDA classified it Class I
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Do I need to stop using these trays immediately?

The recall does not require immediate stop use; check the model and lot numbers to determine if your item is affected.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0992-2025 (December 31, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0992-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA