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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device
Medical Devices/Surgical Equipment

Medline Integrated Arterial Catheter Kits Recalled for Catheter Hub Defect

Agency Publication Date: January 29, 2025
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Summary

Medline Industries, LP has recalled approximately 1,000 Integrated Arterial Catheter Kits used in General Surgery Trays because the catheter hub was manufactured with excess material. This defect can interfere with the device's function during arterial line insertion procedures. While no injuries or incidents have been reported, the manufacturing error could pose risks to patients during surgery.

Risk

The excess material on the catheter hub may prevent the device from connecting or functioning correctly during use. This could lead to procedure delays or complications for patients requiring arterial catheterization.

What You Should Do

  1. This recall affects Medline General Surgery Tray Kits containing Integrated Arterial Catheters, including item numbers ART1185B, ART255, ART350, ART355, ART475, ART535A, ART545A, ART775C, ART840, ART890B, ART600, and ART690.
  2. Identify affected products by checking the Item Number, Lot Number, and UDI-DI code printed on the product label. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device immediately. Contact Medline Industries, LP or your distributor to arrange for the return, replacement, or correction of the affected kits.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for additional information.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer initiated recall for clinical device.

How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Medline General Surgery Tray Kits (Integrated Arterial Catheter)
Model / REF:
ART1185B
ART255
ART350
ART355
ART475
ART535A
ART545A
ART775C
ART840
ART890B
Lot Numbers:
2024102590
2024082690
2024101590
2024093090
2024081290
2024112590
2024100790
2024073090
2024081590
2024090990
2024100890
2024080190
2024102890
2024083090
2024082390
2024100990
UDI:
10653160379225
00653160379228
10653160367598
00653160367591
10653160362050
00653160362053
10653160361817
00653160361810
10653160367659
00653160367652
10653160367604
00653160367607
10653160375135
00653160375138
10653160366102
00653160366105
10653160366966
00653160366969
10653160360834
00653160360837

Recall #: Z-0991-2025

Product: Medline General Surgery Tray Kits (Arterial Line Tray/A Line Tray)
Model / REF:
ART600
ART690
Lot Numbers:
2024110190
2024092490
UDI:
10653160312727
00653160312720
10653160318019
00653160318012

Recall #: Z-0992-2025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96093
Status: Active
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Sold By: Medline Industries, LP
Manufactured In: United States
Units Affected: 2 products (942 kits; 58 kits)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.