The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0991-2025·Announced 2025-02-05

Medline Arterial Line Insertion Kits Recalled for Catheter Hub Defect

Medline Industries is recalling 942 arterial line insertion kits due to excess material on the catheter hub of the catheter subassembly. The manufacturing defect prompted a FDA Class I recall of products distributed nationwide.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I classification combined with manufacturing defect in a medical device component used for arterial access. No deaths or serious injuries reported in the source, preventing a Critical rating.

Plain-English summary

Medline Industries is recalling 942 units of arterial line insertion and related surgical kits. The recall affects multiple product models distributed nationwide, including the Arterial Line Insertion Kit (Item ART1185B), Arterial Line Bundles (Items ART255, ART355), Arterial Line Trays (Items ART350, ART545A, ART840), and other related products.

The catheter subassembly in the Integrated Arterial Catheter component of these kits was manufactured with excess material on the catheter hub. This manufacturing defect led to a FDA Class I recall.

Affected products are identified by specific lot numbers and UDI codes detailed in the official FDA recall notice. The kits were manufactured in 2024 and distributed throughout the United States.

The recalled product

Product
Medline 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)…
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Kits / Arterial Line Insertion
Hazard
Affected units
942

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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)
  • 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)
  • Lot Number: 2024112590
  • 7) ART475 UDI-DI: 10653160367659(each)
  • 00653160367652(case)
  • Lot Number: 2024100790
  • 8) ART475 UDI-DI: 10653160367659(each)

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield

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