The Recall Desk
HighFDA (Devices)·Z-2043-2025·Announced 2025-07-09

IV Catheters in Medline Kits May Fail to Retract During Insertion

Medline is recalling IV catheters in convenience kits because the needle may be slow to retract or fail to retract during insertion. 186 units were distributed nationwide in six states.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of medical devices with a mechanical failure that creates risk of needle-related injury or improper catheter placement during insertion. No illnesses or injuries have been reported, so per the rubric, this scores as High rather than Severe.

Plain-English summary

Medline Industries, LP is recalling specific Medline convenience kits that contain BD Insyte Autoguard Shielded IV Catheters (22 GA x 1.00 IN). The affected kits are labeled CC DRAWER 4 IV CIRCULATION, CC ADULT DRAWER 2, PEDI EMERGENCY TRAY-BLUE, ADULT DRAWER 4, DRAWER 4 - SUMMIT, and DRAWER 3.

The catheters have a mechanical defect: during insertion, the needle may be slow to retract or fail to retract completely. This malfunction could interfere with proper catheter placement and increase the risk of needle-related complications.

The recalled products were distributed nationwide in Indiana, Kentucky, California, Michigan, Texas, and Washington. A total of 186 units are affected. Medline has not reported any injuries related to this defect.

If you have received one of these kits, stop using it and contact Medline or your healthcare facility for replacement or instructions on safe disposal.

The recalled product

Product
Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: 1) CC DRAWER 4 IV CIRCULATION, REF ACC010254B; 2) CC ADULT DRAWER 2, REF ACC010256; 3) PEDI EMERGENCY TRAY-BLUE, REF ACC010316A; 4) ADULT DRAWER 4, REF ACC010389C;
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — IV Catheter
Hazard
  • needle-retraction-failure
  • device-malfunction

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 (18)

  • 1) REF ACC010254B: UDI/DI 10193489651683 (each)
  • 40193489651684 (case)
  • Lot Number: 24LDA269
  • 2) REF ACC010256: UDI/DI 10884389559529 (each)
  • 40884389559520 (case)
  • Lot Number: 24LDA106
  • 3) REF ACC010316A: UDI/DI 10889942831746 (each)
  • 40889942831747 (case)
  • Lot Number: 24LDA823
  • 4) REF ACC010389C: UDI/DI 10193489472493 (each)
  • 40193489472494 (case)
  • Lot Number: 24LDB092
  • 5) REF ACC010627: UDI/DI 10195327226589 (each)
  • 40195327226580 (case)
  • Lot Number: 24LDA268
  • 6) REF ACC010898: UDI/DI 10198459192074 (each)
  • 40198459192075 (case)
  • Lot Number: 24LDA260.

Distribution

Distributed nationwide across the United States.

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