The Recall Desk
HighFDA (Devices)·Z-1735-2025·Announced 2025-05-14

Galt Medical Introducer Kit Coaxial Dilator recalled for packaging seal issue

Galt Medical Corporation is recalling certain Introducer Kit–Coaxial Dilator models due to potential open seals in sterile barrier packaging, which could compromise sterility.

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 a Class II recall of a medical device (introducer kit) involving a sterile barrier packaging defect that could allow microbial contamination. Although no illnesses or injuries are reported in the source text, the hazard presents a risk of harm in invasive peripheral vascular procedures, placing it in the High category.

Plain-English summary

Galt Medical Corporation is recalling specific Introducer Kit–Coaxial Dilator models (KIT-002-28, KIT-002-34, KIT-002-35, KIT-011-40, KIT-011-62, KIT-038-04, KIT-039-03, KIT-039-13, and KIT-081-02/PS2-38) because of a potential open seal in the sterile barrier packaging. These kits are intended to introduce a .038 inch guidewire or catheter into the peripheral vascular system through a small-gauge needle stick. A total of 4,280 kits have been distributed.

The recalled kits were distributed nationwide in Alabama, Florida, Georgia, Illinois, Massachusetts, Ohio, Pennsylvania, and Utah, as well as internationally to Canada, Ireland, Israel, Korea, Qatar, and the United Kingdom. Specific lot numbers for each model are identified in the recall notice.

If you have received one of these kits, contact Galt Medical Corporation or your distributor for instructions on return or replacement. Do not use kits with potential packaging damage or seal compromise.

The recalled product

Product
Introducer Kit- Coaxial Dilator REF: KIT-002-28, 00841268104730 KIT-002-34, 00841268104792 KIT-002-35, 00841268104808 KIT-011-40, 00841268105553 KIT-011-62, 00841268105614 KIT-038-04, 00841268104556 KIT-039-03, 00841268104587 KIT-039-13, 00841268106055 KIT-081-02 / PS2-
Manufacturer
Galt Medical Corporation
Category
Medical Device — Vascular Access / Introducer Kit
Hazard
Affected units
4,280

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 (8)

  • UDI-DI code: 00841268104792 Lot Number: G25064259 KIT-002-35
  • UDI-DI code: 00841268104808 Lot Number: G25029077 KIT-011-40
  • UDI-DI code: 00841268105553 Lot Number: S25031227 KIT-011-62
  • UDI-DI code: 00841268105614 Lot Numbers: G25052163 G25080165 KIT-038-04
  • UDI-DI code: 00841268104556 Lot Number: G25092186 KIT-039-03
  • UDI-DI code: 00841268104587 Lot Numbers: G25050190 G25078192 KIT-039-13
  • UDI-DI code: 00841268106055 Lot Number: G25050202 KIT-081-02 / PS2-38
  • UDI-DI code: 00841268108394 Lot Number: G25056231

Distribution

Distributed nationwide across the United States.

The notice also names 8 states specifically:

Part of a larger recall action

This product is one of 7 recalled by Galt Medical Corporation 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 7 products in this recall →

Related recalls

Same manufacturer · Galt Medical Corporation

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Same hazard · sterile barrier compromise

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