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

Galt Medical Introducer Kit Recall Due to Potential Packaging Seal Failure

Galt Medical Corporation is recalling 4,280 micro-introducer kits worldwide due to potential open seals in the sterile barrier packaging, which could compromise product 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 FDA Class II recall involves a potential sterile barrier compromise on a medical device intended for vascular access procedures. No illnesses or injuries have been reported, but the defect poses a theoretical contamination risk. This meets the rubric criterion for Score 3: risk-of-harm products where injury has not yet been reported.

Plain-English summary

Galt Medical Corporation is recalling 4,280 Introducer Kit - Coaxial Dilator units (multiple catalog numbers from KIT-002-28 through KIT-081-02) due to a potential open seal in the sterile barrier packaging.

The affected kits are used to introduce guidewires or catheters into the peripheral vascular system. A compromised sterile barrier could allow contamination during storage, transport, or handling.

The recall affects units distributed nationwide in Alabama, Florida, Georgia, Illinois, Massachusetts, Ohio, Pennsylvania, and Utah, as well as internationally in Canada, Ireland, Israel, Korea, Qatar, and the United Kingdom.

Healthcare facilities and clinicians using these products should discontinue use and contact Galt Medical Corporation for return instructions and replacement products.

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
  • sterile-barrier-failure
  • contamination-risk

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.

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