CLASS II ONGOING Device recall · Reported 14 May 2025 · FDA Enforcement Report

B Braun Interventional Coaxial Dilator recalled by Galt Medical

Galt Medical is recalling B Braun Interventional Coaxial Dilator, distributed nationwide in the US. The recall was initiated on 27 Mar 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesKIT-018-47 UDI-DI code: 0404696432727 Lot Number: S25052261 KIT-019-67 UDI-DI code: 0404696432738 Lot Number: P25052052 KIT-018-41 UDI-DI code: 0404696432750 Lot Number: S25064124 KIT-019-37 UDI-DI code: 0404696432802 Lot Number: P25115062

Quantity recalled1,400 dilators

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1732-2025
FDA event ID: 96622
Recalling firm: Galt Medical, Garland, TX
Classification: Class II
Status: Ongoing
Recall initiated: 27 Mar 2025
FDA classified: 7 May 2025
Reported: 14 May 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Heart & Vascular Devices

Timeline

27 Mar 2025	Recall initiated by company
7 May 2025	Classified by FDA	+41 days
14 May 2025	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Due to a potential open seal in the sterile barrier packaging .

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

B Braun Interventional Coaxial Dilator REF: KIT-018-47, KIT-019-67, KIT-018-41, KIT-019-37 These Micro-Introducer Kits are intended to introduce up to a .038 inch guidewire or catheter into the vascular system following a small gauge needle stick.

Where it was distributed

Worldwide - U.S. Nationwide distribution in the states of AL, FL, GA, IL, MA, OH, PA, and UT. The countries of Canada, Ireland, Israel, Korea, Qatar, and United Kingdom.

Nationwide Alabama Florida Georgia Illinois Massachusetts Ohio Pennsylvania Utah

Questions about this recall

Why was it recalled?

Due to a potential open seal in the sterile barrier packaging .

Which lots are affected?

KIT-018-47 UDI-DI code: 0404696432727 Lot Number: S25052261 KIT-019-67 UDI-DI code: 0404696432738 Lot Number: P25052052 KIT-018-41 UDI-DI code: 0404696432750 Lot Number: S25064124 KIT-019-37 UDI-DI code: 0404696432802 Lot Number: P25115062

Where was it sold?

Worldwide - U.S. Nationwide distribution in the states of AL, FL, GA, IL, MA, OH, PA, and UT. The countries of Canada, Ireland, Israel, Korea, Qatar, and United Kingdom.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

6 other products · FDA event 96622

This product is part of a recall event; the main page for the event is GALT Guidewire recalled by Galt Medical.

Reported	Class	Recall	Company	Reason	Where
14 May 2025	CLASS II	GALT Guidewire recalled by Galt Medical	Galt Medical	Sterility	Nationwide
14 May 2025	CLASS II	B Braun Interventional Elite HV Hemostasis Valve Introducer System recalled	Galt Medical	Sterility	Nationwide
14 May 2025	CLASS II	Introducer Kit- Tearaway MicroSlide recalled by Galt Medical	Galt Medical	Sterility	Nationwide
14 May 2025	CLASS II	Introducer Needle recalled by Galt Medical	Galt Medical	Sterility	Nationwide
14 May 2025	CLASS II	Introducer Kit- Coaxial Dilator recalled by Galt Medical	Galt Medical	Sterility	Nationwide
14 May 2025	CLASS II	GALT Centeze Catheter recalled by Galt Medical	Galt Medical	Sterility	Nationwide

More recalls from Galt Medical

All 21

Reported	Class	Recall	Company	Reason	Where
19 Aug 2026Device	CLASS II	Boston Scientific Enhance Transcarotid/Peripheral Access Kit recalled	Galt Medical	Other	Nationwide
14 May 2025Device	CLASS II	GALT Centeze Catheter recalled by Galt Medical	Galt Medical	Sterility	Nationwide
14 May 2025Device	CLASS II	Introducer Kit- Coaxial Dilator recalled by Galt Medical	Galt Medical	Sterility	Nationwide
14 May 2025Device	CLASS II	Introducer Needle recalled by Galt Medical	Galt Medical	Sterility	Nationwide
14 May 2025Device	CLASS II	Introducer Kit- Tearaway MicroSlide recalled by Galt Medical	Galt Medical	Sterility	Nationwide

Other Heart & Vascular Devices recalls

All 6,199

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled	Atrium Medical	Potency & Assay	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes: *Bardex¿ I.C recalled	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Firm PVC Straight recalled	Atrium Medical	Potency & Assay	Nationwide