Galt Medical Corporation: Medical Device Recall in 2025 - (Recall #: Z-1732-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: March 27, 2025

Date Posted: May 14, 2025

Recall Number: Z-1732-2025

Event ID: 96622

Reason for Recall:

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

Status: Ongoing

Product Quantity: 1,400 dilators

Code Information:

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

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated