Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1732-2025 — 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.

U.S. FDA — Device Enforcement · United States · 2025-03-27 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1732-2025
Date of alert: 2025-03-27
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Galt Medical Corporation
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 0404696432727

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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-1732-2025 — 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.

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