Angiodynamics, Inc.: Medical Device Recall in 2020 - (Recall #: Z-0418-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Angiodynamics 5F Standard Micro-Introducer Kit - indicated for percutaneous introduction of a guidewire or catheter into the vascular system, Catalog Number: 06597035 UPN: H787065970355

Product Classification:

Class II

Date Initiated: October 14, 2020

Date Posted: November 11, 2020

Recall Number: Z-0418-2021

Event ID: 86627

Reason for Recall:

5F Micro-Introducer Kits may not contain the correct device, packaged with a 4F Sheath/Dilator component

Status: Terminated

Product Quantity: 32 kits

Code Information:

Lot Number: 5626935 Expiration Date: 08/31/2023

Distribution Pattern:

US Nationwide distribution including in the states of AL, CT, GA, FL.

Voluntary or Mandated:

Voluntary: Firm initiated