Angiodynamics, Inc.: Medical Device Recall in 2024 - (Recall #: Z-1338-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

MINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 2.75" PG -Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-754

Product Classification:

Class II

Date Initiated: January 30, 2024

Date Posted: March 27, 2024

Recall Number: Z-1338-2024

Event ID: 94035

Reason for Recall:

Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case

Status: Ongoing

Product Quantity: 1676 units

Code Information:

UDI: 15051684022972 UPN: H965457541 Lot Number: Lot: 5784134 5787807 5787808 5787809 5787810 5789980 5790676 5800402 5803531

Distribution Pattern:

Worldwide distribution - US Nationwide and the countries of AT, CA, CH, CZ, ES, HK, KW, NL, NO, NZ, ZA.

Voluntary or Mandated:

Voluntary: Firm initiated