Angiodynamics, Inc.: Medical Device Recall in 2024 - (Recall #: Z-2454-2024)

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:

SOFT-VU KUMPE 5F X 65CM -Used for patients in need of angiographic diagnosis. Catalog Number: 10732701

Product Classification:

Class II

Date Initiated: June 18, 2024

Date Posted: August 7, 2024

Recall Number: Z-2454-2024

Event ID: 94903

Reason for Recall:

Mislabeled. The shelf-box labeling (unit of sale) is accurate for the packaged devices, however the inner pouch label may contain information for a different model (catheter length)

Status: Ongoing

Product Quantity: 595 boxes

Code Information:

UPN: H787107327015 UDI-DI: 25051684009772 (Box) 15051684009775 (Pouch) Lot Number: A0424031

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated