Angiodynamics, Inc.: Medical Device Recall in 2024 - (Recall #: Z-1768-2024)

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:

DURAMAX STACKED TIP 28CM STR. BASIC KIT, 1-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028041

Product Classification:

Class II

Date Initiated: March 18, 2024

Date Posted: May 15, 2024

Recall Number: Z-1768-2024

Event ID: 94349

Reason for Recall:

Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.

Status: Ongoing

Product Quantity: 30 units

Code Information:

UDI-DI: 15051684011846 Lot Numbers: 5805840

Distribution Pattern:

Voluntary or Mandated:

Voluntary: Firm initiated