Angiodynamics, Inc.: Medical Device Recall in 2024 - (Recall #: Z-1010-2024)

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:

PulseSpray Infusion System devices including: PULSE SPRAY 5F/135/20, UPN: H787125004045, REF: 12500404; Pulse Spray 3Fx135x20, UPN: H787125004155, REF: 12500415; and PULSE SPRAY 5F/45/10, UPN: H787125004235, REF: 12500423.

Product Classification:

Class II

Date Initiated: December 18, 2023

Date Posted: February 14, 2024

Recall Number: Z-1010-2024

Event ID: 93744

Reason for Recall:

Rotating adaptor O-ring manufacturing defect impacting seal integrity which may lead to a leak during infusion of medication.

Status: Ongoing

Product Quantity: 7 eaches

Code Information:

UDI-DI: 15051684013109, REF: 12500404, Lot: 5795345; UDI-DI: 15051684013215, REF: 12500415, Lot: 5793480; UDI-DI: 15051684013291, REF: 12500423, Lot: 5795344.

Distribution Pattern:

United States (MD, LA & UT), Austria, Canada and Spain.

Voluntary or Mandated:

Voluntary: Firm initiated