The Recall Desk
HighFDA (Devices)·Z-1388-2024·Announced 2024-04-03

Epix Universal Clip Applier Recalled for Potential Clip Loading Failure

Applied Medical Resources is recalling the Epix Universal Clip Applier because the device may fail to load the surgical clip after the trigger is actuated. Units were distributed worldwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a risk-of-harm surgical device where the potential malfunction could affect patient care. No illnesses, injuries, or deaths have been reported in the source material. Per the rubric, risk-of-harm products where injury has not yet been reported receive a severity score of at most 3 (High).

Plain-English summary

Applied Medical Resources is recalling the Epix Universal Clip Applier (REF: CA500, STERILEEO) due to a potential malfunction where the device may fail to load the surgical clip after the trigger is actuated. This malfunction could affect the intended surgical procedure.

The affected units were distributed worldwide to healthcare facilities and providers in all regions of the United States and multiple international locations including Canada, Australia, Japan, Germany, France, and other countries.

Healthcare facilities and medical professionals should stop using affected units immediately and contact Applied Medical Resources for instructions regarding device replacement or return.

The recalled product

Product
Epix Universal Clip Applier, REF: CA500, STERILEEO
Manufacturer
Applied Medical Resources Corp
Category
Medical Device — Surgical Instruments
Hazard
  • clip-failure
  • device-malfunction

Distribution

Distributed nationwide across the United States.

Related recalls

Same category