Applied Medical Resources Corp: Medical Device Recall in 2019 - (Recall #: Z-0510-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.
Product Description:

GelPOINT Path Transanal Procedural Pack with Epix Electrosurgical L-Hook with Smoke Evacuation, 4x5.5cm and 5mm x 42cm REF TA211 Product Usage: The GelPOINT Path Transanal Access Platform is indicated for multiple instrument or camera access through the anus to perform various diagnostic and/or therapeutic procedures by using additional instruments.

Product Classification:

Class II

Date Initiated: December 12, 2018
Date Posted: November 27, 2019
Recall Number: Z-0510-2020
Event ID: 83909
Reason for Recall:

Unintentional shifting of the tip insulation of the firm's electrosurgical probes.

Status: Terminated
Product Quantity: 39 units Domestically and 112 units Internationally
Code Information:

Model Number: TA211 Lot Numbers: 1342169 and 1340118

Distribution Pattern:

Worldwide distribution - US Nationwide distribution and countries of Belgium; Germany; Switzerland; Spain; Finland; France; Great Britain; Israel; India; Italy; Lebanon; Netherlands; and Portugal.

Voluntary or Mandated:

Voluntary: Firm initiated