Teleflex Medical: Medical Device Recall in 2020 - (Recall #: Z-0797-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Teleflex MEDICAL RuSCH One piece Male External Medium Catheter W/O Tape, REF A1500M

Product Classification:

Class III

Date Initiated: February 27, 2019

Date Posted: January 22, 2020

Recall Number: Z-0797-2020

Event ID: 82307

Reason for Recall:

The device label incorrectly states that the device is sterile. This product is an externally applied male condom-type catheter designed for the management of male incontinence as an alternative to incontinence pads. In normal use, the device is neither expected nor required to be sterile.

Status: Terminated

Product Quantity: 13104 devices

Code Information:

GTIN 24026704549843 Lot Numbers: 74A1800577, 74G1802121, 74A1801939, 74H1700894, 74B1800363, 74J1700864, 74B1801604, 74J1702489, 74B1802746, 74C1801178, 74K1702257, 74L1700074, 74C1801294 , 74L1701701, 74C1802132, 74M1700121, 74G1800047, 74M1701150, 74G1800891, 74M1701769, 74G1801166

Distribution Pattern:

ME,NC, WA, MO, NJ, FL, CAL, TX, OH, IL, MA, GA, FL, GA, Canada

Voluntary or Mandated:

Voluntary: Firm initiated