Teleflex Medical: Medical Device Recall in 2020 - (Recall #: Z-0796-2020)

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 Regular Catheter W/O Tape, REF A1500

Product Classification:

Class III

Date Initiated: February 27, 2019

Date Posted: January 22, 2020

Recall Number: Z-0796-2020

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: 39456 devices

Code Information:

GTIN 24026704549836 Lot Numbers: 74A1800914, 74A1801938, 74A1802088, 74B1800292, 74B1800362, 74B1801603, 74C1800428, 74C1801090, 74C1801172, 74C1802127, 74E1800684, 74E1802780, 74F1800358, 74F1801409, 74F1801915, 74G1800046, 74G1800893, 74G1801165, 74H1700889, 74H1701630, 74H1702627, 74J1701765, 74J1702485, 74K1700319, 74L1700073, 74L1700304

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated