Medline Industries Inc: Medical Device Recall in 2020 - (Recall #: Z-2043-2020)

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:

SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 8 Fr 3 ml - Product Usage: Medline Silicone Foley catheter is a flexible tubular device that is inserted through the urethra and used to drain urine into a collection device.

Product Classification:

Class II

Date Initiated: May 28, 2019

Date Posted: May 27, 2020

Recall Number: Z-2043-2020

Event ID: 84791

Reason for Recall:

Loose silicone particulate was found to be present on the shaft of the silicone catheters.

Status: Terminated

Product Quantity: 0

Code Information:

GTIN 40080196848837 Model DYND11553 lot 287181201.

Distribution Pattern:

US Nationwide distribution including in the states of CO, IL, KY, MO, NJ, OR, TN, TX, VA, WA.

Voluntary or Mandated:

Voluntary: Firm initiated