Z-2044-2020Class II

SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 10 Fr 3 ml -

Name: Z-2044-2020 SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 10 Fr 3 ml -
Creator: Medline Industries Inc
Published: 2019-05-28
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2019-05-28 / Terminated / root cause: manufacturing process

FDA source

Medline Industries Inc began a recall of SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 10 Fr 3 ml - Product Usage: Medline Silicone Foley catheter is a flexible tubular device that is inserted... on 2019-05-28. FDA classified it as Class II and gives the reason as "Loose silicone particulate was found to be present on the shaft of the silicone catheters". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2044-2020
Classification: Class II
Status: Terminated
Initiated: 2019-05-28
Posted: 2020-05-18
Terminated: 2023-01-30
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 10 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 code: EZL Catheter, Retention Type, Balloon
Reason for recall: Loose silicone particulate was found to be present on the shaft of the silicone catheters.
Root cause tag: manufacturing process
FDA root cause: Manufacturing material removal
Action: Medline Industries, Inc. sent formal letters with response forms to each consignee affected via 1st class mail on May 28, 2019. Each consignee was also provided with a response form to return via fax or email. The recalled product that is will be quarantined at the corporate office located at Three Lakes Drive, Northfield, IL 60093-2753 pending destruction.
Quantity in commerce: 0
Distribution: US Nationwide distribution including in the states of CO, IL, KY, MO, NJ, OR, TN, TX, VA, WA.
Product codes and lots: GTIN 40884389034423 Model DYND11554 lot 287181201.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2044-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2042-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-27	2020-05-18
Z-2043-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-27	2020-05-18
Z-2044-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-27	2020-05-18

Product code EZL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)