Medline Industries Inc SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 6 Fr 1.5 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 6 Fr 1.5 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.
Brand
Medline Industries Inc
Lot Codes / Batch Numbers
GTIN 40884389034416 Model DYND11552 lot 287181201.
Products Sold
GTIN 40884389034416 Model DYND11552 lot 287181201.
Medline Industries Inc is recalling SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 6 Fr 1.5 ml - Product Usage: Medline Silicone Fol due to Loose silicone particulate was found to be present on the shaft of the silicone catheters.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Loose silicone particulate was found to be present on the shaft of the silicone catheters.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026