SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 10 Fr 3… recallZ-2044-2020 · Medline Industries Inc · initiated May 28, 2019
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medline Industries Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Loose silicone particulate was found to be present on the shaft of the silicone catheters.
FDA root cause category: Manufacturing material removal
What the company is doing
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.
Recall details
- Recall number
- Z-2044-2020
- Status
- Terminated
- Initiated by the company
- May 28, 2019
- Recalling firm
- Medline Industries Inc
- Quantity
- 0
- Product code
- EZL
- Distribution
- US Nationwide distribution including in the states of CO, IL, KY, MO, NJ, OR, TN, TX, VA, WA.
Product description
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.
Code information (models, lots, serial numbers)
GTIN 40884389034423 Model DYND11554 lot 287181201.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Medline DYND11554Medline Industries, Inc. · CATHETER, RETENTION TYPE, BALLOON1 recall4 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 84791).
- Z-2042-2020 · TerminatedSELECTSILICONE" 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 an…
- Z-2043-2020 · TerminatedSELECTSILICONE" 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 …
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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