Medline Silicone Foley Catheters Recalled Due to Loose Silicone Particulate
Medline Industries is recalling 330 units of 100% Silicone Foley Catheters because loose silicone particulate was found on the device shaft.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a physical defect (loose particulate) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Medline Industries Inc is recalling 330 units of SELECTSILICONE 100% Silicone Foley Catheters, 2-Way 6 Fr 1.5 ml. The specific product is identified by GTIN 40884389034416, Model DYND11552, and Lot 287181201. These devices are flexible tubular instruments inserted through the urethra to drain urine into a collection device.
The recall was initiated because loose silicone particulate was found to be present on the shaft of the silicone catheters. The affected units were distributed nationwide in the United States, including in the states of Colorado, Illinois, Kentucky, Missouri, New Jersey, Oregon, Tennessee, Texas, Virginia, and Washington.
Healthcare facilities and consumers who have this specific lot of catheters should stop using them immediately and contact Medline Industries for instructions on return or replacement.
The recalled product
- 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.
- Manufacturer
- Medline Industries Inc
- Category
- Medical Device — Foley Catheter
- Affected units
- 330
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- GTIN 40884389034416 Model DYND11552 lot 287181201.
Distribution
Part of a larger recall action
This product is one of 3 recalled by Medline Industries Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Medline Industries Inc
See all →- HighMedline Chest Tube Kit Recalled for Non-Sterile Tape Component
FDA (Devices) · 2022-09-14
- ModerateMedline Hand Sanitizer Foam Recalled for Defective Containers
FDA (Drugs) · 2021-12-29
- ModerateBedside PICC CDS Convenience Kit Recalled for Expired Saline Component
FDA (Devices) · 2021-12-22
- HighMedline Venous Access Pack-LF Recalled for Expired Saline Component
FDA (Devices) · 2021-12-22
- HighEVLP Convenience Pack Recalled for Expired Injectable Component
FDA (Devices) · 2021-12-22
Same hazard · foreign object
See all →- SevereOutshine Strawberry Fruit Bars Recalled for Potential Glass Contamination
FDA (Food) · 2026-09-02
- SevereOutshine Black Cherry Fruit Bars Recalled for Potential Glass Contamination
FDA (Food) · 2026-09-02
- SevereOutshine Fruit Bars Recalled for Potential Glass Contamination
FDA (Food) · 2026-09-02
- SevereOutshine Fruit Bars Grape Recalled for Potential Glass Contamination
FDA (Food) · 2026-09-02
- SevereOutshine Watermelon Fruit Bars Recalled for Potential Glass Contamination
FDA (Food) · 2026-09-02