Medline Silicone Foley Catheter Recalled Due to Loose Silicone Particulate
Medline Industries is recalling specific lots of silicone Foley catheters because loose silicone particulate was found on the device shaft.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 is classified as FDA Class II, and the hazard 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.
Plain-English summary
Medline Industries Inc is recalling the SELECTSILICONE 100% SILICONE FOLEY CATHETER 2-WAY 8 Fr 3 ml. The recall was initiated because loose silicone particulate was found to be present on the shaft of the silicone catheters.
The affected product is identified by GTIN 40080196848837, Model DYND11553, and Lot 287181201. The FDA has classified this recall as Class II. The product was distributed nationwide in the United States, including in the states of Colorado, Illinois, Kentucky, Missouri, New Jersey, Oregon, Tennessee, Texas, Virginia, and Washington.
Consumers and healthcare facilities should check their inventory for the specific lot number and model listed above. If the product is found, it should be removed from use and returned to Medline Industries Inc or the distributor in accordance with the recall instructions.
The recalled product
- Product
- 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.
- Manufacturer
- Medline Industries Inc
- Category
- Medical Device — Catheter
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 40080196848837 Model DYND11553 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.
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