Medline recalls silicone foley catheters with loose silicone particulate that could cause blockage or injury. Affected models include DYND11553 lot 287181201. Contact for return instructions.
Loose silicone particulate was found to be present on the shaft of the silicone catheters.
Medline is recalling silicone foley catheters that may have loose silicone particles on the shaft. This could lead to blockages or injury if the particles enter the urinary tract. Affected units were sold with specific model and lot numbers.
Loose silicone particles on the catheter shaft could become lodged in the urinary tract, potentially causing blockages or injury. The particles may not be visible to the user and could cause complications during catheter use.
Patients using Medline silicone foley catheters with model DYND11553 and lot 287181201 are affected. Healthcare providers and patients who use these catheters for urinary drainage are at risk.
Check for the model number DYND11553 and lot number 287181201 on the catheter packaging or label. The product was sold with the GTIN 40080196848837.
Look for the model number DYND11553 and lot number 287181201 on the catheter packaging or label.
The recall states loose silicone particulate may be present, which could cause blockages or injury. However, the hazard level is low risk as the remedy does not require immediate stop-use.
Check for the model number DYND11553 and lot number 287181201 on the catheter packaging or label. The product was sold with the GTIN 40080196848837.
The recall does not specify a remedy, so contact Medline directly for further instructions.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-2043-2020 — Medline Medline Hello, I own a Medline that is covered by recall Z-2043-2020 from Medline. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.