Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Nelaton Urinary Catheter Recalled by ConvaTec, Inc Due to An internal assessment of packaging confirmed the potential...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact ConvaTec, Inc directly.
Affected Products
Nelaton Urinary Catheter, disposable, sterile, 100 eaches per sales unit. Labeled as: CH16/40CM and CH14/40CM Product Usage: Urinary Catheters are sterile disposable devices intended to provide an intermittent pathway for drainage of fluids from the bladder. They are intended to be inserted intermittently through the urethra and up to the bladder enabling urine to drain. They are designed for short-term, intermittent transient use only and are not intended to be left in situ (there is no balloon on the tip to allow the catheter to be retained within the bladder). They are intended for single use only. They are intended to be removed once the bladder is fully drained. The goal of intermittent catheterization using Urology Catheters is to completely empty the bladder and prevent Urinary Tract Infections (UTIs).
Quantity: 5,744,525 units total
Why Was This Recalled?
An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About ConvaTec, Inc
ConvaTec, Inc has 40 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report