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 bal

Recall Insight

This FDA Devices action (record #Z-1037-2019) was formally reported on March 27, 2019, with the manufacturer initiating the action on January 9, 2019. It is classified under Moderate severity (Class II), with a current status of Ongoing. ConvaTec, Inc is listed as the recalling firm, operating out of Greensboro, NC. Federal records indicate 5,744,525 units total units are affected, placing this recall in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps.

The documented reason for this recall is: An internal assessment of packaging confirmed the potential for a breach in the sterile barrier. Distribution data in the federal record shows the product reached: Worldwide Distribution - US Nationwide in the states of IL, MI, PA, WI. and the countries of Algeria, Australia, Austria, Belgium, Canada, Croatia, Czechia, Czech Republic, Denmark, Egypt, Estonia, Finland, Faroe Islan…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 7 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.