DuoDERM CGF Dressing 10x10CM (1x5PK) (ICC 187660) DuoDERM Extra Thin Dressing 15X15CM (1X10PK) (ICC 187957) DuoDERM Extra Thin Dressing 10X10CM (1X10PK) (ICC 187955)

Recall Insight

This FDA Devices action (record #Z-2519-2021) was formally reported on September 29, 2021, with the manufacturer initiating the action on August 9, 2021. 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 2,734,830 units 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: There is a potential for open seals which can compromise sterility. Distribution data in the federal record shows the product reached: International distribution to the countries of Argentina, Aruba, Australia, Bonaire, Brazil, Canada, Chile, , Colombia, Costa Rica, Curaco, Dominican Republic, Ecuador, Egypt, El Salvador, Guatemala, Hong Kong, Indonesi…. 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 5 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.