The FDA has posted 6 enforcement recalls from ConvaTec, Inc since 2025, none of them Class I (most serious). Most recent report: Jul 15, 2026.
Surgical dressing manufactured out of specification (greater thickness).
Drainable large pouch may leak due to manufacturing issue.
Drainable large pouch may leak due to manufacturing issue.
Drainable large pouch may leak due to manufacturing issue.
Wound dressing may have foreign matter on the product.
Ostomy skin barrier package contains a pre-cut wafer of 28mm instead of 16mm and/or 35mm pre-cut wafers, as stated package labeling.…
Firm name as filed with the FDA: “ConvaTec, Inc”. Related firm entities may file under separate names. Source: U.S. FDA openFDA device enforcement reports. Informational only — verify with the FDA before acting.