The FDA has posted 5 enforcement recalls from ConvaTec, Inc since 2025, none of them Class I (most serious). Most recent report: Aug 26, 2026.
Urostomy Pouches may leak from cap during use.
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.
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.