Class IIOngoingZ-1582-2026
ConvaTec, Inc recalls Convatec
Drainable large pouch may leak due to manufacturing issue.
- Ostomy With Adhesive Drainage Bag
- Process control
ConvaTec, IncNCMar 25, 2026
ConvaTec, Inc recalls
The FDA has posted 5 enforcement recalls from ConvaTec, Inc since 2025, none of them Class I (most serious). Most recent report: Mar 25, 2026.
Class II: 5
Latest recalls
View all 5 in the recall browser →Class IIOngoingZ-1583-2026
ConvaTec, Inc recalls Convatec
Drainable large pouch may leak due to manufacturing issue.
- Ostomy With Adhesive Drainage Bag
- Process control
ConvaTec, IncNCMar 25, 2026
Class IIOngoingZ-1584-2026
ConvaTec, Inc recalls Convatec
Drainable large pouch may leak due to manufacturing issue.
- Ostomy With Adhesive Drainage Bag
- Process control
ConvaTec, IncNCMar 25, 2026
Class IIOngoingZ-0160-2026
ConvaTec, Inc recalls DuoDERM" Extra Thin dressings are highly flexible
Wound dressing may have foreign matter on the product.
- Occlusive Wound Dressing
- Process control
ConvaTec, IncNCOct 22, 2025
Class IIOngoingZ-0903-2025
ConvaTec, Inc recalls Esteem Synergy Stomahesive Skin Barrier
Ostomy skin barrier package contains a pre-cut wafer of 28mm instead of 16mm and/or 35mm pre-cut wafers, as stated package labeling.…
- Ostomy Protector
- Process control
ConvaTec, IncNCJan 22, 2025
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.