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ConvaTec, Inc FDA Recalls
18 recalls on file across devices, 0 of them Class I and 17 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
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| Esteem Body Soft Convex Urostomy Pouch Model/Catalog Numbers: 423703, 423704, 423705, 423707, 423708, 423709, 423710, 4Class IIJul 6, 2026Urostomy Pouches may leak from cap during use. |
| Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile RClass IIJun 8, 2026Surgical dressing manufactured out of specification (greate |
| Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mmClass IIFeb 16, 2026Drainable large pouch may leak due to manufacturing issue. |
| Convatec, EsteemBody Drainable Pouch REF:423657 10-35mmClass IIFeb 16, 2026Drainable large pouch may leak due to manufacturing issue. |
| Convatec, EsteemBody Drainable Pouch REF:423653 10-35mmClass IIFeb 16, 2026Drainable large pouch may leak due to manufacturing issue. |
| DuoDERM" Extra Thin dressings are highly flexible, control gel formula dressings designed for use on dry to lightly exudClass IIAug 29, 2025Wound dressing may have foreign matter on the product. |
| Esteem Synergy Stomahesive Skin Barrier, part of Esteem synergy, which is a two-piece ostomy system consisting of an adhClass IINov 29, 2024Ostomy skin barrier package contains a pre-cut wafer of 28mm |
| ConvaTec CarboFlex, 15cm x 20cm, 6 in. x 8 in., Order No. 403204, Odor Control Dressing, Sterile. Packaged 1 dressing/iClass IIFeb 27, 2024The product does not meet sterility assurance level. |
| Convatec EsteemBody Soft Convex, Drainable Pouch, Product codes (REF): a) 423643, b) 423658, c) 423659, d) 423664, e) 4Class IIFeb 19, 2024Convatec Inc is conducting a Voluntary Medical Device Recall |
| ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile.Class IIJan 17, 2024The kit contains a flange that has a 45mm coupling ring, how |
| ConvaTec AQUACEL Foam Ag Adhesive, wound dressing advesiveClass IINov 15, 2022ConvaTec are voluntarily recalling a batch of AQUACEL¿ Foam |
| ConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 400598. For the management of stoma output Class IIAug 16, 2022impaired functionality of the release liner |
| ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 416976. For the management of stoma outpuClass IIAug 16, 2022impaired functionality of the release liner |
| ConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 400599. For the management of stoma output Class IIAug 16, 2022impaired functionality of the release liner |
| ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/4 in., 19-64mm, REF 416975. For the management of stoma ouClass IIAug 16, 2022impaired functionality of the release liner |
| SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10 individual wafers.Class IIApr 22, 2022Firm received 10 complaints of skin barrier delamination iss |
| DuoDERM Control Gel Formula Border Dressings 15x15cm (1x5pk)Class IIAug 20, 2021Primary packaging labeling may be incorrect. |
| DuoDERM CGF Dressing 10x10CM (1x5PK) (ICC 187660) DuoDERM Extra Thin Dressing 15X15CM (1X10PK) (ICC 187957) DuoDERM ExClass IIAug 9, 2021There is a potential for open seals which can compromise ste |