| 2026-06-08 |
Class II
|
Ongoing |
Z-2677-2026 |
Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R |
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Surgical dressing manufactured out of specification (greater thickness). |
| 2026-02-16 |
Class II
|
Ongoing |
Z-1584-2026 |
Convatec, EsteemBody Drainable Pouch REF:423657 10-35mm |
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Drainable large pouch may leak due to manufacturing issue. |
| 2026-02-16 |
Class II
|
Ongoing |
Z-1583-2026 |
Convatec, EsteemBody Drainable Pouch REF:423653 10-35mm |
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Drainable large pouch may leak due to manufacturing issue. |
| 2026-02-16 |
Class II
|
Ongoing |
Z-1582-2026 |
Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm |
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Drainable large pouch may leak due to manufacturing issue. |
| 2025-08-29 |
Class II
|
Ongoing |
Z-0160-2026 |
DuoDERM" Extra Thin dressings are highly flexible, control gel formula dressings designed for use on dry to lightly exud… |
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Wound dressing may have foreign matter on the product. |
| 2024-11-29 |
Class II
|
Ongoing |
Z-0903-2025 |
Esteem Synergy Stomahesive Skin Barrier, part of Esteem synergy, which is a two-piece ostomy system consisting of an adh… |
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Ostomy skin barrier package contains a pre-cut wafer of 28mm instead of 16mm and/or 35mm pre-cut wafers, as stated package labeling. If pre-cut wafers are too … |
| 2024-02-27 |
Class II
|
Ongoing |
Z-1495-2024 |
ConvaTec CarboFlex, 15cm x 20cm, 6 in. x 8 in., Order No. 403204, Odor Control Dressing, Sterile. Packaged 1 dressing/i… |
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The product does not meet sterility assurance level. |
| 2024-02-19 |
Class II
|
Ongoing |
Z-1350-2024 |
Convatec EsteemBody Soft Convex, Drainable Pouch, Product codes (REF): a) 423643, b) 423658, c) 423659, d) 423664, e) 4… |
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Convatec Inc is conducting a Voluntary Medical Device Recall (removal) for specific lots of the EsteemBody Soft Convex, Drainable Pouch due to inconsistency in … |
| 2024-01-17 |
Class II
|
Ongoing |
Z-1276-2024 |
ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile. |
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The kit contains a flange that has a 45mm coupling ring, however, the pouch within the kit is for a 57mm coupling ring. |
| 2022-11-15 |
Class II
|
Ongoing |
Z-0723-2023 |
ConvaTec AQUACEL Foam Ag Adhesive, wound dressing advesive |
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ConvaTec are voluntarily recalling a batch of AQUACEL¿ Foam Ag Adhesive 10cm x 10cm (x 10 pack) due to the identification of visual contamination in the form of… |
| 2022-08-16 |
Class II
|
Ongoing |
Z-0130-2023 |
ConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 400599. For the management of stoma output … |
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impaired functionality of the release liner |
| 2022-08-16 |
Class II
|
Ongoing |
Z-0129-2023 |
ConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 400598. For the management of stoma output … |
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impaired functionality of the release liner |
| 2022-08-16 |
Class II
|
Ongoing |
Z-0128-2023 |
ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/4 in., 19-64mm, REF 416975. For the management of stoma ou… |
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impaired functionality of the release liner |
| 2022-08-16 |
Class II
|
Ongoing |
Z-0127-2023 |
ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 416976. For the management of stoma outpu… |
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impaired functionality of the release liner |
| 2022-04-22 |
Class II
|
Terminated |
Z-1134-2022 |
SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10 individual wafers. |
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Firm received 10 complaints of skin barrier delamination issues (e.g. flange lifts from wafer, skin barrier layers separate) or tape border rips/tears. |
| 2021-08-20 |
Class II
|
Ongoing |
Z-2614-2021 |
DuoDERM Control Gel Formula Border Dressings 15x15cm (1x5pk) |
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Primary packaging labeling may be incorrect. |
| 2021-08-09 |
Class II
|
Ongoing |
Z-2519-2021 |
DuoDERM CGF Dressing 10x10CM (1x5PK) (ICC 187660) DuoDERM Extra Thin Dressing 15X15CM (1X10PK) (ICC 187957) DuoDERM Ex… |
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There is a potential for open seals which can compromise sterility. |