Medical DeviceAug 26, 2026
ConvaTec Esteem Body Soft Convex Urostomy Pouch Model/Catalog Numbers: 423703, 423704 recall — FDA Z-2986-2026
Urostomy Pouches may leak from cap during use.
Class IIFDA: OngoingConvaTec, Inc.
Recall history in this database
Classification mix: Class II: 17.
Medical DeviceJul 15, 2026
ConvaTec Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R recall — FDA Z-2677-2026
Surgical dressing manufactured out of specification (greater thickness).
Class IIFDA: OngoingConvaTec, Inc
Medical DeviceOct 22, 2025
ConvaTec DuoDERM" Extra Thin dressings are highly flexible, control gel formula dressings recall — FDA Z-0160-2026
Wound dressing may have foreign matter on the product.
Class IIFDA: OngoingConvaTec, Inc.
Medical DeviceJan 22, 2025
ConvaTec Esteem Synergy Stomahesive Skin Barrier, part of Esteem synergy, which is a recall — FDA Z-0903-2025
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 big the device cannot be used…
Class IIFDA: OngoingConvaTec, Inc.
Medical DeviceApr 17, 2024
ConvaTec CarboFlex, 15cm x 20cm, 6 in. x 8 in., Order No. 403204, Odor Control Dressing recall — FDA Z-1495-2024
The product does not meet sterility assurance level.
Class IIFDA: OngoingConvaTec, Inc.
Medical DeviceMar 27, 2024
Convatec EsteemBody Soft Convex, Drainable Pouch, Product codes (REF): a) 423643, b) 423658 recall — FDA Z-1350-2024
Convatec Inc is conducting a Voluntary Medical Device Recall (removal) for specific lots of the EsteemBody Soft Convex, Drainable Pouch due to inconsistency in the strength of the filter…
Class IIFDA: OngoingConvaTec, Inc.
Medical DeviceMar 13, 2024
ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. recall — FDA Z-1276-2024
The kit contains a flange that has a 45mm coupling ring, however, the pouch within the kit is for a 57mm coupling ring.
Class IIFDA: OngoingConvaTec, Inc.
Medical DeviceDec 28, 2022
ConvaTec AQUACEL Foam Ag Adhesive, wound dressing advesive recall — FDA Z-0723-2023
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 brown spots present on…
Class IIFDA: OngoingConvaTec, Inc.
Medical DeviceJun 1, 2022
ConvaTec SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US recall — FDA Z-1134-2022
Firm received 10 complaints of skin barrier delamination issues (e.g. flange lifts from wafer, skin barrier layers separate) or tape border rips/tears.
Class IIFDA: TerminatedConvaTec, Inc.
Medical DeviceSep 29, 2021
ConvaTec DuoDERM CGF Dressing 10x10CM (1x5PK) (ICC 187660) DuoDERM Extra Thin Dressing recall — FDA Z-2519-2021
There is a potential for open seals which can compromise sterility.
Class IIFDA: OngoingConvaTec, Inc.
Medical DeviceNov 6, 2019
ConvaTec Convex Two-Piece Ostomy System (Skin Barrier) marketed under the following brands recall — FDA Z-0233-2020
ConvaTec has received complaints associated with use of convex two-piece skin barriers where the starter hole (stoma hole) is off-center on product manufactured from February 2017 to…
Class IIFDA: TerminatedConvaTec, Inc.
Medical DeviceMar 27, 2019
ConvaTec Nelaton Urinary Catheter, disposable, sterile, 100 eaches per sales unit recall — FDA Z-1037-2019
An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.
Class IIFDA: OngoingConvaTec, Inc.
Medical DeviceMar 27, 2019
ConvaTec Feeding Tube Metric, disposable, sterile, 100 eaches per sales unit recall — FDA Z-1036-2019
An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.
Class IIFDA: OngoingConvaTec, Inc.
Medical DeviceMar 27, 2019
ConvaTec FilterFlow Suction Handle CH24, 20 eaches per sales unit recall — FDA Z-1038-2019
An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.
Class IIFDA: OngoingConvaTec, Inc.
Medical DeviceMar 27, 2019
ConvaTec Forceps Blue, disposable, sterile, 100 eaches per sales unit recall — FDA Z-1035-2019
An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.
Class IIFDA: OngoingConvaTec, Inc.
Medical DeviceAug 22, 2018
ConvaTec AbViser AutoValve IAP recall — FDA Z-2744-2018
Bubble Leak Testing on AbViser AutoValve IAP Monitoring Devices without Transducer confirmed the potential for a pinhole breach in the sterile barrier.
Class IIFDA: TerminatedConvaTec, Inc.
Medical DeviceMay 23, 2018
Convatec Esteem(TM) Synergy Stomahesive(R), 7/8 in. / 22mm, REF 405475 Product Usage: Esteem recall — FDA Z-1890-2018
It was discovered that the stoma hole of one lots of the Esteem synergy Stomahesive Skin Barrier wafers is larger that the 7/8 inch / 22mm specified on the box label.
Class IIFDA: TerminatedConvaTec, Inc.
Understanding this recall history
This page summarizes recall records in which the official source identifies ConvaTec, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.