Greensboro, NC, United States
ConvaTec, Inc recalls
18 recalls recorded since 2018, most recently on 6 July 2026. 13 are listed as ongoing. Status and classification are as published by the FDA.
Recalls18
Ongoing (FDA)13
Terminated or completed5
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 6 July 2026
- Reason
- Urostomy Pouches may leak from cap during use.
- Distribution
- US Nationwide distribution including in the states of AR, AZ, CA, CO, DC, DE, FL, GA, IA, IL, IN, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, OR, PA, RI, SC, TN, TX, UT, VA, WA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2986-2026
- Esteem Body Soft Convex Urostomy Pouch Model/Catalog Numbers: 423703, 423704, 423705, 423707, 423708, 423709, 423710, 423712, 423713, 423714, 423715, 423716, 423717, 423718, 423721, 423722, 423723, 423725, 423726, 42372
Ongoing Class II Medical devices
- Recall started
- 8 June 2026
- Reason
- Surgical dressing manufactured out of specification (greater thickness).
- Distribution
- US Nationwide distribution in the states of MD, OH, IL, NC, AZ, NY, MN, TX, KS, TN, IN, DE, MI, FL, PA, CA, VA, MS, NM, GA, CO.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2677-2026
- Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R
Ongoing Class II Medical devices
- Recall started
- 16 February 2026
- Reason
- Drainable large pouch may leak due to manufacturing issue.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Canada, China, Czech Republic, Denmark, Finland, Germany, Ireland, Italy, Japan, Netherlands, Norway, Poland, Slovakia, Sweden, Switzerland, UK.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1582-2026, Z-1583-2026, Z-1584-2026
- Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm
- Convatec, EsteemBody Drainable Pouch REF:423653 10-35mm
- Convatec, EsteemBody Drainable Pouch REF:423657 10-35mm
Ongoing Class II Medical devices
- Recall started
- 29 August 2025
- Reason
- Wound dressing may have foreign matter on the product.
- Distribution
- US Nationwide distribution including in the states of OH, AL, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NY, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0160-2026
- DuoDERM" Extra Thin dressings are highly flexible, control gel formula dressings designed for use on dry to lightly exudating wounds. DuoDERM" Extra Thin dressings are particularly suitable in areas subject to friction a
Ongoing Class II Medical devices
- Recall started
- 29 November 2024
- Reason
- 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 and if the pre-cut wafer is too small and the device user tries to apply, this could cause abrasion, stomal cut, and bleeding
- Distribution
- US distribution to states of: OH, NY, IL
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0903-2025
- Esteem Synergy Stomahesive Skin Barrier, part of Esteem synergy, which is a two-piece ostomy system consisting of an adhesive skin barrier and an adhesive pouch: ESTEEM SYN FLX WHT16/35MM PRECUT(1X10), REF: 405473; ESTE
Ongoing Class II Medical devices
- Recall started
- 27 February 2024
- Reason
- The product does not meet sterility assurance level.
- Distribution
- US Nationwide distribution in the states of CA, MO, NM, PA, TX, and WA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1495-2024
- ConvaTec CarboFlex, 15cm x 20cm, 6 in. x 8 in., Order No. 403204, Odor Control Dressing, Sterile. Packaged 1 dressing/immediate package, 5 packages/market unit.
Ongoing Class II Medical devices
- Recall started
- 19 February 2024
- Reason
- 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 weld.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Italy, UK.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1350-2024
- Convatec EsteemBody Soft Convex, Drainable Pouch, Product codes (REF): a) 423643, b) 423658, c) 423659, d) 423664, e) 423666, f) 423645, g) 423667, h) 423657, i) 423652, j) 423646, k) 423654, l) 423653, m) 423647, n) 42
Ongoing Class II Medical devices
- Recall started
- 17 January 2024
- Reason
- The kit contains a flange that has a 45mm coupling ring, however, the pouch within the kit is for a 57mm coupling ring.
- Distribution
- Distribution was made to AK, CA, FL, IL, IN, MI, NE, NJ, NY, OH, PA, and TX. There was government distribution but no military distribution. Foreign distribution was made to Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1276-2024
- ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile.
Ongoing Class II Medical devices
- Recall started
- 15 November 2022
- Reason
- 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 several dressings.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0723-2023
- ConvaTec AQUACEL Foam Ag Adhesive, wound dressing advesive
Ongoing Class II Medical devices
- Recall started
- 16 August 2022
- Reason
- impaired functionality of the release liner
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0129-2023, Z-0128-2023, Z-0127-2023, Z-0130-2023
- ConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 400598. For the management of stoma output following a colostomy or ileostomy procedure.
- ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/4 in., 19-64mm, REF 416975. For the management of stoma output following a colostomy or ileostomy procedure.
- ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 416976. For the management of stoma output following a colostomy or ileostomy procedure.
- ConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 400599. For the management of stoma output following a colostomy or ileostomy procedure.
Terminated Class II Medical devices
- Recall started
- 22 April 2022
- Terminated
- 4 March 2026
- Reason
- Firm received 10 complaints of skin barrier delamination issues (e.g. flange lifts from wafer, skin barrier layers separate) or tape border rips/tears.
- Distribution
- Distributed nationwide to NJ, PA, OH, CA, AL, MI, NY, TX, FL, NC, VA, LA, IL, DE, KY, WA, KS, MN, MS and internationally to India.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1134-2022
- SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10 individual wafers.
Ongoing Class II Medical devices
- Recall started
- 20 August 2021
- Reason
- Primary packaging labeling may be incorrect.
- Distribution
- Distribution in US and Canada US distribution in CA, FL, GA, IL, MD, MN, NC. NM, NJ, OH, PA, TX, VA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2614-2021
- DuoDERM Control Gel Formula Border Dressings 15x15cm (1x5pk)
Ongoing Class II Medical devices
- Recall started
- 9 August 2021
- Reason
- There is a potential for open seals which can compromise sterility.
- Distribution
- International distribution to the countries of Argentina, Aruba, Australia, Bonaire, Brazil, Canada, Chile, , Colombia, Costa Rica, Curaco, Dominican Republic, Ecuador, Egypt, El Salvador, Guatemala, Hong Kong, Indonesia, Iran, Malaysia, Mexico, Myanmar, Nicaragua, New Zealand, Panama, Peru, , Pakis
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2519-2021
- DuoDERM CGF Dressing 10x10CM (1x5PK) (ICC 187660) DuoDERM Extra Thin Dressing 15X15CM (1X10PK) (ICC 187957) DuoDERM Extra Thin Dressing 10X10CM (1X10PK) (ICC 187955)
Terminated Class II Medical devices
- Recall started
- 6 September 2019
- Terminated
- 30 November 2022
- Reason
- 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 September 2018. FDA became aware of this problem via routine MDR monitoring.
- Distribution
- Worldwide distributions.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0233-2020
- Convex Two-Piece Ostomy System (Skin Barrier) marketed under the following brands: 1) Combihesive Natura Durahesive 2) SurFit Natura Durahesive 3) Natura 4) Varicare Product Usage: stoma management
Ongoing Class II Medical devices
- Recall started
- 9 January 2019
- Reason
- An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.
- Distribution
- Worldwide Distribution - US Nationwide in the states of IL, MI, PA, WI. and the countries of Algeria, Australia, Austria, Belgium, Canada, Croatia, Czechia, Czech Republic, Denmark, Egypt, Estonia, Finland, Faroe Islands, France, Germany, Greece, Hong Kong, Hungary, Iceland, Israel, Italy, Kenya, K
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1037-2019, Z-1036-2019, Z-1038-2019, Z-1035-2019
- Nelaton Urinary Catheter, disposable, sterile, 100 eaches per sales unit. Labeled as: CH16/40CM and CH14/40CM Product Usage: Urinary Catheters are sterile disposable devices intended to provide an intermittent pathwa
- Feeding Tube Metric, disposable, sterile, 100 eaches per sales unit. Labeled as: xray CH05/40CM and xray CH08/40CM Product Usage: Duodenal and Stomach Gastroenterology Tubes are sterile disposable devices which may b
- FilterFlow Suction Handle CH24, 20 eaches per sales unit. Product Usage: Filter Flow is designed for orthopedic surgery and combines suctioning function with filtering. The device is intended for orthopedic surgical
- Forceps Blue, disposable, sterile, 100 eaches per sales unit. Product Usage: Forceps are sterile disposable devices intended for use during clinical procedures to grasp, manipulate, maneuver or assist with the remova
Terminated Class II Medical devices
- Recall started
- 3 July 2018
- Terminated
- 24 January 2023
- Reason
- Bubble Leak Testing on AbViser AutoValve IAP Monitoring Devices without Transducer confirmed the potential for a pinhole breach in the sterile barrier.
- Distribution
- worldwide Distribution: US (nationwide) and countries of: Australia, Austria, Canada, Bahrain, Bangladesh, Belgium, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hungary, India, Israel, Italy, Kenya, Kuwait, Malta, Mauritius, Netherlands,Norway, Portuga
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2744-2018
- AbViser AutoValve IAP (intra- abdominal pressure) Monitoring Device, Patient mount: a) REF ABV300, b) REF ABV301 AbViser is a sterile non-invasive disposable intra- abdominal pressure monitoring device containing asp
Terminated Class II Medical devices
- Recall started
- 25 April 2018
- Terminated
- 27 February 2023
- Reason
- 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.
- Distribution
- US Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1890-2018
- Convatec Esteem(TM) Synergy Stomahesive(R), 7/8 in. / 22mm, REF 405475 Product Usage: Esteem Synergy Stomahesive with Flexible Collar 22mm Precut Skin Barrier is used together with Esteem Synergy pouches as an ostomy
Terminated Class II Medical devices
- Recall started
- 26 October 2017
- Terminated
- 3 February 2023
- Reason
- A portion of Lot 7H02242 outer boxes (market units) of the SUR-FIT Natura Moldable Durahesive Skin Barrier (10 pack, 45 mm, REF 411802) were incorrectly labeled as Natura Moldable Stomahesive Skin Barrier (10 pack, 45 mm, REF 411803).
- Distribution
- Nationwide Distribution - AK, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, and WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0525-2018
- SUR-FIT Natura Moldable Durahesive Skin Barrier with Hydrocolloid Flexible Collar, 10 pack, 45 mm, REF 411802. Intended for use as an ostomy protector providing a protective barrier to patient skin.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.