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Convatec, Ltd.

Also registered as Convatec, Convatec Limited, Convatec, Inc.

United Statesfrom the FDA registration address FDA FEI 3011987967

Devices
28
Registrations
FDA
FDA recalls
7217 ongoing since 2021 (21 open in total)
4 open since before 2021

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA establishment, FDA recalls

What Convatec, Ltd. makes

Convatec, Ltd. manufactures wound care dressings, including hydroactive and gel-formula products designed for skin protection and healing, as well as intermittent urinary catheters for male patients. Their portfolio also includes a fecal management system with signal detection for incontinence support.

The company’s products are regulated under FDA 510(k) clearance for Class II devices and Class U (custom devices) in the United States. These items are listed in the FDA’s 510(k) registry.

AI-generated from registry data, 4 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue28

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Company details

FDA FEI number
3011987967
Address
7815 National Service Road, Greensboro, NC, 27409

FDA recalls72

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

Recalls initiated per year

  • 2017 19
  • 2018 2
  • 2019 5
  • 2020 0
  • 2021 2
  • 2022 6
  • 2023 0
  • 2024 4
  • 2025 1
  • 2026 5

28 initiated before 2017

Showing the 10 most recent of 72 recalls.

  • 2026

    • 6 Jul 2026 Z-2986-2026 Class II Ongoing Urostomy Pouches may leak from cap during use.via FDA establishment CONVATEC LIMITED 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,…
      Full distribution text 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.
    • 8 Jun 2026 Z-2677-2026 Class II Ongoing Surgical dressing manufactured out of specification (greater thickness).via FDA establishment CONVATEC LIMITED 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,…
      Full distribution text 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.
      Submission number: K152926
    • 16 Feb 2026 Z-1582-2026 Class II Ongoing Drainable large pouch may leak due to manufacturing issue.via FDA establishment CONVATEC LIMITED Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Canada, China, Czech Republic, Denmark, Finland,…
      Full distribution text 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.
    • 16 Feb 2026 Z-1583-2026 Class II Ongoing Drainable large pouch may leak due to manufacturing issue.via FDA establishment CONVATEC LIMITED Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Canada, China, Czech Republic, Denmark, Finland,…
      Full distribution text 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.
    • 16 Feb 2026 Z-1584-2026 Class II Ongoing Drainable large pouch may leak due to manufacturing issue.via FDA establishment CONVATEC LIMITED Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Canada, China, Czech Republic, Denmark, Finland,…
      Full distribution text 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.

  • 2025

    • 29 Aug 2025 Z-0160-2026 Class II Ongoing Wound dressing may have foreign matter on the product.via FDA establishment CONVATEC LIMITED 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,…
      Full distribution text 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.

  • 2024

    • 29 Nov 2024 Z-0903-2025 Class II Ongoing 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 bleedingvia FDA establishment CONVATEC LIMITED Distribution: US distribution to states of: OH, NY, IL
    • 27 Feb 2024 Z-1495-2024 Class II Ongoing The product does not meet sterility assurance level.via FDA establishment CONVATEC LIMITED Distribution: US Nationwide distribution in the states of CA, MO, NM, PA, TX, and WA.
    • 19 Feb 2024 Z-1350-2024 Class II Ongoing 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.via FDA establishment CONVATEC LIMITED Distribution: Worldwide distribution - US Nationwide and the countries of Italy, UK.
    • 17 Jan 2024 Z-1276-2024 Class II Ongoing The kit contains a flange that has a 45mm coupling ring, however, the pouch within the kit is for a 57mm coupling ring.via FDA establishment CONVATEC LIMITED Distribution: Distribution was made to AK, CA, FL, IL, IN, MI, NE, NJ, NY, OH, PA, and TX. There was government distribution but no…
      Full distribution text 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.
Show the 25 most recent of 72 recalls

  • 2022

    • 15 Nov 2022 Z-0723-2023 Class II Ongoing 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.via FDA establishment CONVATEC LIMITED Distribution: US Nationwide distribution. Submission number: K123481
    • 16 Aug 2022 Z-0127-2023 Class II Ongoing impaired functionality of the release linervia FDA establishment CONVATEC LIMITED Distribution: US Nationwide distribution.
    • 16 Aug 2022 Z-0128-2023 Class II Ongoing impaired functionality of the release linervia FDA establishment CONVATEC LIMITED Distribution: US Nationwide distribution.
    • 16 Aug 2022 Z-0129-2023 Class II Ongoing impaired functionality of the release linervia FDA establishment CONVATEC LIMITED Distribution: US Nationwide distribution.
    • 16 Aug 2022 Z-0130-2023 Class II Ongoing impaired functionality of the release linervia FDA establishment CONVATEC LIMITED Distribution: US Nationwide distribution.
    • 22 Apr 2022 Z-1134-2022 Class II Terminated Firm received 10 complaints of skin barrier delamination issues (e.g. flange lifts from wafer, skin barrier layers separate) or tape border rips/tears.via FDA establishment CONVATEC LIMITED 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…
      Full distribution text 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.

  • 2021

    • 20 Aug 2021 Z-2614-2021 Class II Ongoing Primary packaging labeling may be incorrect.via FDA establishment CONVATEC LIMITED Distribution: Distribution in US and Canada US distribution in CA, FL, GA, IL, MD, MN, NC. NM, NJ, OH, PA, TX, VA
    • 9 Aug 2021 Z-2519-2021 Class II Ongoing There is a potential for open seals which can compromise sterility.via FDA establishment CONVATEC LIMITED Distribution: International distribution to the countries of Argentina, Aruba, Australia, Bonaire, Brazil, Canada, Chile, , Colombia,…
      Full distribution text 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, , Pakistan, Paraguay, Qatar, Singapore, South Korea, Switzerland, Taiwan, Thailand, UAE, Uruguay, USA and Vietnam.

  • 2019

    • 6 Sep 2019 Z-0233-2020 Class II Terminated 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.via FDA establishment CONVATEC LIMITED Distribution: Worldwide distributions.
    • 9 Jan 2019 Z-1035-2019 Class II Open since 2019 An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.via FDA establishment CONVATEC LIMITED Distribution: Worldwide Distribution - US Nationwide in the states of IL, MI, PA, WI. and the countries of Algeria, Australia,…
      Full distribution text 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, Korea, Kuwait, Lebanon, Myanmar, Netherlands, New Zealand, Norway, Poland, Qatar, Singapore, Spain, Slovakia, South Africa, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom, United States, Vietnam.
    • 9 Jan 2019 Z-1036-2019 Class II Open since 2019 An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.via FDA establishment CONVATEC LIMITED Distribution: Worldwide Distribution - US Nationwide in the states of IL, MI, PA, WI. and the countries of Algeria, Australia,…
      Full distribution text 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, Korea, Kuwait, Lebanon, Myanmar, Netherlands, New Zealand, Norway, Poland, Qatar, Singapore, Spain, Slovakia, South Africa, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom, United States, Vietnam.
      Submission number: K896734
    • 9 Jan 2019 Z-1037-2019 Class II Open since 2019 An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.via FDA establishment CONVATEC LIMITED Distribution: Worldwide Distribution - US Nationwide in the states of IL, MI, PA, WI. and the countries of Algeria, Australia,…
      Full distribution text 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, Korea, Kuwait, Lebanon, Myanmar, Netherlands, New Zealand, Norway, Poland, Qatar, Singapore, Spain, Slovakia, South Africa, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom, United States, Vietnam.
      Submission number: K896729
    • 9 Jan 2019 Z-1038-2019 Class II Open since 2019 An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.via FDA establishment CONVATEC LIMITED Distribution: Worldwide Distribution - US Nationwide in the states of IL, MI, PA, WI. and the countries of Algeria, Australia,…
      Full distribution text 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, Korea, Kuwait, Lebanon, Myanmar, Netherlands, New Zealand, Norway, Poland, Qatar, Singapore, Spain, Slovakia, South Africa, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom, United States, Vietnam.

  • 2018

    • 3 Jul 2018 Z-2744-2018 Class II Terminated Bubble Leak Testing on AbViser AutoValve IAP Monitoring Devices without Transducer confirmed the potential for a pinhole breach in the sterile barrier.via FDA establishment CONVATEC LIMITED Distribution: worldwide Distribution: US (nationwide) and countries of: Australia, Austria, Canada, Bahrain, Bangladesh, Belgium,…
      Full distribution text 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, Portugal, Qatar, Romania, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United Arab Emirates, and Vietnam.
    • 25 Apr 2018 Z-1890-2018 Class II Terminated 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.via FDA establishment CONVATEC LIMITED Distribution: US Nationwide Distribution

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • Convatec Limited Deeside Flintshire · GB FEI 1000317571

Frequently asked questions

How many devices does Convatec, Ltd. have in the registry?

The registry currently lists 28 devices for Convatec, Ltd.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Convatec, Ltd.'s devices?

Among its 28 most recently registered devices, Convatec, Ltd. has devices listed in FDA 510(k) (28 devices).

What risk classes do Convatec, Ltd.'s devices fall under?

Among its 28 most recently registered devices, the classes recorded for Convatec, Ltd.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Convatec, Ltd.?

FDA recall records list 72 recalls initiated by Convatec, Ltd., the most recent initiated on 6 Jul 2026. 21 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Convatec, Ltd. in the registry?

The most recently registered devices listed for Convatec, Ltd. include AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber, AQUACEL Ag Surgical SP Dressing, VITALA CONTINENCE CONTROL DEVICE and GentleCath Glide Intermittent Catheter.

Which FDA establishments are linked to Convatec, Ltd.?

1 FDA establishment is linked to Convatec, Ltd. in the registry; they are listed on the company page.

Generated automatically from registry data and not verified by a human reviewer.