ConvaTec Convex Two-Piece Ostomy Skin Barriers: Off-Center Starter Hole Risk
ConvaTec recalls Convex Two-Piece Ostomy Skin Barriers (brands: Combihesive Natura Durahesive, SurFit Natura Durahesive, Natura, Varicare) manufactured Feb 2017-Sep 2018 due to off-center starter hole causing potential stoma misalignment.
Use caution until it’s fixed
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.
Contact the company
What happened, in plain English
ConvaTec is recalling certain Convex Two-Piece Ostomy Skin Barriers made between February 2017 and September 2018 because the starter hole (stoma hole) may be off-center. This could lead to improper stoma alignment and complications during use. Read more at govinfonow.com/recall/67064-convatec-convex-two-piece-ostomy-skin-barriers-off-center-starter.
Source Summary by GovInfoNow · govinfonow.com/recall/67064-convatec-convex-two-piece-ostomy-skin-barriers-off-center-starter · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0233-2020
Cite this page
“ConvaTec Convex Two-Piece Ostomy Skin Barriers: Off-Center Starter Hole Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/67064-convatec-convex-two-piece-ostomy-skin-barriers-off-center-starter. Based on FDA recall #Z-0233-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0233-2020%22&limit=1).
Why it’s dangerous
The starter hole (stoma hole) may be off-center on products made between February 2017 and September 2018. This could cause improper alignment of the stoma with the skin barrier, potentially leading to leaks, skin irritation, or infection.
Who’s affected
People using these ostomy skin barriers for stoma management are affected. Those with existing stomas or who have recently had stoma surgery are at higher risk.
How to tell if you have this one
Check for the product names: Combihesive Natura Durahesive, SurFit Natura Durahesive, Natura, or Varicare. Look for the specific product codes and lot numbers listed in the recall notice.
- Brand
ConvaTec- Category
Medical device
What to do — step by step
Check Product Details
Review the product codes and lot numbers listed in the recall notice to confirm if your item is affected.
How this recall unfolded
Recall timeline
FDA terminated this recall 3.2 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0233-2020 (September 6, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0233-2020 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.