ConvaTec SUR-FIT Natura Skin Barrier Recall: Incorrect Labeling Risk
ConvaTec recalls 10-pack SUR-FIT Natura Moldable Durahesive Skin Barrier (REF 411802) due to incorrect labeling with a different product. Affected units were shipped in Lot 7H02242.
Lower-risk recall
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).
Contact the company
What happened, in plain English
ConvaTec is recalling 10-pack SUR-FIT Natura Moldable Durahesive Skin Barrier products (REF 411802) because some units were incorrectly labeled as a different product. This labeling error means users might be using the wrong product, which could cause confusion or incorrect application. Read more at govinfonow.com/recall/72657-convatec-sur-fit-natura-skin-barrier-recall-incorrect-labeling-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/72657-convatec-sur-fit-natura-skin-barrier-recall-incorrect-labeling-risk · Updated September 14, 2026 · FDA enforcement record: FDA #Z-0525-2018
Cite this page
“ConvaTec SUR-FIT Natura Skin Barrier Recall: Incorrect Labeling Risk.” GovInfoNow, updated September 14, 2026. https://govinfonow.com/recall/72657-convatec-sur-fit-natura-skin-barrier-recall-incorrect-labeling-risk. Based on FDA recall #Z-0525-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0525-2018%22&limit=1).
Why it’s dangerous
The product was incorrectly labeled as a different type of skin barrier (Natura Moldable Stomahesive Skin Barrier) in some outer boxes. This labeling error could lead to users applying the wrong product, which might not fit properly or provide the intended protection for ostomy care.
Who’s affected
People who own or use the SUR-FIT Natura Moldable Durahesive Skin Barrier (10 pack, 45 mm, REF 411802) from Lot 7H02242 are affected. Those with ostomy care needs are most at risk due to potential confusion with the incorrect product.
How to tell if you have this one
Check if your SUR-FIT Natura Moldable Durahesive Skin Barrier (10 pack, 45 mm, REF 411802) was shipped in Lot 7H02242. The incorrect label shows REF 411803 instead of REF 411802.
- Brand
ConvaTec- Category
Medical device
What to do — step by step
Check Product Label
Look for the product reference code on the outer box: REF 411802 for the correct product or REF 411803 for the incorrectly labeled item.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 37 states.
FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alaska, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Vermont, Virginia, Washington, Wisconsin.
Recall timeline
FDA terminated this recall 5.3 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.
Questions people ask
Is this product dangerous if used incorrectly?
The recall is due to labeling error, not a safety hazard. The product itself is safe but may be misapplied if the wrong product is used.
Similar recalls
Latest medical device recalls
Keep exploring
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-0525-2018 (October 26, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0525-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 14, 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.