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Lower risk Medical device recall · FDA · Published April 22, 2022

ConvaT: SUR-FIT Natura S4S Wafer Skin Barrier Issues

ConvaTec recalls SUR-FIT Natura S4S 70mm wafers due to skin barrier delamination and tape tears reported in 10 complaints. Affected units have specific lot numbers and expiration dates.

🇺🇸 FDA recall #Z-1134-2022Medical deviceConvaTec ›
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Recalling firmConvaTec, Inc7815 National Service Rd Ste 600 · Greensboro, NC 27409-9403
✎ GovInfoNow plain-language explainer

ConvaTec is recalling SUR-FIT Natura S4S 70mm adhesive wafers after 10 complaints reported skin barrier issues like flange lifts or tape tears. This could lead to discomfort or skin irritation if the product fails to stay securely attached. Read more at govinfonow.com/recall/60768-convat-sur-fit-natura-s4s-wafer-skin-barrier-issues.

Source Summary by GovInfoNow · govinfonow.com/recall/60768-convat-sur-fit-natura-s4s-wafer-skin-barrier-issues · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1134-2022

Cite this page

“ConvaT: SUR-FIT Natura S4S Wafer Skin Barrier Issues.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60768-convat-sur-fit-natura-s4s-wafer-skin-barrier-issues. Based on FDA recall #Z-1134-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1134-2022%22&limit=1).

ConvaTec, Inc. voluntarily recalled SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US on April 22, 2022, according to the FDA. The recall addresses skin barrier delamination and tape border rips reported in 10 complaints.

How to tell if you have it

  • Brand: ConvaTec
  • Product: SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US
  • Order Number: ICC 413157
  • Lot Number: 1H02899
  • Expiration Date: Aug 2026
  • DI Number: 00768455106189

The hazard

The firm received 10 complaints of skin barrier delamination issues, such as flange lifting from the wafer or skin barrier layers separating, or tape border rips and tears. The FDA classified this recall as Class II.

Context

GovInfoNow's records show ConvaTec, Inc. has 17 other recalls on record since Oct. 26, 2017. Other recent recalls of similar products include ConvaTec Esteem Body Soft Urostomy Pouches (July 6, 2026), ConvaTec Aquacel Ag Surgical SP Dressings (June 8, 2026), and ConvaT: EsteemBody Drainable Pouch Leak Recall (Feb. 16, 2026). Other recent recalls of similar products include Mastisol Skin Adhesive Recall (Jan. 15, 2026) and Medtronic DLP Retrograde Cannula Recall (April 21, 2026).

How to tell if you have this one

Check for the product name SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each unit contains 10 wafers. Look for lot number 1H02899 and expiration date August 2026.

  • Brand
    ConvaTec
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Verify the product name, lot number 1H02899, and expiration date August 2026 to confirm if your item is affected.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 19 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: nationwideWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: named in the noticeKYWest Virginia: nationwideWVVirginia: named in the noticeVAMaryland: nationwideMDDelaware: named in the noticeDEArizona: nationwideAZNew Mexico: nationwideNMKansas: named in the noticeKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: named in the noticeNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: nationwideGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, California, Delaware, Florida, Illinois, Kansas, Kentucky, Louisiana, Michigan, Minnesota, Mississippi, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Texas, Virginia, Washington.

Recall timeline

FDA terminated this recall 3.9 years after the firm started it.

1. Firm started the recall: Apr 22, 202212. FDA classified it Class II: May 25, 202223. Published in FDA’s Enforcement Report: Jun 1, 202234. FDA terminated the recall: Mar 4, 2026420222026
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. 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-1134-2022 (April 22, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1134-2022 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA