CLASS II Device recall · Reported 1 Jun 2022 · FDA Enforcement Report

Sur-fit Natura S4S Durahesive Wafer (1X10PK) US recalled by ConvaTec

ConvaTec is recalling Sur-fit Natura S4S Durahesive Wafer (1X10PK) US. Each market unit contains 10 individual, distributed nationwide in the US. The recall was initiated on 22 Apr 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct order number: ICC 413157; LOT Number 1H02899; Expiration Date: Aug 2026; DI Number: 00768455106189

Quantity recalled600 market units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1134-2022
FDA event ID: 90041
Recalling firm: ConvaTec, Greensboro, NC
Classification: Class II
Status: Terminated
Recall initiated: 22 Apr 2022
FDA classified: 25 May 2022
Reported: 1 Jun 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

22 Apr 2022	Recall initiated by company
25 May 2022	Classified by FDA	+33 days
1 Jun 2022	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Firm received 10 complaints of skin barrier delamination issues (e.g. flange lifts from wafer, skin barrier layers separate) or tape border rips/tears.

Product as listed by the FDA

SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10 individual wafers.

Where it was distributed

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.

Nationwide Alabama California Delaware Florida Illinois Kansas Kentucky Louisiana Michigan Minnesota Mississippi North Carolina New Jersey New York Ohio Pennsylvania Texas Virginia Washington

Questions about this recall

Why was it recalled?

Firm received 10 complaints of skin barrier delamination issues (e.g. flange lifts from wafer, skin barrier layers separate) or tape border rips/tears.

Which lots are affected?

Product order number: ICC 413157; LOT Number 1H02899; Expiration Date: Aug 2026; DI Number: 00768455106189

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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