FDA Medical Device Recalls (openFDA)
ConvaTec, Inc: SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10 individual wafers.
- Recall number
- Z-1134-2022
- Recalling firm
- ConvaTec, Inc
- Product
- SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10 individual wafers.
- Status
- Terminated
- Initiated
- 2022-04-22
- Posted
- not on file
- Terminated
- 2026-03-04
- Reason
- Firm received 10 complaints of skin barrier delamination issues (e.g. flange lifts from wafer, skin barrier layers separate) or tape border rips/tears.
- Root cause
- Under Investigation by firm
- Action
- The consignee recall notification was sent out via the United Pacel Service on 04/22/2022. The letter instructs the consignee to not use the product and complete the recall response form. The consignee should call the toll-free number to arrange a return.
- Quantity
- 600 market units
- 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.
- Lot, serial or model codes
- Product order number: ICC 413157; LOT Number 1H02899; Expiration Date: Aug 2026; DI Number: 00768455106189
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- EXE
- Firm FEI
- 3011987967
- Firm city
- Greensboro
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28