SUR-FIT Natura Durahesive Wafer Recalled for Skin Barrier Delamination
ConvaTec is recalling 600 market units of SUR-FIT Natura S4S Durahesive Wafer due to skin barrier delamination. The wafer's layers or tape borders may fail to maintain proper seal, potentially affecting skin protection.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA medical device recall involving a structural failure (delamination) of a critical skin barrier product with 10 reported cases of device failure. Although no illnesses or injuries have been reported, the device failure creates a risk of impaired skin protection and potential complications, meeting the High severity criterion for risk-of-harm products without reported injury.
Plain-English summary
ConvaTec, Inc is recalling SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK), a skin barrier medical device used in ostomy and wound care. Each market unit contains 10 individual protective wafers. The company initiated the recall due to 10 reported cases of skin barrier delamination, in which the flange lifts from the wafer, the barrier's protective layers separate, or tape borders develop rips and tears. These structural failures could prevent the wafer from maintaining a proper seal and protecting the skin.
The recall covers 600 market units with product order number ICC 413157 and lot number 1H02899 (expiration date August 2026). The affected product was distributed nationwide to the following states: New Jersey, Pennsylvania, Ohio, California, Alabama, Michigan, New York, Texas, Florida, North Carolina, Virginia, Louisiana, Illinois, Delaware, Kentucky, Washington, Kansas, Minnesota, and Mississippi, as well as internationally to India.
Consumers and healthcare providers in possession of the affected lot should discontinue use of the product. Customers are encouraged to contact ConvaTec, Inc regarding replacement or refund options. Anyone experiencing skin integrity issues potentially related to use of this product should report the incident to the FDA through its MedWatch program.
The recalled product
- Product
- SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10 individual wafers.
- Manufacturer
- ConvaTec, Inc
- Hazard
- delamination
- seal-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Product order number: ICC 413157
- LOT Number 1H02899
- Expiration Date: Aug 2026
- DI Number: 00768455106189
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighSurgify Halo surgical drill recalled for potential burr breakage
FDA (Devices) · 2026-07-01
- SevereDa Vinci surgical system operative components with E-brake retainer pin defect
FDA (Devices) · 2026-07-01
- SevereMedline angiography and radiology convenience kits recalled for unapproved design changes
FDA (Devices) · 2026-07-01
- SevereMedical Device Surgical Kits with Syringes Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01
- SevereMedline convenience kits recalled for unapproved syringe design changes
FDA (Devices) · 2026-07-01