Field Safety Notice issued for Convatec ESENTA Stomahesive Paste

Last Updated on 21/10/2026 by Sarah Sarsby

BHTA member Convatec is voluntarily recalling specific lots of ESENTA Stomahesive Paste due to the potential presence of foreign matter.

The Field Safety Notice, dated October 2026 and carrying reference TW-3258356, requires affected products to be identified, quarantined, and removed from use and distribution.

What has been identified?

Convatec’s investigation found that controls at a third-party manufacturing facility were not fully effective in preventing contamination of its materials.

Foreign matter may affect product quality and performance. Potential adverse effects include local inflammatory response, minor infection, skin irritation, rash, mucosal irritation, or allergic reaction.

At the time of the notice, Convatec had received no reports of related adverse events. One customer complaint involving foreign matter prompted the investigation and corrective action.

Which products are affected?

The recall covers multiple product codes and lots internationally. The table below lists only the UK-specific products identified in Appendix 2, all supplied in 60g tubes.

Readers should consult the full Convatec Field Safety Notice for the global affected product list and country-specific details. Appendix 3 shows how to identify product information on the packaging.

What should distributors do?

Distributors and healthcare facilities should check inventory without undue delay and immediately quarantine affected stock, stopping its distribution, sale, transfer, and use.

Relevant personnel must be informed. Distributors should immediately identify and notify customers supplied with affected products, retain notification records, and confirm completion upon request.

The Appendix 1 response form must be returned to European.CustomerSupport@convatec.com within 30 days, even if no affected stock is held.

Convatec will provide a Certificate of Destruction where affected inventory is identified; this must be signed and returned following destruction. Organisations that purchased through another supplier should contact that supplier for disposal instructions.

What should Convatec sales representatives do?

Sales representatives should immediately familiarise themselves with the notice and affected lots, stop distribution and promotion of affected products, and check personal stock, consignment stock, and demonstration kits.

They must return the Appendix 1 response form to European.CustomerSupport@convatec.com within 30 days and complete and return a Certificate of Destruction.

Representatives should support customers with stock identification where requested and escalate complaints, quality concerns, potential adverse events, and customer questions through established Convatec processes.

What should users do?

Users and patients should stop using affected products immediately, set them aside, and contact their healthcare provider, supplier, pharmacy, or Convatec representative. Users should keep the product details and lot number until they receive further instructions.

Anyone experiencing unexpected symptoms after using affected product, including irritation, rash, inflammation, or signs of infection, should contact their healthcare professional promptly.

What should healthcare professionals do?

Healthcare professionals should identify, quarantine, and dispose of affected products, discontinue their use, inform relevant staff, and report adverse events or complaints to Convatec and applicable regulatory authorities as required.

Convatec has received no reports indicating that patient intervention is required solely because of this issue. Professionals should use clinical judgement when assessing potentially exposed patients.

Further information

The notice must be shared with relevant internal recipients and organisations supplied with potentially affected products.

Appendix 4 of the FSN lists country-specific contacts for customer services and replacement product enquiries. In the UK, contact uk.customerservice@convatec.com or 01244 284882.

Questions about the field action can be sent to fsca-id@convatec.com.