The South African Health Products Regulatory Authority (SAHPRA) has issued a Class II Type C recall for batch 5L00431 of Esenta Stomahesive Paste.
Adcock Ingram Critical Care (Pty) Ltd, the local distributor, initiated the recall after manufacturer Convatec identified a quality issue involving potential foreign matter in a limited number of units from the affected batch. The presence of foreign matter may affect the quality and intended performance of the medical device.
Healthcare professionals and distributors must immediately quarantine and isolate all remaining stock from batch 5L00431 and discontinue any further distribution, sale, dispensing or use of the product. Affected units should be returned to Adcock Ingram Critical Care for collection.
The recalled product is Esenta Stomahesive Paste, supplied as one tube of 56.7 g, with expiry date 01 November 2030. The batch was first distributed on 27 August 2026. The recall was classified Class II Type C and dated 28 October 2026.
The authority did not state what type of foreign matter was identified, how many units were affected, the quantity distributed, or whether any non-serious adverse events have been reported.
Sources
- Primary: South African Health Products Regulatory Authority (SAHPRA), “Esenta Stomahesive Paste”, 28 October 2026: https://www.sahpra.org.za/document/esenta-stomahesive-paste/
