Two lots of the BiCOAG Hemostasis Probe are being recalled in South Africa after Olympus, the original equipment manufacturer, determined that affected models may have been manufactured without the designated amount of adhesive at the rear of the ceramic tip, which may result in the tip detaching.
Endoscopy units and theatre stores must stop using and distributing the affected lots immediately, check internal inventory and quarantine stock. The device is used for coagulation of active bleeding lesions in the upper or lower gastrointestinal tract during endoscopic procedures, so a detached ceramic tip would be released into the GI tract during a procedure being performed on a patient who is already bleeding. Units should also consider whether any procedures were performed using these lots.
| Lot | Expiry | First distributed |
|---|---|---|
| KR313754 | 18/10/2026 | 15 February 2024 |
| KR313735 | 06/10/2026 | 16 January 2025 |
The recall is classified Class II Type C and dated 28 August 2026. It is being conducted by Surgical Innovations (Pty) Ltd of Randburg in consultation with the South African Health Products Regulatory Authority, on behalf of the manufacturer. Both lots are supplied as single units and expire in October 2026.
Source: https://www.sahpra.org.za/document/bicoag-hemostasis-probe/
