Instinct Plus endoscopic clipping devices may malfunction during use
The Instinct Plus Endoscopic Clipping Device is being recalled after increased complaints indicating the device has the potential to malfunction. 713,702 units are affected.
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: FDA Class II recall where a device used to close gastrointestinal defects may malfunction, a risk of harm with no injuries reported in the source.
Plain-English summary
The Instinct Plus Endoscopic Clipping Device, REF G58010, is being recalled. The action covers 713,702 units across all lots manufactured between 2 September 2023 and 20 April 2025, UDI 10827002580104.
The recall follows an increase in complaints indicating there is the potential for the endoscopic clipping device to malfunction. The FDA classified the action as Class II.
Distribution was worldwide, including nationwide in the United States across a large number of states. The devices are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the REF number, UDI and manufacturing date range above, quarantine it, and follow the instructions issued by the manufacturer.
The recalled product
- Product
- Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EO
- Manufacturer
- Wilson-Cook Medical Inc.
- Affected units
- 713,702
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 (2)
- All Lots manufactured between 9/2/2023-04/20/2025
- UDI: (01)10827002580104
Distribution
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