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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
Related recalls
Same manufacturer · Wilson-Cook Medical Inc.
See all →- ModerateWilson-Cook Recalls Hemospray Endoscopic Hemostat Due to Adherence Issues
FDA (Devices) · 2026-09-23
- SevereWilson-Cook Medical Recalls Teslatome Bipolar Sphincterotomes Over Current Path Risk
FDA (Devices) · 2026-02-25
- ModerateNasal jejunal feeding tubes recalled without the nasal transfer tube
FDA (Devices) · 2026-02-11
- HighCook Medical HEMO-7-EU Hemospray Devices Recalled for Activation Knob Defect
FDA (Devices) · 2024-12-11
- HighWilson-Cook Medical Recalls Hemo-7 and Hemo-10 Hemospray Endoscopic Hemostats
FDA (Devices) · 2024-10-23
Same hazard · device malfunction
See all →- SevereJenaValve Trilogy Delivery Catheter Recalled for Sleeve Liner Separation
FDA (Devices) · 2026-10-21
- SevereJenaValve Trilogy Delivery Catheter Recalled for Sleeve Liner Separation
FDA (Devices) · 2026-10-21
- SevereJenaValve Trilogy Delivery Catheter Recalled for Sleeve Liner Separation
FDA (Devices) · 2026-10-21
- ModerateMedline recalls CONMED AirSeal Access Port kits due to pressure alert issues
FDA (Devices) · 2026-10-21
- ModerateMedline Recalls Convenience Kits Containing CONMED AirSeal Access Ports
FDA (Devices) · 2026-10-21
Similar recalls
- HighCapso Vision Recalls CapsoCAM Plus Capsule Endoscopy Systems
FDA (Devices) · 2020-05-06
- HighIntuitive Surgical Recalls 8mm Clip Appliers Due to Reprocessing Deviations
FDA (Devices) · 2014-12-03
- HighIntuitive Surgical Recalls 8mm Large Hem-O-Lok Clip Applier Devices
FDA (Devices) · 2014-12-03
- HighUS Endoscopy Recalls Histolock Resection Device Due to Sterility Concerns
FDA (Devices) · 2015-10-07
- HighIntuitive Surgical Recalls 8mm Atrial Retractor Instruments Due to Reprocessing Deviations
FDA (Devices) · 2014-12-03
- ModerateIntuitive Surgical Recalls 8mm Small Grasping Retractor for Reprocessing Deviations
FDA (Devices) · 2014-12-03