Ethicon Recalls LIGACLIP Endoscopic Clip Appliers Due to Clip Formation Issues
Ethicon Endo-Surgery is voluntarily recalling LIGACLIP 10mm M/L Endoscopic Rotating Multiple Clip Appliers due to potential clip formation and feeding issues that may cause vessel damage.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of significant injury, specifically vessel damage and insufficient occlusion, which aligns with the rubric criteria for a Severe rating.
Plain-English summary
Ethicon Endo-Surgery is initiating a voluntary recall of the LIGACLIP 10mm M/L Endoscopic Rotating Multiple Clip Applier (ER320). The recall involves 10,488 units of the bulk non-sterile instrument, which is a single-patient-use device designed to provide a means of ligation through ENDOPATH surgical trocars. The instrument delivers 20 titanium clips and is designed to rotate 360 degrees in either direction.
The recall is being conducted due to potential clip formation and feeding issues. These defects may result in improper clip formation, vessel damage, and/or insufficient occlusion of the vessel or other structure. The affected products were distributed worldwide, including nationwide to all fifty U.S. states and internationally to numerous countries such as Canada, Mexico, and various nations in Europe, Asia, and South America.
Healthcare providers and facilities that have received these devices should stop using them and contact Ethicon Endo-Surgery for instructions on how to return the product. The source text does not specify a particular action for individual consumers, as this is a professional medical device intended for use by trained medical personnel.
The recalled product
- Product
- LIGACLIP¿ Endoscopic Rotating Multiple Clip Applier (ER320), 10mm M/L, bulk non-sterile Product Usage: The LIGACLIP Endoscopic Rotating Multiple Clip Applier is a single patient use instrument designed to provide a means of ligation through ENDOPATH¿ surgical trocars. The ins
- Manufacturer
- Ethicon Endo-Surgery Inc
- Affected units
- 10,488
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 (3)
- CK017
- 02
- 2016-11 to 2018-03
Distribution
Part of a larger recall action
This product is one of 3 recalled by Ethicon Endo-Surgery Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Ethicon Endo-Surgery Inc
See all →- HighLinear cutter reloads recalled after devices were shipped unsterilized
FDA (Devices) · 2025-10-22
- CriticalEndopath Echelon Vascular White Reload surgical stapler device lockout
FDA (Devices) · 2025-05-28
- HighEndoscopic Surgical Stapler Reload May Fail to Form Complete Staple Line
FDA (Devices) · 2024-02-07
- HighSurgical Shears HARMONICHD 1000i Recalled Due to Component Defect and Burn Risk
FDA (Devices) · 2021-09-01
- HighHARMONIC HD 1000i Surgical Shears Recalled for Potential Burn Risk
FDA (Devices) · 2021-09-01
Same hazard · vessel damage
See all →- HighAneurysm Embolization System Detachment Controller Recalled for Manufacturing Defect
FDA (Devices) · 2022-11-09
- HighOptima Coil System Recalled for Labeling and Packaging Mix-Up
FDA (Devices) · 2022-03-02
- CriticalPenumbra JET 7 Reperfusion Catheter Recalled for Potential Tip Damage
FDA (Devices) · 2021-01-27
- CriticalPenumbra JET 7MAX Kits Recalled for Potential Vessel Damage Risk
FDA (Devices) · 2021-01-27
- CriticalPenumbra JET 7 Reperfusion Catheter Recalled for Potential Vessel Damage
FDA (Devices) · 2021-01-27