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.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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…
- 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.
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