Agency classClass IIOur severity:High FDA (Devices)·Z-1776-2013·Announced 2013-07-31

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 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: The recall involves a medical device with a risk of harm (vessel damage and insufficient occlusion) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products.

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 49,357 units of the sterile, single-patient-use instrument, which is designed to provide a means of ligation through surgical trocars and delivers 20 titanium clips.

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 nationwide to all fifty states and internationally to numerous countries.

Healthcare providers and facilities should stop using the affected LIGACLIP Endoscopic Rotating Multiple Clip Appliers immediately. Ethicon Endo-Surgery is the recalling firm and is managing the recall process for these specific product codes and lots.

The recalled product

Product: LIGACLIP¿ Endoscopic Rotating Multiple Clip Applier Convenience Kit (Flex Trays), 10mm M/L Product Usage: The LIGACLIP Endoscopic Rotating Multiple Clip Applier is a sterile, single patient use instrument designed to provide a means of ligation through ENDOPATH¿ surgical…
Manufacturer: Ethicon Endo-Surgery Inc
Category: Medical Device — Surgical Instrument
Hazard: device-malfunction
vessel-damage
Affected units: 49,357

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 (20)

FNC40XL
41
2017-09 to 2018-01
FNC41XL
2016-12 to 2018-02
FNC41XLD
FNC42XL
FNC43XL
FNC43XLD
2017-02 to 2018-02
KBC17XL
2016-12 to 2018-2
KNC03XL
2017-02 to 2017-06
42
2017-09 to 2017-10
43
2017-10
KNC07XL
2017-01 to 017-05

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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 →

Same manufacturer · Ethicon Endo-Surgery Inc

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