The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1775-2013·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 because potential clip formation and feeding issues may cause vessel damage or insufficient occlusion.

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 defect that may result in vessel damage or insufficient occlusion, which poses a risk of harm to patients. However, the source text does not report any specific injuries, hospitalizations, or deaths, and the agency classification is Class II, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

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 is 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 units were distributed worldwide, including nationwide to all fifty U.S. states and internationally to numerous countries. The source text lists specific lot codes and expiration dates ranging from 2012 to 2017 for the affected inventory.

Healthcare providers and facilities should check their inventory for the specific lot codes listed in the official recall notice. If the product is found, it should be removed from service and returned to Ethicon Endo-Surgery or their authorized representative according to the instructions provided in the recall communication.

The recalled product

Product
LIGACLIP¿ Endoscopic Rotating Multiple Clip Applier (ER320), 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 trocars. The instrument…
Manufacturer
Ethicon Endo-Surgery Inc
Category
Medical Device — Surgical Instruments
Hazard
Affected units
738,356

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)

  • H44Z7W
  • 37ER320
  • 01/03/12 to 11/15/16
  • J4A016
  • 01/05/12 to 12/15/16
  • J4A11G
  • 01/10/12 to 12/15/16
  • J4A124
  • J4A145 37ER320
  • 01/11/12 to 12/15/16 J4A182
  • 01/13/12 to 12/15/16
  • J4A21T
  • 01/27/12 to 12/15/16
  • J4A28D
  • 01/19/12 to 12/15/16
  • J4A28U
  • J4A335
  • 01/23/12 to 12/15/16
  • J4A38L
  • 01/25/12 to 12/15/16

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 →

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