The Recall Desk
HighFDA (Devices)·Z-1530-2013·Announced 2013-06-19

Ethicon Recalls Echelon 60mm Endoscopic Linear Cutter Reloads

Ethicon Endo-Surgery is voluntarily recalling Echelon 60mm endoscopic linear cutter reloads worldwide due to potential reload damage that could cause incomplete staple line formation.

What this means for you

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 is classified as FDA Class II, and the hazard involves a risk of harm (incomplete staple line formation) in a medical device where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Ethicon Endo-Surgery Inc is initiating a voluntary worldwide recall of ECHELON 60mm Endoscopic Linear Cutter Reloads (ECR60T). The recall affects 57,540 units of the black reloads packaged in flexible blisters with Tyvek lids. These sterile, single-patient-use instruments are designed to simultaneously cut and staple tissue during endoscopic procedures.

The recall is being conducted due to the potential for incomplete staple line formation resulting from reload damage during the firing sequence. The affected lots have expiration dates ranging from May 15, 2013, to March 15, 2014. The products were distributed nationwide in the United States and in numerous countries including Canada, Belgium, India, Malaysia, Saudi Arabia, Brazil, Israel, Mexico, Singapore, Jordan, New Zealand, Taiwan, Chile, Korea, Puerto Rico, Turkey, Colombia, Kuwait, Qatar, United Arab Emirates, Egypt, Lebanon, and Russia.

Healthcare providers and facilities should stop using the affected reloads and contact Ethicon Endo-Surgery for further instructions. Consumers should not use these medical devices, as they are intended for professional medical use only.

The recalled product

Product
ECHELON 60mm Endoscopic Linear Cutter Reloads Black in Flexible Blister pack with Tyvek lid. The ECHELON and ECHELON FLEX families of Endoscopic Linear Cutters (articulating and straight) are sterile, single patient use instruments that simultaneously cut and staple tissue. Th
Manufacturer
Ethicon Endo-Surgery Inc
Category
Medical Device — Surgical Instruments
Hazard
Affected units
57,540

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)

  • J4C00J 6/15/2013
  • J4C87R 7/15/2013
  • J4CC1F 8/15/2013
  • J4CD2X 8/15/2013
  • J4CF3D 9/15/2013
  • J4CJ0E 9/15/2013
  • J4CJ78 9/15/2013
  • J4CK2P 9/15/2013
  • J4CM9X 10/15/2013
  • J4CR2H 10/15/2013
  • J4CT5H 11/15/2013
  • J4CU86 11/15/2013
  • J4CV1W 11/15/2013
  • J4CV5H 11/15/2013
  • K4C149 12/15/2013
  • K4C17W 12/15/2013
  • K4C33U 12/15/2013
  • K4C41C 12/15/2013
  • K4C600 1/15/2014
  • K4C64A 1/15/2014

Distribution

Distributed nationwide across the United States.

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Same manufacturer · Ethicon Endo-Surgery Inc

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