The Recall Desk
SevereFDA (Devices)·Z-0202-2020·Announced 2019-11-06

Ethicon Echelon Flex Powered Plus Endopath 60mm Stapler Recall

Ethicon is recalling 5,040 Echelon Flex Powered Plus Endopath 60mm Staplers due to out-of-specification anvil components that may compromise staple line integrity.

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 source text explicitly lists 'death' as a potential risk resulting from the defect, which meets the rubric criteria for a score of 4 (Severe) due to significant injury or death reports/risks, and the agency classification is Class I.

Plain-English summary

Ethicon Endo-Surgery Inc is recalling 5,040 units of the ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 440mm shaft (Product Code PLEE60A). The recall covers specific lots including T93Z1G, T93Y4M, T94045, T94117, T93X17, T94087, T93Z2X, T9405L, T94253, T93X95, T93Z75, T93Z2W, and T9413Z.

The recall is issued because the staplers may contain an out-of-specification anvil component within the jaw of the device. This condition may lead to malformed staples, which can compromise staple line integrity. If the staple line is compromised, there is a potential risk of prolonged surgery, postoperative anastomotic leak, hemorrhage, hemorrhagic shock, additional surgical intervention, or death.

The affected products were distributed worldwide, including in the United States, Belgium, Brazil, Canada, Chile, Colombia, Japan, Kuwait, Saudi Arabia, and Singapore. Healthcare providers and facilities should check their inventory for the affected product codes and lot numbers and stop using these devices.

The recalled product

Product
ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 440mm shaft, Product Code PLEE60A
Manufacturer
Ethicon Endo-Surgery Inc
Category
Medical Device — Surgical Stapler
Hazard
Affected units
5,040

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 (13)

  • Lot: T93Z1G
  • T93Y4M
  • T94045
  • T94117
  • T93X17
  • T94087
  • T93Z2X
  • T9405L
  • T94253
  • T93X95
  • T93Z75
  • T93Z2W
  • T9413Z

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 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 4 products in this recall →

Related recalls

Same manufacturer · Ethicon Endo-Surgery Inc

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Same hazard · malformed staples

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