The Recall Desk
Agency classClass IOur severity:CriticalFDA (Devices)·Z-1273-2019·Announced 2019-05-22

Ethicon Endo-Surgery Recalls Endoscopic Curved Intraluminal Staplers

Ethicon Endo-Surgery is recalling 434,614 endoscopic curved intraluminal staplers because they may have an insufficient firing stroke to break the washer and completely form staples.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The source text explicitly states the agency classification is 'Class I'. According to the rubric, if the agency's own classification is FDA Class I, the score must be 5 (Critical) regardless of other factors.

Plain-English summary

Ethicon Endo-Surgery Inc is recalling 434,614 units of the Endoscopic Curved Intraluminal Stapler, 29 mm diameter, Model ECS29A. The recall covers all lots with expiration dates ranging from February 2023 to March 2024. These anastomotic staplers are designed to permit tissue attachment to the anvil shaft in a location remote from the main body of the instrument to improve access and visibility.

The recall was initiated because the staplers may have an insufficient firing stroke to break the washer and completely form staples. This defect could compromise the integrity of the surgical anastomosis. The agency has classified this recall as Class I, which indicates a reasonable probability that the use of, or exposure to, the violative product will cause serious adverse health consequences or death.

The affected products were distributed worldwide, including nationwide in the United States and in numerous international markets such as Canada, Mexico, Brazil, China, India, Japan, and the United Kingdom. Healthcare providers and facilities that have purchased or received these specific staplers should stop using them immediately and contact Ethicon Endo-Surgery for instructions on how to return the devices.

The recalled product

Product
Endoscopic Curved Intraluminal Stapler, 29 mm diameter, Model ECS29A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue…
Manufacturer
Ethicon Endo-Surgery Inc
Category
Medical Device — Surgical Instruments
Hazard
Affected units
434,614

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 (1)

  • All Lots within EXPIRATION Date Range: February 2023 March 2024

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 12 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 12 products in this recall →

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