The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1272-2019·Announced 2019-05-22

Ethicon Endo-Surgery Recalls Endoscopic Curved Intraluminal Staplers

Ethicon Endo-Surgery is recalling 434,614 Endoscopic Curved Intraluminal Staplers (Model ECS25A) 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "The staplers may have an insufficient firing stroke to break the washer and completely form staples."

Plain-English summary

Ethicon Endo-Surgery Inc is recalling 434,614 units of the Endoscopic Curved Intraluminal Stapler, 25 mm diameter, Model ECS25A. The recall covers all lots with expiration dates ranging from February 2023 to March 2024. These instruments are anastomotic staplers used 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 is being issued because the staplers may have an insufficient firing stroke to break the washer and completely form staples. This defect could potentially affect the performance of the device during use.

The affected products were distributed worldwide, including nationwide in the United States and in numerous other countries such as Argentina, Canada, China, India, Japan, and Mexico. Healthcare providers and facilities that have purchased or received these specific staplers should stop using them and contact Ethicon Endo-Surgery Inc for further instructions on the recall process.

The recalled product

Product
Endoscopic Curved Intraluminal Stapler, 25 mm diameter, Model ECS25A 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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