The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1270-2019·Announced 2019-05-22

Ethicon Curved Intraluminal Staplers Recalled for Insufficient Firing Stroke

Ethicon Endo-Surgery is recalling 434,614 Curved Intraluminal Staplers (Model CDH33A) because they may have an insufficient firing stroke to break the washer and 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 recall involves a structural defect in a medical device used for surgical anastomosis that could lead to serious injury or death if the staples do not form completely, meeting the criteria for a Severe (Score 4) classification.

Plain-English summary

Ethicon Endo-Surgery Inc is recalling 434,614 units of Curved Intraluminal Staplers, 33 mm diameter, Model CDH33A. The recall covers all lots with expiration dates between December 2022 and March 2024. These devices 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 compromise the integrity of the surgical anastomosis.

The affected products were distributed worldwide, including nationwide in the United States and in numerous other countries such as Canada, Japan, and the United Kingdom. Healthcare providers and facilities should stop using these devices and contact Ethicon Endo-Surgery for further instructions.

The recalled product

Product
Curved Intraluminal Staplers, 33 mm diameter, Model CDH33A 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 attachment to the…
Manufacturer
Ethicon Endo-Surgery Inc
Category
Medical Device — Surgical Staplers
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: December 2022 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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