Ethicon Endo-Surgery Inc: Curved Intraluminal Staplers, 29 mm diameter, Model CDH29A 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 anvil shaft in a location remote from the main body of the instrument to improve access and visibility.

Recall number

Z-1269-2019

Recalling firm

Ethicon Endo-Surgery Inc

Product

Curved Intraluminal Staplers, 29 mm diameter, Model CDH29A 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 anvil shaft in a location remote from the main body of the instrument to improve access and visibility.

Status

Completed

Initiated

2019-04-11

Posted

not on file

Terminated

not on file

Reason

The staplers may have an insufficient firing stroke to break the washer and completely form staples.

Root cause

Under Investigation by firm

Action

The firm, ETHICON, sent an "URGENT: MEDICAL DEVICE RECALL (REMOVAL)" letters to US customers beginning 4/11/19. The letters described the product, problem and actions to be taken. The customers were instructed to the following: 1. Examine your inventory immediately to determine if you have product subject to this recall (removal) on hand and quarantine such product(s). 2. Remove the product subject to this voluntary recall (removal). 3. It is not necessary to contact your end customers regarding this action. Ethicon will directly communicate with customers about the above listed product subject to this recall (removal). 4. Complete the Business Reply Form (BRF) (Attachment 2) confirming receipt of this notice and fax or email it to Stericycle at 866-873-0312 or ethicon5011@stericycle.com within three (3) business days. Please return the BRF even if you do not have product subject to this recall (removal). 5. Keep this notice visibly posted for awareness until all product subject to this recall (removal) has been returned to Stericycle. While processing your returns, please maintain a copy of this notice with the product subject to this recall (removal) and keep a copy for your records. 6. Distributors are required to return unused impacted Intraluminal Stapler (ILS) subject to this recall (removal) that are in their inventory immediately. Only Intraluminal Stapler (ILS) subject to this recall (removal) returned by June 30, 2019 will be eligible for credit reimbursement. Any product subject to this recall (removal) returned after the date specified will not be eligible for credit reimbursement. 7. To return product subject to this recall (removal), photocopy the completed BRF, place it in the box with the product, and affix the pre-paid authorized shipping label included with the recall notification letter. Ethicon will pay for the shipping charges only if the authorized label is used. Extra shipping labels may be obtained by calling Stericycle at 1-888-671-88

Quantity

434,614 total

Distribution

Worldwide Distribution: US (nationwide) and countries of: Argentina, Aruba, Bahrain, Bangladesh, Belgium, Bolivia, Brazil, Canada, Chile, China, Columbia, Costa Rica, Ecuador, Egypt, El Salvador, Guatemala, Honduras, India, Indonesia, Israel, Jamaica, Japan, Jordan, Korea, Kuwait, Lebanon, Malaysia, Maldives, Mexico, Nepal. Nicaragua, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Qatar, Saudi Arabia, Singapore, Sri Lanka, Taiwan, Thailand, UAE, Uruguay, Vietnam, and Yemen.

Lot, serial or model codes

All Lots within EXPIRATION Date Range: December 2022 March 2024

510(k) numbers

["K983536"]

PMA numbers

not on file

Product code

GDW

Firm FEI

1527736

Firm city

Blue Ash

Firm state

OH

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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