Ethicon Straight Intraluminal Staplers: Risk of Incomplete Staple Formation
Ethicon recalls Straight Intraluminal Staplers (Model SDH25A) due to potential incomplete staple formation. Affected units were sold between February 2023 and March 2024. Consumers should contact Ethicon for details.
Lower-risk recall
The staplers may have an insufficient firing stroke to break the washer and completely form staples.
Contact the company
What happened, in plain English
Ethicon recalls Straight Intraluminal Staplers (Model SDH25A) because they may not form staples properly. This could lead to tissue damage during medical procedures. Affected units were sold between February 2023 and March 2024. Read more at govinfonow.com/recall/68349-ethicon-straight-intraluminal-staplers-risk-of-incomplete-staple-formation.
Source Summary by GovInfoNow · govinfonow.com/recall/68349-ethicon-straight-intraluminal-staplers-risk-of-incomplete-staple-formation · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1276-2019
Cite this page
“Ethicon Straight Intraluminal Staplers: Risk of Incomplete Staple Formation.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/68349-ethicon-straight-intraluminal-staplers-risk-of-incomplete-staple-formation. Based on FDA recall #Z-1276-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1276-2019%22&limit=1).
Why it’s dangerous
The staplers may not form staples completely due to an insufficient firing stroke. This could cause tissue damage or improper closure during surgery. The issue affects the device's ability to create secure tissue attachments.
Who’s affected
Medical professionals using the staplers for surgical procedures are most at risk. Patients undergoing surgery with these staplers may experience complications.
How to tell if you have this one
Check for the model number SDH25A on the stapler. Affected units were sold between February 2023 and March 2024.
- Brand
Ethicon- Category
Medical device
All 12 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class I- Status
Completed- 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.
| Recall number | Product, codes & lots |
|---|---|
| Z-1267-2019 | Curved Intraluminal Staplers, 21 mm diameter, Model CDH21A 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.; All Lots within EXPIRATION Date Range: December 2022 March 2024 |
| Z-1268-2019 | Curved Intraluminal Staplers, 25 mm diameter, Model CDH25A 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.; All Lots within EXPIRATION Date Range: December 2022 March 2024 |
| Z-1269-2019 | 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.; All Lots within EXPIRATION Date Range: December 2022 March 2024 |
| Z-1270-2019 | 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 anvil shaft in a location remote from the main body of the instrument to improve access and visibility.; All Lots within EXPIRATION Date Range: December 2022 March 2024 |
| Z-1271-2019 | Endoscopic Curved Intraluminal Stapler, 21 mm diameter, Model ECS21A 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.; All Lots within EXPIRATION Date Range: February 2023 March 2024 |
| Z-1272-2019 | 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 attachment to the anvil shaft in a location remote from the main body of the instrument to improve access and visibility.; All Lots within EXPIRATION Date Range: February 2023 March 2024 |
| Z-1273-2019 | 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 attachment to the anvil shaft in a location remote from the main body of the instrument to improve access and visibility.; All Lots within EXPIRATION Date Range: February 2023 March 2024 |
| Z-1274-2019 | Endoscopic Curved Intraluminal Stapler, 33 mm diameter, Model ECS33A 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.; All Lots within EXPIRATION Date Range: February 2023 March 2024 |
| Z-1275-2019 | Straight Intraluminal Staplers, 21 mm diameter, Model SDH21A 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.; All Lots within EXPIRATION Date Range: February 2023 March 2024 |
| Z-1276-2019 | Straight Intraluminal Staplers, 25 mm diameter, Model SDH25A 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.; All Lots within EXPIRATION Date Range: February 2023 March 2024 |
| Z-1277-2019 | Straight Intraluminal Staplers, 29 mm diameter, Model SDH29A 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.; All Lots within EXPIRATION Date Range: February 2023 March 2024 |
| Z-1278-2019 | Straight Intraluminal Staplers, 33 mm diameter, Model SDH33A 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.; All Lots within EXPIRATION Date Range: February 2023 March 2024 |
What to do — step by step
Check Product Details
Look for the model number SDH25A on the stapler to confirm if it is affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 41 days after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1276-2019 (April 11, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1276-2019 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.