Class I — Ethicon Endo-Surgery Inc
| Recalling firm | ETHICON ENDO-SURGERY, INC. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class I |
| Status | Completed |
| Reason | The staplers may have an insufficient firing stroke to break the washer and completely form staples. |
| Product | 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. |
| 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, Sau… |
| Initiated | 2019-04-11 |
| Classified | 2019-05-15 |
| Recall number | Z-1271-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Ethicon Endo-Surgery Inc (Z-1271-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/82539/
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