FDA Device recall Z-1277-2019
Straight Intraluminal Staplers, 29 mm diameter, Model SDH29A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers…
- FDA Device
- Class I
- completed
- Published 2019-05-22
On 2019-05-22 the FDA classified a Class I recall of Straight Intraluminal Staplers, 29 mm diameter, Model SDH29A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers… by Ethicon Endo Surgery, citing the staplers may have an insufficient firing stroke to break the washer and completely form staples.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1277-2019 |
| Classification | Class I |
| Status | completed |
| Initiated | 2019-04-11 |
| Published | 2019-05-22 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ethicon Endo Surgery |
| Distribution | US |
Product
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.
Reason
The staplers may have an insufficient firing stroke to break the washer and completely form staples.
Identifiers
| code_info | All Lots within EXPIRATION Date Range: February 2023 March 2024 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1277-2019%22
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