Straight Intraluminal Staplers — Class I medical device recall Z-1278-2019
Completed recall by Ethicon Endo-Surgery Inc, reported 2019-05-22, distributed nationwide. The staplers may have an insufficient firing stroke to break the washer and completely form staples.
| Recall number | Z-1278-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ethicon Endo-Surgery Inc, Blue Ash, OH, United States |
| Recall initiated | 2019-04-11 |
| Classified | 2019-05-15 |
| Reported by FDA | 2019-05-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AW, BD, BE, BH, BO, BR, CA, CL, CN, CR, EC, EG, GT, HN, ID, IL, IN, JM, JO, JP, KR, KW, LB, LK, MX, MY, NI, NP, OM, PA, PE, PH, PK, PY, QA, SA, SG, SV, TH, TW, UY, VN |
| Quantity | 434,614 total |
| Reason classes | device malfunction |
| Model numbers | DH33A |
Product
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.
Reason for recall
The staplers may have an insufficient firing stroke to break the washer and completely form staples.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1278-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.