Covidien Endo GIA Ultra Universal 12 mm Short Stapler Handle Ref:… — Class II medical device recall Z-0819-2016
Terminated recall by Medtronic, reported 2016-02-24, distributed nationwide. Staplers fail to fire or partially fire and reports of the instrument articulating lever disengaging during us
| Recall number | Z-0819-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic, North Haven, CT, United States |
| Recall initiated | 2015-12-02 |
| Classified | 2016-02-18 |
| Reported by FDA | 2016-02-24 |
| Terminated | 2019-07-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BG, BH, BO, BR, CA, CH, CL, CO, CR, CY, CZ, DE, DK, DZ, EC, EE, EG, ES, FI, FR, GB, GR, GT, HN, HR, HU, IE, IL, IR, IS, IT, JO, JP, KE, KW, LB, LT, LU, LV, MA, MX, NG, NI, NL, NO, PA, PE, PL, PT, PY, RO, RS, RU, SA, SE, SI, SK, SV, TN, TR, UA, UY, VE, ZA |
| Quantity | 364,768 units |
Product
Covidien Endo GIA Ultra Universal 12 mm Short Stapler Handle Ref: EGIAUSHORT Product Usage: The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures. The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers when used with the Endo GIA curved tip single use reloads can be used to blunt dissect or separate target tissue from other tissue.
Reason for recall
Staplers fail to fire or partially fire and reports of the instrument articulating lever disengaging during use
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-0819-2016. 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.