Covidien Endo Clinch II Auto Suture Grasper — Class II medical device recall Z-1211-2019
Terminated recall by COVIDIEN LLC, reported 2019-05-01, distributed nationwide. Sterilization method used was not consistent with the labeling and the approved sterilization method
| Recall number | Z-1211-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | COVIDIEN LLC, Mansfield, MA, United States |
| Recall initiated | 2019-03-13 |
| Classified | 2019-04-23 |
| Reported by FDA | 2019-05-01 |
| Terminated | 2020-04-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CH, CL, CR, ES, GT, JP, MX, PA, SK, TR |
| Quantity | 7,248 units |
| Reason classes | labeling |
| Lot numbers | P8D1333PRX, P8D1334PRX, P8D1614PRX, P8D1615PRX, P8D1616PRX, P8E1143PRX, P8E1189PRX, P8E1269PRX, P8E1271PRX, P8E1272PRX, P8F0008PRX, P8F1238PRX, P8F1239PRX, P8F1307PRX, P8F1448PRX, P8F1452PRX, P8F1480PRX, P8F1545PRX |
| Model numbers | 174317 |
Product
Covidien Endo Clinch II Auto Suture Grasper, 5mm REF: 174317 The Covidien Endo Clinch" II Auto Suture" grasper 5mm has a 5 mm diameter, rotating, insulated shaft approximately 31 cm in length and is designed for introduction and use through the appropriately sized Covidien" trocar sleeve or larger sized sleeve with the use of a converter. The atraumatic jaws are clamped and locked onto tissue structures by closing the handles
Reason for recall
Sterilization method used was not consistent with the labeling and the approved sterilization method
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-1211-2019. 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.