Covidien Endo Grasp Auto Suture Grasper 5mm REF: 173030 The Covidien… — Class II medical device recall Z-1212-2019
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-1212-2019 |
|---|---|
| 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 | 240 units |
| Reason classes | labeling |
| Lot numbers | P8D1335PRX, P8D1336PRX, P8D1605PRX |
| Model numbers | 173030 |
Product
Covidien Endo Grasp Auto Suture Grasper 5mm REF: 173030 The Covidien Endo Grasp" Auto Suture" grasper 5 mm instrument has applications in a variety of gynecologic, general, urologic, thoracic and endoscopic procedures for temporary grasping/clamping of tissue and small tubular structures.
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-1212-2019. 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.