Microline Renew Fenestrated Control Tip Grasper — Class II medical device recall Z-1635-2014
Terminated recall by Microline Surgical, reported 2014-05-28, distributed in IL, NY, TN, TX. Grasper jaw may break when force is applied to the jaw
| Recall number | Z-1635-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Microline Surgical, Beverly, MA, United States |
| Recall initiated | 2014-04-14 |
| Classified | 2014-05-20 |
| Reported by FDA | 2014-05-28 |
| Terminated | 2015-09-02 |
| Distributed | IL, NY, TN, TX |
| Countries outside the US | CL |
| Quantity | 540 units |
| Reason classes | device malfunction |
| Lot numbers | 00115866, 00116169 |
Product
Microline Renew Fenestrated Control Tip Grasper, Single Patient Use, Product Number: 3222 The ReNew Fenestrated Grasper Forceps Tips are intended to cut, grasp, and dissect various abdominal tissue for use in endoscopic, including laproscopic surgical procedures where instruments are introduced onto the body through a cannula.
Reason for recall
Grasper jaw may break when force is applied to the jaw
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-1635-2014. 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.