The ReNew Reusable Grasper and Dissector Tips are to be used with the… — Class II medical device recall Z-0507-2018
Terminated recall by Microline Surgical, Inc., reported 2018-02-14, distributed nationwide. The heat-shrink insulation tube may split during autoclave sterilization/re-sterilization. If a split occurs,
| Recall number | Z-0507-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Microline Surgical, Inc., Beverly, MA, United States |
| Recall initiated | 2017-07-13 |
| Classified | 2018-02-02 |
| Reported by FDA | 2018-02-14 |
| Terminated | 2020-02-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, BR, CA, CL, CN, CO, HK, ID, IN, KR, LK, MX, MY, PA, PE, SV, TH, TW, UY, VN |
| Quantity | 61,769 units |
| UPC / GTIN / UDI-DI | 00811099011644, 00811099011651, 00811099011668, 00811099011675, 00811099011682, 00811099011699, 00811099011705, 00811099011712, 00811099011729, 00811099011736, 00811099011743, 00811099011767, 00811099011774, 00811099011781, 00811099011804, 00811099011811, 00811099011828, 00811099011835, 00811099011842, 00811099011859 |
Product
The ReNew Reusable Grasper and Dissector Tips are to be used with the ReNew Laparoscopic Handpieces and they are indicated for cutting, grasping, dissecting, and coagulation of tissue in endoscopic and laparoscopic surgical procedures.
Reason for recall
The heat-shrink insulation tube may split during autoclave sterilization/re-sterilization. If a split occurs, the heat-shrink could fall off during a surgical procedure and if cautery is needed, there is a potential for burn due to insulation failure.
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-0507-2018. 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.