FDA Device recall Z-0507-2018
The ReNew Reusable Grasper and Dissector Tips are to be used with the ReNew Laparoscopic Handpieces and they are indicated for cutting, gra…
- FDA Device
- Class II
- terminated
- Published 2018-02-14
On 2018-02-14 the FDA classified a Class II recall of The ReNew Reusable Grasper and Dissector Tips are to be used with the ReNew Laparoscopic Handpieces and they are indicated for cutting, gra… by Microline Surgical, citing 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 cau….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0507-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-07-13 |
| Published | 2018-02-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Microline Surgical |
| Distribution | US |
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
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.
Identifiers
| code_info | All lots of product codes: 3201,3221,3231,3241,3251,3261,3271,3281,3291,3301,3311,3321,3331,3341, 3351,3361,3371,3381,3…All lots of product codes: 3201,3221,3231,3241,3251,3261,3271,3281,3291,3301,3311,3321,3331,3341, 3351,3361,3371,3381,3401,3411,3421,3431 UDI's for listed lots of product codes: 3201-UDI 00811099011644, 3221-UDI 00811099011651, 3231-UDI 00811099011668, 3241-UDI 00811099011675, 3251-UDI 00811099011682, 3261-UDI 00811099011699, 3271-UDI 00811099011705, 3281-UDI 00811099011712, 3291-UDI 00811099011729, 3301-UDI 00811099011859, 3311-UDI 00811099011736, 3321-UDI 00811099011743, 3331-UDI 00811099011767, 3341-UDI 00811099011774, 3351-UDI 00811099011781, 3371-UDI 00811099011804, 3381-UDI 00811099011811, 3401-UDI 00811099011828, 3411-UDI 00811099011835, 3421-UDI 00811099011842, 3431-UDI 00811099011644 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0507-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.