Class II — Microline Surgical, Inc.
| Recalling firm | MICROLINE SURGICAL, INC. |
|---|---|
| Registered facility | Microline Surgical, Inc (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| 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. |
| Quantity | 61,769 units |
| Distribution | Worldwide Distribution-US (Nationwide) and countries of: Australia, Brazil, Canada, Chile, China, Colombia, El Salvador, Hong Kong, India, Indonesia, Malaysia, Mexico, Panama, Peru, Argentina, South Korea, Sri Lanka, Taiwan, Thailand, Uruguay & Vietnam. |
| Initiated | 2017-07-13 |
| Classified | 2018-02-02 |
| Terminated | 2020-02-06 |
| Recall number | Z-0507-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Microline Surgical, Inc. (Z-0507-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/78754/
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