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 | Certain lots of disposable laparoscopic instrument tips may potentially have a compromised sterile barrier. |
| Product | ReNew Endocut Scissor Disposable Tip, Catalog Number: 3142, UDI: 00811099012115 The ReNew single patient use disposable tips are to be used with the ReNew Laparoscopic Hand Pieces and they are indicated for cutting, grasping, dissecting and coagulation of tissue in endoscopic and laparoscopic surgical procedures. |
| Quantity | 4 boxes of 10 tips each |
| Distribution | Distributed in the following U.S. states: FL, MA, MI, OH, OK TN, and Netherlands. |
| Initiated | 2017-11-01 |
| Classified | 2018-05-08 |
| Terminated | 2019-09-17 |
| Recall number | Z-1741-2018 |
| 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-1741-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79435/
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