Class II — Microline Surgical
| Recalling firm | MICROLINE SURGICAL, INC. |
|---|---|
| Registered facility | Microline Surgical, Inc (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Grasper jaw may break when force is applied to the jaw |
| 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. |
| Quantity | 540 units |
| Distribution | Worldwide Distribution - US including the states of TX, IL, TN and NY, and the country of Chile. |
| Initiated | 2014-04-14 |
| Classified | 2014-05-20 |
| Terminated | 2015-09-02 |
| Recall number | Z-1635-2014 |
| 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 (Z-1635-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/68012/
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