CLASS II Device recall · Reported 9 Jul 2014 · FDA Enforcement Report
ReNew Laproscopic Fenestrated Grasper Forceps Tips recalled
Microline Surgical is recalling Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips, distributed in 10 states. The recall was initiated on 12 May 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1986-2014
- FDA event ID
- 68495
- Recalling firm
- Microline Surgical, Beverly, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 May 2014
- FDA classified
- 2 Jul 2014
- Reported
- 9 Jul 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Surgical Instruments
Timeline
| 12 May 2014 | Recall initiated by company | |
| 2 Jul 2014 | Classified by FDA | +51 days |
| 9 Jul 2014 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for the Fenestrated Grasper Tip jaw to break when force is applied to the jaw
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips Ref 3221
Where it was distributed
Worldwide Distribution-USA including the states of CA, HI, ID, MA, MI, MS, PA, TN, UT, and TX. and the countries of Belgium, France, Ireland, Germany, Indonesia, Korea, Norway, Saudi Arabia, Switzerland, Turkey, and UK.
CaliforniaHawaiiIdahoMassachusettsMichiganMississippiPennsylvaniaTennesseeTexasUtah
Questions about this recall
Is ReNew Laproscopic Fenestrated Grasper Forceps Tips recalled?
Yes. Microline Surgical recalled ReNew Laproscopic Fenestrated Grasper Forceps Tips on 12 May 2014. The recall is Class II and its status is Terminated. Recall number Z-1986-2014.
Why was it recalled?
Potential for the Fenestrated Grasper Tip jaw to break when force is applied to the jaw
Which lots are affected?
Lot Numbers: 00115342
Where was it sold?
Worldwide Distribution-USA including the states of CA, HI, ID, MA, MI, MS, PA, TN, UT, and TX. and the countries of Belgium, France, Ireland, Germany, Indonesia, Korea, Norway, Saudi Arabia, Switzerland, Turkey, and UK.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Microline Surgical
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Microscissor Tip (Disposable) recalled by Microline Surgical | Microline Surgical | Device Malfunction | Nationwide |
| Device | CLASS II | TLS2 Thermal Ligating Shears recalled by Microline Surgical | Microline Surgical | Device Malfunction | ND, NY |
| Device | CLASS II | ReNew Dolphin Nose Disposable Dissector Tip recalled | Microline Surgical | Sterility | 5 states |
| Device | CLASS II | ReNew Endocut Scissor Disposable Tip recalled by Microline Surgical | Microline Surgical | Sterility | 5 states |
| Device | CLASS II | The ReNew Reusable Grasper and Dissector Tips are to be recalled | Microline Surgical | Sterility | Nationwide |
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