CLASS II Device recall · Reported 28 May 2014 · FDA Enforcement Report
Microline Renew Fenestrated Control Tip Grasper recalled
Microline Surgical is recalling Microline Renew Fenestrated Control Tip Grasper, Single Patient Use, Product Number: 3222, distributed in Illinois, New York, Tennessee, Texas. The recall was initiated on 14 Apr 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-1635-2014
- FDA event ID
- 68012
- Recalling firm
- Microline Surgical, Beverly, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Apr 2014
- FDA classified
- 20 May 2014
- Reported
- 28 May 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Heart & Vascular Devices
Timeline
| 14 Apr 2014 | Recall initiated by company | |
| 20 May 2014 | Classified by FDA | +36 days |
| 28 May 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Grasper jaw may 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 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.
Where it was distributed
Worldwide Distribution - US including the states of TX, IL, TN and NY, and the country of Chile.
Questions about this recall
Is Microline Renew Fenestrated Control Tip Grasper, Single Patient Use, Product Number: 3222 recalled?
Yes. Microline Surgical recalled Microline Renew Fenestrated Control Tip Grasper, Single Patient Use, Product Number: 3222 on 14 Apr 2014. The recall is Class II and its status is Terminated. Recall number Z-1635-2014.
Why was it recalled?
Grasper jaw may break when force is applied to the jaw
Which lots are affected?
Lot Numbers: 00116169 and 00115866
Where was it sold?
Worldwide Distribution - US including the states of TX, IL, TN and NY, and the country of Chile.
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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