CLASS II Device recall · Reported 9 Jul 2014 · FDA Enforcement Report

ReNew Laproscopic Fenestrated Grasper Forceps Tips (Reusable) recalled

Microline Surgical is recalling ReNew Laproscopic Fenestrated Grasper Forceps Tips (Reusable), distributed in 10 states. The recall was initiated on 12 May 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Numbers: Lot Number 00115282 Lot Number 00115283 Lot Number 00115284 Lot Number 00115340 Lot Number 00115341 Lot Number 00115501 Lot Number 00115502 Lot Number 00115865 Lot Number 00116277 Lot Number 00116278

Quantity recalled6290 units

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-1987-2014
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 (Reusable) Ref 3222

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.

California Hawaii Idaho Massachusetts Michigan Mississippi Pennsylvania Tennessee Texas Utah

Questions about this recall

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: Lot Number 00115282 Lot Number 00115283 Lot Number 00115284 Lot Number 00115340 Lot Number 00115341 Lot Number 00115501 Lot Number 00115502 Lot Number 00115865 Lot Number 00116277 Lot Number 00116278

Where was it sold?

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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 68495

Reported	Class	Recall	Company	Reason	Where
9 Jul 2014	CLASS II	ReNew Laproscopic Fenestrated Grasper Forceps Tips recalled	Microline Surgical	Device Malfunction	10 states

More recalls from Microline Surgical

All 8

Reported	Class	Recall	Company	Reason	Where
18 Dec 2024Device	CLASS II	Microscissor Tip (Disposable) recalled by Microline Surgical	Microline Surgical	Device Malfunction	Nationwide
12 Jun 2019Device	CLASS II	TLS2 Thermal Ligating Shears recalled by Microline Surgical	Microline Surgical	Device Malfunction	ND, NY
16 May 2018Device	CLASS II	ReNew Dolphin Nose Disposable Dissector Tip recalled	Microline Surgical	Sterility	5 states
16 May 2018Device	CLASS II	ReNew Endocut Scissor Disposable Tip recalled by Microline Surgical	Microline Surgical	Sterility	5 states
14 Feb 2018Device	CLASS II	The ReNew Reusable Grasper and Dissector Tips are to be recalled	Microline Surgical	Sterility	Nationwide

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