CLASS II Device recall · Reported 14 Feb 2018 · FDA Enforcement Report

The ReNew Reusable Grasper and Dissector Tips are to be recalled

Microline Surgical is recalling The ReNew Reusable Grasper and Dissector Tips are to be used with the ReNew Laparoscopic, distributed nationwide in the US. The recall was initiated on 13 Jul 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lots of product codes: 3201,3221,3231,3241,3251,3261,3271,3281,3291,3301,3311,3321,3331,3341, 3351,3361,3371,3381,3401,3411,3421,3431 UDI's for listed lots of product codes: 3201-UDI 00811099011644, 3221-UDI 00811099011651, 3231-UDI 00811099011668, 3241-UDI 00811099011675, 3251-UDI 00811099011682, 3261-UDI 00811099011699, 3271-UDI 00811099011705, 3281-UDI 00811099011712, 3291-UDI 00811099011729, 3301-UDI 00811099011859, 3311-UDI 00811099011736, 3321-UDI 00811099011743, 3331-UDI 00811099011767, 3341-UDI 00811099011774, 3351-UDI 00811099011781, 3371-UDI 00811099011804, 3381-UDI 00811099011811, 3401-UDI 00811099011828, 3411-UDI 00811099011835, 3421-UDI 00811099011842, 3431-UDI 00811099011644

Quantity recalled61,769 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-0507-2018
FDA event ID: 78754
Recalling firm: Microline Surgical, Beverly, MA
Classification: Class II
Status: Terminated
Recall initiated: 13 Jul 2017
FDA classified: 2 Feb 2018
Reported: 14 Feb 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Surgical Instruments

Timeline

13 Jul 2017	Recall initiated by company
2 Feb 2018	Classified by FDA	+204 days
14 Feb 2018	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The heat-shrink insulation tube may split during autoclave sterilization/re-sterilization. If a split occurs, the heat-shrink could fall off during a surgical procedure and if cautery is needed, there is a potential for burn due to insulation failure.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

The ReNew Reusable Grasper and Dissector Tips are to be used with the ReNew Laparoscopic Handpieces and they are indicated for cutting, grasping, dissecting, and coagulation of tissue in endoscopic and laparoscopic surgical procedures.

Where it was distributed

Worldwide Distribution-US (Nationwide) and countries of: Australia, Brazil, Canada, Chile, China, Colombia, El Salvador, Hong Kong, India, Indonesia, Malaysia, Mexico, Panama, Peru, Argentina, South Korea, Sri Lanka, Taiwan, Thailand, Uruguay & Vietnam.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

All lots of product codes: 3201,3221,3231,3241,3251,3261,3271,3281,3291,3301,3311,3321,3331,3341, 3351,3361,3371,3381,3401,3411,3421,3431 UDI's for listed lots of product codes: 3201-UDI 00811099011644, 3221-UDI 00811099011651, 3231-UDI 00811099011668, 3241-UDI 00811099011675, 3251-UDI 00811099011682, 3261-UDI 00811099011699, 3271-UDI 00811099011705, 3281-UDI 00811099011712, 3291-UDI 00811099011729, 3301-UDI 00811099011859, 3311-UDI 00811099011736, 3321-UDI 00811099011743, 3331-UDI 00811099011767, 3341-UDI 00811099011774, 3351-UDI 00811099011781, 3371-UDI 00811099011804, 3381-UDI 00811099011811, 3401-UDI 00811099011828, 3411-UDI 00811099011835, 3421-UDI 00811099011842, 3431-UDI 00811099011644

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.

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
9 Jul 2014Device	CLASS II	ReNew Laproscopic Fenestrated Grasper Forceps Tips recalled	Microline Surgical	Device Malfunction	10 states

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