CLASS II Device recall · Reported 16 May 2018 · FDA Enforcement Report

ReNew Dolphin Nose Disposable Dissector Tip recalled

Microline Surgical is recalling ReNew Dolphin Nose Disposable Dissector Tip, distributed in Florida, Massachusetts, Michigan, Ohio, Tennessee. The recall was initiated on 1 Nov 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Numbers: 70208, 70209, 70210 UDI: 00811099011989

Quantity recalled12 box of 10 tips each

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-1740-2018
FDA event ID: 79435
Recalling firm: Microline Surgical, Beverly, MA
Classification: Class II
Status: Terminated
Recall initiated: 1 Nov 2017
FDA classified: 8 May 2018
Reported: 16 May 2018
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Sterility
Device type: Surgical Instruments

Timeline

1 Nov 2017	Recall initiated by company
8 May 2018	Classified by FDA	+188 days
16 May 2018	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

Certain lots of disposable laparoscopic instrument tips may potentially have a compromised sterile barrier.

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

ReNew Dolphin Nose Disposable Dissector Tip, Catalog Number: 3312, UDI: 00811099011989 The ReNew single patient use disposable tips are to be used with the ReNew Laparoscopic Hand Pieces and they are indicated for cutting, grasping, dissecting and coagulation of tissue in endoscopic and laparoscopic surgical procedures.

Where it was distributed

Distributed in the following U.S. states: FL, MA, MI, OH, OK TN, and Netherlands.

Florida Massachusetts Michigan Ohio Tennessee

Questions about this recall

Why was it recalled?

Certain lots of disposable laparoscopic instrument tips may potentially have a compromised sterile barrier.

Which lots are affected?

Lot Numbers: 70208, 70209, 70210 UDI: 00811099011989

Where was it sold?

Distributed in the following U.S. states: FL, MA, MI, OH, OK TN, and Netherlands.

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 79435

This product is part of a recall event; the main page for the event is ReNew Endocut Scissor Disposable Tip recalled by Microline Surgical.

Reported	Class	Recall	Company	Reason	Where
16 May 2018	CLASS II	ReNew Endocut Scissor Disposable Tip recalled by Microline Surgical	Microline Surgical	Sterility	5 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 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
9 Jul 2014Device	CLASS II	ReNew Laproscopic Fenestrated Grasper Forceps Tips recalled	Microline Surgical	Device Malfunction	10 states

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