Agency classClass IIOur severity:High FDA (Devices)·Z-1741-2018·Announced 2018-05-16

Microline Surgical Recalls ReNew Endocut Scissor Tips Due to Sterility Concerns

Microline Surgical is recalling specific lots of ReNew Endocut Scissor Disposable Tips because the sterile barrier may be compromised.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a compromised sterile barrier, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Microline Surgical, Inc. is recalling certain lots of ReNew Endocut Scissor Disposable Tips, Catalog Number 3142. The recall involves 4 boxes of 10 tips each, identified by Lot Number 70211 and UDI 00811099012115. These single-patient-use disposable tips are designed for use with ReNew Laparoscopic Hand Pieces for cutting, grasping, dissecting, and coagulation of tissue in endoscopic and laparoscopic surgical procedures.

The recall was initiated because the disposable tips may potentially have a compromised sterile barrier. This defect could affect the sterility of the instruments during surgical use.

The affected products were distributed in the U.S. states of Florida, Massachusetts, Michigan, Ohio, Oklahoma, and Tennessee, as well as in the Netherlands. Healthcare facilities and consumers who have these specific lots should stop using the product and contact Microline Surgical for further instructions.

The recalled product

Product: ReNew Endocut Scissor Disposable Tip, Catalog Number: 3142, UDI: 00811099012115 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…
Manufacturer: Microline Surgical, Inc.
Category: Medical Device — Surgical Instruments
Hazard: sterility-compromise
infection-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

Lot Numbers: 70211 UDI: 00811099012115

Distribution

Distributed in 5 states:

Part of a larger recall action

This product is one of 2 recalled by Microline Surgical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Microline Surgical, Inc.

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Same hazard · sterility compromise