Beverly, MA, United States
Microline Surgical, Inc. recalls
4 recalls recorded since 2018, most recently on 5 November 2024. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)1
Terminated or completed3
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 5 November 2024
- Reason
- A lot of ReNew Microscissor Tips exhibited a 2% rate of failure in terms of the heat shrink breaking off.
- Distribution
- Worldwide - US Nationwide in the state of OK and the country of Japan.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0663-2025
- Microscissor Tip (Disposable); Microline Catalog #: 3122.
Terminated Class II Medical devices
- Recall started
- 22 March 2019
- Terminated
- 30 July 2020
- Reason
- The shears exhibited a high rate of complete or intermittent failure to actuate. As a result, they do not perform their intended function in surgical procedures.
- Distribution
- The products were distributed to the following US states: ND and NY. The products were distributed to the following foreign countries: Germany, Netherlands.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1698-2019
- TLS2 Thermal Ligating Shears, Catalog Number 132-131D
Terminated Class II Medical devices
- Recall started
- 1 November 2017
- Terminated
- 17 September 2019
- Reason
- Certain lots of disposable laparoscopic instrument tips may potentially have a compromised sterile barrier.
- Distribution
- Distributed in the following U.S. states: FL, MA, MI, OH, OK TN, and Netherlands.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1741-2018, Z-1740-2018
- 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, g
- 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 cut
Terminated Class II Medical devices
- Recall started
- 13 July 2017
- Terminated
- 6 February 2020
- Reason
- 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.
- Distribution
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0507-2018
- 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 surgi
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.