Microline Surgical, Inc.

Active in EUDAMED

United Statesfrom SRN EUDAMED SRN US-MF-000009811

Devices: 150
Registrations: EUDAMED
FDA recalls: 101 ongoing

At a glance

Counted by deviCERTS from registry records

EU certificates

1 of 1 in force.

See certificates

Market reach

European Union: EUDAMED actor, 1 certificate
United States: FDA recalls
Authorised rep.: MDSS GmbHDE

What Microline Surgical, Inc. makes

Microline Surgical, Inc. manufactures reusable and single-use endoscopic electrosurgical tools, including monopolar handpieces and electrodes, as well as rigid and flexible endoscopic scissors and tissue manipulation forceps. Their portfolio also includes metallic ligation clips designed for endoscopic procedures. The company produces reusable and disposable versions of these instruments, alongside electrosurgical power systems for use in surgical settings.

The company’s devices are classified under EU regulations as Class I or Class II/IIa, with corresponding authorisations through the FDA’s 510(k) and UDI programs. Their products are registered in the EU’s eudamed database, ensuring compliance with both U.S. and European medical device regulations. The manufacturer is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue150

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Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN: US-MF-000009811
DUNS number: 184080570
EUDAMED status: Active
EUDAMED registered name: Microline Surgical, Inc.
Registered address: 50, Dunham Road, 01915, Beverly, United States
Website: www.microlinesurgical.com
Email: customerservice@microlinesurgical.com
Phone: +1 978 922 9810
PRRC contact: Scott Marchand Davis(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredMDR 1next expiry 6 Sep 2031

DEKRA Certification B.V. 0344 1 certificate

3841767CE01 Active Reissued

Quality management system EU MDR

Issued
6 Sep 2026

Expires
6 Sep 2031

FDA recalls10

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 10 recalls initiated by MICROLINE SURGICAL, INC., the earliest on 2011-07-18 and the most recent on 2024-11-05. By recorded status: 1 ongoing and 9 terminated. The reasons filed fall into these groups: labeling or instructions for use, sterility or contamination, packaging, mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

2017 3
2018 0
2019 1
2020 0
2021 0
2022 0
2023 0
2024 1
2025 0
2026 0

5 initiated before 2017

2024
- 5 Nov 2024 Z-0663-2025 Class II Ongoing 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. Submission number: K213127
2019
- 22 Mar 2019 Z-1698-2019 Class II Terminated 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…
  Full distribution text
  The products were distributed to the following US states: ND and NY. The products were distributed to the following foreign countries: Germany, Netherlands.
  Submission number: K062257
2017
- 1 Nov 2017 Z-1740-2018 Class II Terminated 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. Submission number: K981389
- 1 Nov 2017 Z-1741-2018 Class II Terminated 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. Submission number: K962119
- 13 Jul 2017 Z-0507-2018 Class II Terminated 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,…
  Full distribution text
  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.
  Submission numbers: K962119, K974066
2014
- 12 May 2014 Z-1986-2014 Class II Terminated Potential for the Fenestrated Grasper Tip jaw to break when force is applied to the jaw Distribution: Worldwide Distribution-USA including the states of CA, HI, ID, MA, MI, MS, PA, TN, UT, and TX. and the countries of…
  Full distribution text
  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.
  Submission number: K981389
- 12 May 2014 Z-1987-2014 Class II Terminated Potential for the Fenestrated Grasper Tip jaw to break when force is applied to the jaw Distribution: Worldwide Distribution-USA including the states of CA, HI, ID, MA, MI, MS, PA, TN, UT, and TX. and the countries of…
  Full distribution text
  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.
  Submission number: K981389
- 14 Apr 2014 Z-1635-2014 Class II Terminated Grasper jaw may break when force is applied to the jaw Distribution: Worldwide Distribution - US including the states of TX, IL, TN and NY, and the country of Chile. Submission number: K981389
2011
- 18 Jul 2011 Z-3085-2011 Unclassified (pre-2012) Terminated Mislabeled: ReNew product number 3262 (Long Fenestrated Grasper) was packaged and labeled as product number 3642 (Super-Atrau Fenestrated Grasper). ReNew product number 3642 (Super-Atraumatic Fenestrated Grasper) was packaged and labeled as 3262 (Long Fenestrated Grasper Distribution: Worldwide Distribution - USA including FL, MI, MN, TN and WI and the countried of Canada, The Netherlands, Thailand, UK,…
  Full distribution text
  Worldwide Distribution - USA including FL, MI, MN, TN and WI and the countried of Canada, The Netherlands, Thailand, UK, Norway, and Italy.
  Submission number: K981389
- 18 Jul 2011 Z-3086-2011 Unclassified (pre-2012) Terminated Mislabeled: ReNew product number 3262 (Long Fenestrated Grasper) was packaged and labeled as product number 3642 (Super-Atrau Fenestrated Grasper). ReNew product number 3642 (Super-Atraumatic Fenestrated Grasper) was packaged and labeled as 3262 (Long Fenestrated Grasper Distribution: Worldwide Distribution - USA including FL, MI, MN, TN and WI and the countried of Canada, The Netherlands, Thailand, UK,…
  Full distribution text
  Worldwide Distribution - USA including FL, MI, MN, TN and WI and the countried of Canada, The Netherlands, Thailand, UK, Norway, and Italy.
  Submission number: K981389

Frequently asked questions

How many devices does MICROLINE SURGICAL, INC. have in the registry?

The registry currently lists 150 devices for MICROLINE SURGICAL, INC.. Devices recorded under merged duplicate company entries are counted once.

Which registries list MICROLINE SURGICAL, INC.'s devices?

Among its 50 most recently registered devices, MICROLINE SURGICAL, INC. has devices listed in EUDAMED (29 devices) and FDA GUDID (50 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do MICROLINE SURGICAL, INC.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for MICROLINE SURGICAL, INC.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for MICROLINE SURGICAL, INC.?

FDA recall records list 10 recalls initiated by MICROLINE SURGICAL, INC., the most recent initiated on 5 Nov 2024. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What EUDAMED certificates are recorded for MICROLINE SURGICAL, INC.?

EUDAMED lists 1 certificate for MICROLINE SURGICAL, INC. (quality management system) under MDR. The most recent was issued on 6 Sep 2026.

What are the newest devices from MICROLINE SURGICAL, INC. in the registry?

The most recently registered devices listed for MICROLINE SURGICAL, INC. include ReNew 3412, Microline 132-133D, ReNew 3362 and ReNew 3946.

Generated automatically from registry data and not verified by a human reviewer.