Facility

Microline Surgical, Inc

6 recall(s) on record — most severe on record: Class II.

Key facts

6recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	1000137656
Establishment type	Complaint File Establishment per 21 CFR 820.198
Location	50 Dunham Rd BEVERLY, MA, US 01915
Registration status	Active · expires 2026
Parent company	MICROLINE SURGICAL, INC. (owner-operator 9006317)
Brand names	Ten Comfort Disposable Scope Warmer

Activity by year

Recalls (6)

Devices registered here (1)

Laparoscopic Accessories, Gynecologic
Product code NWV (opens in a new tab) · Class I · Obstetrics/Gynecology · 21 CFR 884.1720

Recalls & enforcement

Class IIOngoing2024-11-05
A lot of ReNew Microscissor Tips exhibited a 2% rate of failure in terms of the heat shrink breaking off.
Class IITerminated2019-03-22
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.
Class IITerminated2017-11-01
Certain lots of disposable laparoscopic instrument tips may potentially have a compromised sterile barrier.
Class IITerminated2017-07-13
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.
Class IITerminated2014-05-12
Potential for the Fenestrated Grasper Tip jaw to break when force is applied to the jaw
Class IITerminated2014-04-14
Grasper jaw may break when force is applied to the jaw

All facilities operated by MICROLINE SURGICAL, INC.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Microline Surgical, Inc (FEI 1000137656) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1000137656-microline-surgical-inc/

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