RegWardenFDA facility compliance records
Company

MICROLINE SURGICAL, INC.

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

Recalls by year

FDA actions on record by year2014: 2 recalls; 2017: 2 recalls; 2019: 1 recalls; 2024: 1 recalls2’14’15’162’17’181’19’20’21’22’231’24’25’26
  • Recalls (6)

Registered facilities (1)

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

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “MICROLINE SURGICAL, INC. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9006317-microline-surgical-inc/

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