Microline Surgical, Inc.

Complete recall history across all FDA and CPSC categories — 7 total recalls

Microline Surgical, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (7)

FDA medical device enforcement actions by Microline Surgical, Inc.

Date Product Reason Class
Nov 5, 2024 Microscissor Tip (Disposable); Microline Catalog #: 3122. A lot of ReNew Microscissor Tips exhibited a 2% rate of failure in terms of t... Class II
Mar 22, 2019 TLS2 Thermal Ligating Shears, Catalog Number 132-131D The shears exhibited a high rate of complete or intermittent failure to actua... Class II
Nov 1, 2017 ReNew Dolphin Nose Disposable Dissector Tip, Catalog Number: 3312, UDI: 00811... Certain lots of disposable laparoscopic instrument tips may potentially have ... Class II
Nov 1, 2017 ReNew Endocut Scissor Disposable Tip, Catalog Number: 3142, UDI: 008110990121... Certain lots of disposable laparoscopic instrument tips may potentially have ... Class II
Jul 13, 2017 The ReNew Reusable Grasper and Dissector Tips are to be used with the ReNew L... The heat-shrink insulation tube may split during autoclave sterilization/re-s... Class II
May 12, 2014 Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips Ref 3221 Potential for the Fenestrated Grasper Tip jaw to break when force is applied ... Class II
May 12, 2014 Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips (Reusab... Potential for the Fenestrated Grasper Tip jaw to break when force is applied ... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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