The Recall Desk

Manufacturer

Gordian Surgical

1 recall in our database name Gordian Surgical as the manufacturing or recalling firm.

What the numbers show

Total
1
Critical
0
Severe
0
Most recent
2020-11-11

Of the 1 recalls from Gordian Surgical we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–1 of 1

  • HighFDA (Devices)·Z-0398-2021·2020-11-11

    Gordian Surgical Recalls TroClose 1200 Devices Due to High Endotoxin Levels

    Gordian Surgical is recalling 300 TroClose 1200 devices because endotoxin test results exceeded acceptable levels. The devices are used in endoscopic and laparoscopic surgeries.

    Product
    TroClose 1200 - Product Usage: intended for use in a variety of gynecologic, general and urologic endoscopic procedures, to create and maintain a port of entry and to facilitate the delivery of absorbable sutures and anchors through soft tissues of the body during endoscopic / la
    Category
    Medical Device
    Distribution
    Distributed nationwide