Unrated Medical device recall · FDA · Published September 22, 2020

Gordian Surgical TroClose 1200 Endotoxin Levels Too High - Recall

Gordian Surgical recalls TroClose 1200 surgical devices due to endotoxin levels exceeding safe limits in LAL tests. Affected units have specific lot numbers and expiration dates. Consumers should contact the manufacturer for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0398-2021Medical device Gordian Surgical ›

Recall notice

Endotoxin test results found above the acceptable levels in LAL test (above 20EU/device).

Take action

Contact the company

Recalling firmGordian SurgicalTchelet 17, Trendlines Building, Misgav · Misgav, Israel

✎ GovInfoNow plain-language explainer

Gordian Surgical is recalling TroClose 1200 surgical devices because endotoxin tests showed levels above the acceptable limit. This could pose a risk during surgery, though the recall does not specify if the hazard causes injury in normal use. Read more at govinfonow.com/recall/64235-gordian-surgical-troclose-1200-endotoxin-levels-too-high-recall.

Source Summary by GovInfoNow · govinfonow.com/recall/64235-gordian-surgical-troclose-1200-endotoxin-levels-too-high-recall · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0398-2021

Cite this page

“Gordian Surgical TroClose 1200 Endotoxin Levels Too High - Recall.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/64235-gordian-surgical-troclose-1200-endotoxin-levels-too-high-recall. Based on FDA recall #Z-0398-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0398-2021%22&limit=1).

The FDA announced on September 22, 2020, that Gordian Surgical is recalling TroClose 1200 devices due to endotoxin levels exceeding acceptable limits. The agency stated the recall was voluntary and initiated by the firm.

How to tell if you have it

Brand: Gordian Surgical
Product: TroClose 1200
Catalog Number: GSTC1200
Lot Numbers: AS200009/3 (Exp 14 FEB 2022), AS200012/4 (Exp 23 MAR 2022)
Quantity: 300 total devices

The hazard

Endotoxin test results found above the acceptable levels in LAL test (above 20EU/device).

Context

GovInfoNow's records show other recent recalls of similar products include Medline medical procedure kits with high endotoxin levels (2026-03-19) and Medtronic Neurosurgery Ventriculostomy Kit Recall: Endotoxin Risk (2026-06-17). Additional related actions include the recall of Medline Medical Procedure Kits with Neuro Sponges May Have High Endotoxin Levels on 2026-03-19.

How to tell if you have this one

Check for the catalog number GSTC1200 and lot numbers AS200009/3 (expiring Feb 2022) or AS200012/4 (expiring Mar 2022) on the device packaging.

Brand
Gordian Surgical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Contact Manufacturer
Reach out to Gordian Surgical for specific instructions on how to report the device and get replacement or refund.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 2 states.

FDA distribution: “US Nationwide distribution including in the states of Texas and Michigan.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Michigan, Texas.

Recall timeline

FDA terminated this recall 5 months after the firm started it.

Sep 22, 2020Firm started the recall
Nov 3, 2020FDA classified it Class II
Nov 11, 2020Published in FDA’s Enforcement Report
Feb 11, 2021FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

Latest medical device recalls

Keep exploring

More Gordian Surgical recalls

Link to this recall

<a href="https://govinfonow.com/recall/64235-gordian-surgical-troclose-1200-endotoxin-levels-too-high-recall">Gordian Surgical TroClose 1200 Endotoxin Levels Too High - Recall (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0398-2021 (September 22, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0398-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.