Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported November 11, 2020
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 / laparoscopic surgery. The trocar may be used with or without visualization for primary and secondary insertions. It is comprised of a single patient use, bladeless Obturator designed to allow penetration and positioning at
Endotoxin test results found above the acceptable levels in LAL test (above 20EU/device).
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Gordian Surgical recalled TroClose 1200 - Product Usage: intended for use in a variety of gynecologic, general and … - a moderate-severity action.
TroClose 1200 - Product Usage: intended for use in a variety of gynecologic, general and … was recalled by Gordian Surgical in November 11, 2020. Reason: Endotoxin test results found above the acceptable levels in LAL test (above 20EU/device).. Check the official notice for the remedy. Verify recall #Z-0398-2021 with the FDA Devices before acting.
The recall
Gordian Surgical issued this moderate-severity FDA Devices recall-Endotoxin test results found above the acceptable levels in LAL test (above 20EU/device)..
- Moderate
- severity level
- Class II
- classification
- November 11, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0398-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0398-2021) was formally reported on November 11, 2020, with the manufacturer initiating the action on September 22, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. Gordian Surgical is listed as the recalling firm, operating out of Misgav, N/A. Federal records list the affected scope as 300 total devices.
The documented reason for this recall is: Endotoxin test results found above the acceptable levels in LAL test (above 20EU/device). Distribution data in the federal record shows the product reached: US Nationwide distribution including in the states of Texas and Michigan.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,422 medical devices recalls on record
Where this recall sits in the database
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
300 total devices
Related Recalls
6
0 from same agency
Product description
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 / laparoscopic surgery. The trocar may be used with or without visualization for primary and secondary insertions. It is comprised of a single patient use, bladeless Obturator designed to allow penetration and positioning at the required site within the abdomen, and several single use Cannulas, which serve as working channels for the procedure. The Cannulas are pre-loaded with two synthetic absorbable sutures, each attached to a synthetic absorbable anchor. The deployment of the anchors and sutures is achieved by utilizing a mechanism within the Obturator. The Cannula is 115 mm long and is compatible for use with laparoscopic devices of 5 - 12 mm outer diameter.
Reason for recall
Endotoxin test results found above the acceptable levels in LAL test (above 20EU/device).
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0398-2021 |
| Date reported | November 11, 2020 |
| Date initiated | September 22, 2020 |
| Recalling firm | Gordian Surgical |
| Firm location | Misgav, N/A |
| Affected scope | 300 total devices |
| Distribution | US Nationwide distribution including in the states of Texas and Michigan. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0398-2021) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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 / laparoscopic surgery. The trocar may be used with or without visualization for primary and secondary insertions. It is comprised of a single patient use, bladeless Obturator designed to allow penetration and positioning at the required site within the abdomen, and several single use Cannulas, which serve as working channels for the procedure. The Cannulas are pre-loaded with two synthetic absorbable sutures, each attached to a synthetic absorbable anchor. The deployment of the anchors and sutures is achieved by utilizing a mechanism within the Obturator. The Cannula is 115 mm long and is compatible for use with laparoscopic devices of 5 - 12 mm outer diameter.. Recalled by Gordian Surgical. Units affected: 300 total devices.
Why was this product recalled? ▼
Endotoxin test results found above the acceptable levels in LAL test (above 20EU/device).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 11, 2020. Severity: Moderate. Recall number: Z-0398-2021.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution including in the states of Texas and Michigan..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0398-2021) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported November 11, 2020.
- Source: FDA - Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC - Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA - National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.