Severity
Moderate
FDA Devices recall · Reported April 10, 2024
Under certain firing conditions, reloads were found to articulate in an uncontrolled manner potentially causing disruption to the staple line. The issue is related to components i…
Covidien, LP recalled Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT - a moderate-severity action.
Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT was recalled by Covidien, LP in April 10, 2024. Reason: Under certain firing conditions, reloads were found to articulate in an uncontrolled manner potentially causi…. Check the official notice for the remedy. Verify recall #Z-1457-2024 with the FDA Devices before acting.
The recall
Covidien, LP issued this moderate-severity FDA Devices recall-Under certain firing conditions, reloads were found to articulate in an uncontrolled manner potentially causi….
Sourced from official FDA Devices enforcement records. Verify recall #Z-1457-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-1457-2024) was formally reported on April 10, 2024, with the manufacturer initiating the action on February 14, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. Covidien, LP is listed as the recalling firm, operating out of North Haven, CT. Federal records list the affected scope as 30 Units.
The documented reason for this recall is: Under certain firing conditions, reloads were found to articulate in an uncontrolled manner potentially causing disruption to the staple line. The issue is related to components in impacted reloads that are not fully se… Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide and the countries of France, Hong Kong, Israel and Japan.. 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, 3 from FDA Devices - 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.
Where this recall sits in its category - 40,322 medical devices recalls on record
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.
Severity
Moderate
Affected scope
30 Units
Related Recalls
6
3 from same agency
Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT
Under certain firing conditions, reloads were found to articulate in an uncontrolled manner potentially causing disruption to the staple line. The issue is related to components in impacted reloads that are not fully secure, which leads to uncontrolled articulation. The issue can occur using either the Endo GIA" Ultra Universal Stapler or Signia" Stapling System.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1457-2024 |
| Date reported | April 10, 2024 |
| Date initiated | February 14, 2024 |
| Recalling firm | Covidien, LP |
| Firm location | North Haven, CT |
| Affected scope | 30 Units |
| Distribution | Worldwide distribution - US Nationwide and the countries of France, Hong Kong, Israel and Japan. |
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.
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.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported April 10, 2024. 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.