FDA Devices recall · Reported May 28, 2025
Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product code VASECR35
Firm has received an increase in reports regarding inadvertent instrument lockout during surgical procedures involving the device. If lockout occurs, the device will momentarily a…
Ethicon Endo-Surgery Inc recalled Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product … - a critical-severity action.
Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product … was recalled by Ethicon Endo-Surgery Inc in May 28, 2025. Reason: Firm has received an increase in reports regarding inadvertent instrument lockout during surgical procedures …. Check the official notice for the remedy. Verify recall #Z-1746-2025 with the FDA Devices before acting.
The recall
Ethicon Endo-Surgery Inc issued this critical-severity FDA Devices recall-Firm has received an increase in reports regarding inadvertent instrument lockout during surgical procedures ….
- Critical
- severity level
- 679K units
- affected scope
- Class I
- classification
- May 28, 2025
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1746-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope (see the Recall Profile below) is large enough to require multi-state distribution tracking. Distribution scope (see Distribution below) 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, 6 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.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product code VASECR35
Reason for recall
Firm has received an increase in reports regarding inadvertent instrument lockout during surgical procedures involving the device. If lockout occurs, the device will momentarily activate but will not cut or staple tissue, and additional steps will be required to open it and remove it from tissue. If user is unable to remove the device from the tissue, potential harms to patient include surgical delay, bleeding/hemorrhage, life threatening hemorrhage/hemorrhagic shock, and conversion to open therapy. Two adverse events received, including one patient death.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-1746-2025 |
| Date reported | May 28, 2025 |
| Date initiated | April 22, 2025 |
| Recalling firm | Ethicon Endo-Surgery Inc |
| Firm location | Blue Ash, OH |
| Affected scope | 678,526 |
| Distribution | US distribution nationwide. OUS distribution to EMEA, LATAM, APAC, and Canada. |
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-1746-2025) 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.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. 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.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Critical), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026