FDA Devices recall · Reported June 19, 2013
Applied Medicals Epix¿ and Direct Drive Laparoscopic Graspers, Model Numbers C4130 and C4140. Used for grasping and manipulating tissue during general or laparoscopic surgery.
Applied Medical is conducting a voluntary recall on specific lot numbers of its Epix¿ and Direct Drive Laparoscopic Graspers. When the ratchet trigger is activated, if a great en…
Applied Medical Resources Corp recalled Applied Medicals Epix¿ and Direct Drive Laparoscopic Graspers, Model Numbers C4130 and C… - a moderate-severity action.
Applied Medicals Epix¿ and Direct Drive Laparoscopic Graspers, Model Numbers C4130 and C… was recalled by Applied Medical Resources Corp in June 19, 2013. Reason: Applied Medical is conducting a voluntary recall on specific lot numbers of its Epix¿ and Direct Drive Laparo…. Check the official notice for the remedy. Verify recall #Z-1521-2013 with the FDA Devices before acting.
The recall
Applied Medical Resources Corp issued this moderate-severity FDA Devices recall-Applied Medical is conducting a voluntary recall on specific lot numbers of its Epix¿ and Direct Drive Laparo….
- Moderate
- severity level
- 127K units
- affected scope
- Class II
- classification
- June 19, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1521-2013 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 moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
Applied Medicals Epix¿ and Direct Drive Laparoscopic Graspers, Model Numbers C4130 and C4140. Used for grasping and manipulating tissue during general or laparoscopic surgery.
Reason for recall
Applied Medical is conducting a voluntary recall on specific lot numbers of its Epix¿ and Direct Drive Laparoscopic Graspers. When the ratchet trigger is activated, if a great enough force is applied, there is a potential for the trigger to fracture and the jaws to remain in the closed position. The likelihood of this situation to occur and result in permanent patient injury is highly unlikely;
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1521-2013 |
| Date reported | June 19, 2013 |
| Date initiated | May 1, 2013 |
| Recalling firm | Applied Medical Resources Corp |
| Firm location | Rancho Santa Margarita, CA |
| Affected scope | 127,305 units |
| Distribution | Worldwide Distribution: USA Nationwide and countries of: Argentina, Austria, Australia, Bahrain, Belgium, Canada, Chile, Columbia, Denmark, Ecuador, Finland, France, Germany, Greece, India, Ireland, Israel, Italy, Jordan, Kuwait, Malaysia,… |
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-1521-2013) 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.
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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 (Moderate), 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