FDA Devices recall · Reported February 25, 2015
HARMONIC ACE Curved Shears Instructions for Use, 5MM, IS1200; for use with the da Vinci Standard Surgical System. Intended for soft tissue incisions when bleeding control and minimal thermal injury are desired. It is used in conjunction with the da Vinci Surgical System
Internal labeling review found that the IFU for the Harmonic Ace incorrectly instructs the user on how to manually open the grips.
Intuitive Surgical, Inc. recalled HARMONIC ACE Curved Shears Instructions for Use, 5MM, IS1200; for use with the da Vinci S… - a moderate-severity action.
HARMONIC ACE Curved Shears Instructions for Use, 5MM, IS1200; for use with the da Vinci S… was recalled by Intuitive Surgical, Inc. in February 25, 2015. Reason: Internal labeling review found that the IFU for the Harmonic Ace incorrectly instructs the user on how to man…. Check the official notice for the remedy. Verify recall #Z-1117-2015 with the FDA Devices before acting.
The recall
Intuitive Surgical, Inc. issued this moderate-severity FDA Devices recall-Internal labeling review found that the IFU for the Harmonic Ace incorrectly instructs the user on how to man….
- Moderate
- severity level
- Class II
- classification
- February 25, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1117-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1117-2015) was formally reported on February 25, 2015, with the manufacturer initiating the action on January 21, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Intuitive Surgical, Inc. is listed as the recalling firm, operating out of Sunnyvale, CA. Federal records list the affected scope as 12,467 - both sizes.
The documented reason for this recall is: Internal labeling review found that the IFU for the Harmonic Ace incorrectly instructs the user on how to manually open the grips. Distribution data in the federal record shows the product reached: Worldwide Distribution -- US, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, India, Israel, Italy, Japan, Lebanon, Me…. 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, 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 - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 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
HARMONIC ACE Curved Shears Instructions for Use, 5MM, IS1200; for use with the da Vinci Standard Surgical System. Intended for soft tissue incisions when bleeding control and minimal thermal injury are desired. It is used in conjunction with the da Vinci Surgical System
Reason for recall
Internal labeling review found that the IFU for the Harmonic Ace incorrectly instructs the user on how to manually open the grips.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1117-2015 |
| Date reported | February 25, 2015 |
| Date initiated | January 21, 2015 |
| Recalling firm | Intuitive Surgical, Inc. |
| Firm location | Sunnyvale, CA |
| Affected scope | 12,467 - both sizes |
| Distribution | Worldwide Distribution -- US, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, India, Israel, Italy, Japan, Lebanon, Mexico, Monaco, Nether… |
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-1117-2015) 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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Similar severity · nearest report date
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Methodology · Corrections · Archive as of August 2026