Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported December 25, 2013
Large Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000. Manufactured by Intuitive Surgical, Sunnyvale, CA. EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing. Mega Needle Driver and Large Needle Driver instruments are part of the EndoWrist instrument famil
Firm has become aware of the potential for detachment of the jaw insert for Large Needle Drivers and Mega Needle Drivers.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Intuitive Surgical, Inc. recalled Large Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000. … - a moderate-severity action.
Large Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000. … was recalled by Intuitive Surgical, Inc. in December 25, 2013. Reason: Firm has become aware of the potential for detachment of the jaw insert for Large Needle Drivers and Mega Nee…. Check the official notice for the remedy. Verify recall #Z-0521-2014 with the FDA Devices before acting.
The recall
Intuitive Surgical, Inc. issued this moderate-severity FDA Devices recall-Firm has become aware of the potential for detachment of the jaw insert for Large Needle Drivers and Mega Nee….
- Moderate
- severity level
- Class II
- classification
- December 25, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0521-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0521-2014) was formally reported on December 25, 2013, with the manufacturer initiating the action on November 15, 2013. 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 94, 981 UPDATED 12/19/13 to 56, 469.
The documented reason for this recall is: Firm has become aware of the potential for detachment of the jaw insert for Large Needle Drivers and Mega Needle Drivers. Distribution data in the federal record shows the product reached: Worldwide Distribution - USA (nationwide and Puerto Rico) and Internationally to Finland, Belgium, Netherlands, UK, Czech Republic, Sweden, Germany, Austria, Switzerland, Norway, Denmark, South Korea, France, Ireland, a…. 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.
Medical Devices recalls over time
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.
Affected scope
94, 981 UPDATED 12/19/13 to 56, 469
Related Recalls
6
3 from same agency
Product description
Large Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000. Manufactured by Intuitive Surgical, Sunnyvale, CA. EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing. Mega Needle Driver and Large Needle Driver instruments are part of the EndoWrist instrument family and are intended for use in endoscopic manipulation and suturing.
Reason for recall
Firm has become aware of the potential for detachment of the jaw insert for Large Needle Drivers and Mega Needle Drivers.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0521-2014 |
| Date reported | December 25, 2013 |
| Date initiated | November 15, 2013 |
| Recalling firm | Intuitive Surgical, Inc. |
| Firm location | Sunnyvale, CA |
| Affected scope | 94, 981 UPDATED 12/19/13 to 56, 469 |
| Distribution | Worldwide Distribution - USA (nationwide and Puerto Rico) and Internationally to Finland, Belgium, Netherlands, UK, Czech Republic, Sweden, Germany, Austria, Switzerland, Norway, Denmark, South Korea, France, Ireland, and Slovakia. |
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-0521-2014) 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? ▼
Large Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000. Manufactured by Intuitive Surgical, Sunnyvale, CA. EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing. Mega Needle Driver and Large Needle Driver instruments are part of the EndoWrist instrument family and are intended for use in endoscopic manipulation and suturing.. Recalled by Intuitive Surgical, Inc.. Units affected: 94, 981 UPDATED 12/19/13 to 56, 469.
Why was this product recalled? ▼
Firm has become aware of the potential for detachment of the jaw insert for Large Needle Drivers and Mega Needle Drivers.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 25, 2013. Severity: Moderate. Recall number: Z-0521-2014.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA (nationwide and Puerto Rico) and Internationally to Finland, Belgium, Netherlands, UK, Czech Republic, Sweden, Germany, Austria, Switzerland, Norway, Denmark, South Korea, France, Ireland, and Slovakia..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0521-2014) 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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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 December 25, 2013. 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.