FDA Device recall Z-0520-2014
Mega Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000
- FDA Device
- Class II
- terminated
- Published 2013-12-25
On 2013-12-25 the FDA classified a Class II recall of Mega Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000 by Intuitive Surgical, citing firm has become aware of the potential for detachment of the jaw insert for Large Needle Drivers and Mega Needle Drivers.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0520-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-11-15 |
| Published | 2013-12-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Intuitive Surgical |
| Distribution | US |
Product
Mega 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
Firm has become aware of the potential for detachment of the jaw insert for Large Needle Drivers and Mega Needle Drivers.
Identifiers
| code_info | Part number 400194 on da Vinci IS1200; Lot numbers: 710191 M10110114 710197 M10110204 710261 M10110217 711061 M101…Part number 400194 on da Vinci IS1200; Lot numbers: 710191 M10110114 710197 M10110204 710261 M10110217 711061 M10110307 711121 M10110321 711191 M10110425 712071 M10110523 712171 M10110603 801041 M10110621 801151 M10110725 801171 M10110728 801301 M10110810 803171 M10110816 804121 M10110831 805091 M10110909 805271 M10110920 M10090320 S10080609 M10090512 S10080621 M10090709 S10080729 M10090731 S10080812 M10090812 S10080822 M10090824 S10080910 M10090909 S10080918 M10091020 S10081010 M10091110 S10081029 M10091130 S10081106 M10091211 S10081114 M10100114 S10081201 M10100216 S10081215 M10100218 S10090106 M10100428 S10090210 M10100526 S10090303 M10101026 S10090318 M10101103 S10090320 M10101125 S10090410 S10090715 S10110308. Part number 420194 - used on IS2000: lot numbers: 510071 M10090629 S10080802 710191 M10090706 S10080818 710261 M10090724 S10080822 711061 M10090727 S10080902 711121 M10090731 S10080910 711151 M10090810 S10080917 711191 M10090825 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0520-2014%22
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