FDA Device recall Z-0063-2015
EndoWrist One Vessel Sealer used in conjunction with the da Vinci Si Surgical System IS3000
- FDA Device
- Class II
- terminated
- Published 2014-10-22
On 2014-10-22 the FDA classified a Class II recall of EndoWrist One Vessel Sealer used in conjunction with the da Vinci Si Surgical System IS3000 by Intuitive Surgical, citing intuitive Surgical is initiating a voluntary correction relating to the labeling and software associated with the EndoWrist. One Vessel Sealer for the da Vinci Si (IS3000) Surgica….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0063-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-09-17 |
| Published | 2014-10-22 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Intuitive Surgical |
| Distribution | US |
Product
EndoWrist One Vessel Sealer used in conjunction with the da Vinci Si Surgical System IS3000. The Endo Wrist One Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Si Surgical System and the ERBE VIO 300 D electrosurgical generator. It is intended for grasping and blunt dissection of tissue and for bipolar coagulation and mechanical transection of vessels up to 7 mm in diameter and tissue bundles that fit in the jaws of the instrument.
Reason
Intuitive Surgical is initiating a voluntary correction relating to the labeling and software associated with the EndoWrist. One Vessel Sealer for the da Vinci Si (IS3000) Surgical System.
Identifiers
| code_info | Part Number: PN 410322-04, -05 Serial Numbers: SH1484 SH1879 SH1875 SH1485 USG332 SH0561 USG803 SH1406 SH14…Part Number: PN 410322-04, -05 Serial Numbers: SH1484 SH1879 SH1875 SH1485 USG332 SH0561 USG803 SH1406 SH1405 SH0034 SH0554 SH0554 USG160 USG575 SH0908 SH2066 SH1455 SH0975 SH1475 SH1168 SH1552 SH0608 SH0608 SH1756 SH1716 USG071 USG038 SH0607 SH1590 SH1686 SH1639 SH1688 SH1740 SH1932 USG323 SH1944 USG286 SH1945 SH2022 SH2085 SH1108 SH2047 USG257 USG435 USG183 SH2079 USG035 USG144 USG647 SH1590 USG641 SH0087 USG580 SH0389 USG106 SH1642 USG351 SH0280 SH1963 SH0566 USG551 USG566 USG636 SH2076 USG122 USG163 SH0084 USG706 USG563 SH0252 SH1494 SH1249 SH1588 SH1495 USG103 USG484 SH0329 SH1980 USG060 USG421 USG364 SH0148 USG398 SH0412 SH0881 SH1687 SH2154 SH1998 SH1802 SH1863 SH1939 SH2100 SH2128 SH0572 SH0208 SH1159 SH1592 SH0273 SH2143 SH1297 SH1852 SH2014 SH1941 SH2009 SH2015 SH2013 SH2027 SH2116 SH2056 SH2012 SH2161 SH2193 SH2209 SH0467 SH0238 USG605 SH1962 SH1757 SH187 |
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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-0063-2015%22
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