| | Class 2 Device Recall da Vinci S, Si Monopolar Curved Scissors Instrument |  |
| Date Initiated by Firm | December 09, 2025 |
| Date Posted | March 30, 2026 |
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1696-2026 |
| Recall Event ID |
98383 |
| 510(K)Number | K050369 K180033 |
| Product Classification |
System, surgical, computer controlled instrument - Product Code NAY
|
| Product | Brand Name: da Vinci S, Si Monopolar Curved Scissors Instrument
Product Name: da Vinci S and Si Monopolar Curved Scissors Instrument
Model/Catalog Number: 420179
Software Version: N/A
Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories are intended for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories. Please refer to attached User Manual for additional details on intended use.
All da Vinci S/Si reusable instruments with jaws use mechanical tungsten cables and pulleys to transmit motion from the input discs to the housing (on the proximal chassis), through the main shaft, and the distal instrument tip (inside the patient).
Component: N/A |
| Code Information |
Lot Code: 420179: Monopolar Curved Scissors (Hot Shears)
GTIN: 00886874111505
FDA Medical Device Number: D088920
Material Number: 420179-10
Batch / System Numbers:
M10101102 SH0935
M10101201 SH0935
M10101202 SH1279
M10101203 SH0059
M10101204 USG294
M10101206 USG294
M10101206 SH1378
M10101214 USG022
M10101214 SH0035
M10101214 SH0495
M10110104 SH1279
M10110111 SH1378
M10110112 USG294
M10110113 SH0075
M10110121 SG704
M10110121 SH1279
M10110124 SH0495
M10110126 USG721
M10110126 SH1391
M10110127 USG721
M10110127 SH1279
M10110127 SH2144
M10110202 USG294
M10110202 SH0495
M10110203 SH2144
M10110208 SG704
M10110210 SH1378
M10110216 SH1368
M10110216 USG294
M10110216 SH1391
M10110217 SH0495
M10110217 SH1279
M10110222 SH1279
M10110228 SH0547
M10110228 USG721
M10110228 USG022
M10110228 SH1378
M10110228 SH1279
M10110301 SH1279
M10110303 SH0495
M10110304 USG294
M10110304 SH0729
M10110304 SH0761
M10110307 USG294
M10110308 USG294
M10110308 SH0035
M10110308 SH0495
M10110308 SH1279
M10110311 USG294
M10110311 SH2144
M10110315 USG294
M10110318 USG294
M10110318 SH0935
M10110318 SH1279
M10110323 USG022
M10110324 SH0059
M10110324 USG022
M10110324 SH0495
M10110328 USG294
M10110328 SH0935
M10110328 SH1279
M10110329 USG294
M10110329 SH0935
M10110331 SH0935
M10110405 SH1378
M10110413 USG294
M10110413 SH1279
M10110414 SG704
M10110414 SH0495
M10110420 SH1279
M10110425 SH0035
M10110426 SH0059
M10110428 USG022
M10110429 SG2026
M10110429 SH0035
M10110504 USG294
M10110512 USG294
M10110512 USG022
M10110512 SH2144
M10110517 USG294
M10110517 SH0495
M10110518 SH0035
M10110524 USG294
M10110524 SH1279
M10110525 USG294
M10110526 USG294
M10110526 SH1378
M10110602 SH1279
M10110603 SH1378
M10110614 SH1279
M10110616 SH1368
M10110617 SH1182
M10110617 SH0495
M10110621 SH2144
M10110622 SH0935
M10110623 SH0729
M10110624 SH1378
M10110629 USG294
M10110630 SH1279
M10110630 SH2144
M10110701 SH1378
M10110705 SH0035
M10110711 USG294
M10110712 SH1378
M10110712 SH0495
M10110715 SH1279
M10110715 SH2144
M10110718 SH0761
M10110721 SH0935
M10110728 SH0729
M10110728 SH0761
M10110729 USG721
M10110801 SH1279
M10110802 SH0935
M10110803 USG294
M10110803 USG022
M10110803 SH2144
M10110805 SG704
M10110805 SH0495
M10110808 SH0035
M10110809 USG721
M10110810 SH1279
M10110811 USG022
M10110811 SH0729
M10110812 USG721
M10110812 SH0729
M10110815 SH0935
M10110815 SH1279
M10110816 SG704
M10110816 USG721
M10110816 SH0729
M10110819 USG294
M10110822 SG704
M10110822 USG294
M10110823 SH0729
M10110824 SH0059
M10110824 SH0729
M10110824 SH0495
M10110825 USG721
M10110826 USG721
M10110829 SH1279
M10110830 USG022
M10110902 SG704
M10110902 SH1279
M10110902 SH0761
M10110906 USG022
M10110908 USG721
M10110908 SH1378
M10110908 SH1279
M10110909 SH0495
M10110913 USG721
M10110922 SH2144
M10110923 USG294
M10110923 SH0729
M10110930 SH0935
M10110930 SH0495
M10111003 SG704
M10111004 USG294
M10111005 USG294
M10111006 SH0729
M10111007 SH1368
M10111007 SH0035
M10111007 SH2144
M10111010 SH0935
M10111011 SH0495
M10111011 SH1279
M10111013 SH1378
M10111015 USG022
M10111017 SH1015
M10111018 SH1368
M10111018 SH1279
M10111019 USG294
M10111020 SH0547
M10111020 SH1279
M10111021 USG022
M10111027 SG704
M10111027 SH1378
M10111028 SH0059
M10111028 USG294
M10111028 SH2144
M10111031 SH1015
M10111104 SH1182
M10111107 SH0059
M10111107 SH0729
M10111107 SH0761
M10111108 SH1279
M10111108 SH2144
M10111109 SH0495
M10111111 SH0935
M10111114 USG294
M10111114 SH0729
M10111114 SH1279
M10111115 SG704
M10111115 USG294
M10111115 USG022
M10111116 SH0825
M10111117 SH0729
M10111117 SH1391
M10111117 SH0761
M10111118 SH0935
M10111122 SH0495
M10111122 SH0761
M10111123 SH1390
M10111123 USG294
M10111123 SH0035
M10111124 USG294
M10111129 SH0935
M10111130 SH1378
M10111201 SH1368
M10111202 USG294
M10111202 SH0729
M10111208 USG294
M10111208 SH1279
M10111212 SH1378
M10111213 SG704
M10111213 SH1279
M10111214 USG294
M10111214 SH0729
M10111214 SH1015
M10111216 SH0495
M10111221 USG294
M10111221 SH1378
M10120104 SH1182
M10120104 USG022
M10120104 SH1279
M10120105 USG294
M10120109 USG022
M10120111 SH2144
M10120112 USG721
M10120113 SH0495
M10120117 SH0495
M10120117 SH1279
M10120127 USG294
M10120130 SG704
M10120130 SH1279
M10120131 SH0729
M10120201 SH1390
M10120201 SH0729
M10120203 SH0935
M10120208 SH0729
M10120208 SH1279
M10120208 SH2144
M10120209 SH1378
M10120213 SH0495
M10120214 SH1279
M10120216 SG704
M10120216 SH0495
M10120217 SH1182
M10120217 SH0761
M10120221 SH0729
M10120222 SH1391
M10120224 SH1390
M10120224 USG294
M10120224 SH0729
M10120228 SH1279
M10120301 SH1015
M10120305 SH1279
M10120308 SH0729
M10120309 SH0935
M10120312 USG022
M10120312 SH0935
M10120312 SH1015
M10120313 SH0825
M10120315 SH1279
M10120315 SH2144
M10120316 SH1390
M10120316 SH0729
M10120316 SH1279
M10120317 SH1276
M10120320 SG704
M10120320 SH1368
M10120320 SH1378
M10120320 SH0729
M10120321 SG2026
M10120326 SH1076
M10120327 SH0935
M10120330 SH0059
M10120330 USG294
M10120402 SH1279
M10120403 SH0729
M10120403 SH0495
M10120404 SH1279
M10120409 SH2144
M10120411 SG2026
M10120411 SH2144
M10120412 SH0935
M10120412 SH0761
M10120413 SH1276
M10120416 SH1276
M10120423 USG294
M10120424 USG294
M10120424 SH0035
M10120425 SH1015
M10120425 SH1279
M10120426 SH1390
M10120501 SG704
M10120501 USG721
M10120503 USG022
M10120503 SH0729
M10120503 SH2144
M10120503 SH1276
M10120507 SH1279
M10120515 SH1182
M10120515 SG704
M10120515 USG721
M10120516 SH2144
M10120518 SH1368
M10120521 SH0761
M10120522 USG294
M10120524 USG294
M10120524 SH0729
M10120528 USG294
M10120528 SH1279
M10120529 SH0935
M10120529 SH1276
M10120604 SH0495
M10120606 SH1378
M10120607 SH0547
M10120607 SH0825
M10120612 USG294
M10120612 SH0035
M10120612 SH1279
M10120612 SH0761
M10120614 SH1390
M10120614 SH1368
M10120615 SH0729
M10120622 SG704
M10120622 SH1378
M10120622 SH1015
M10120626 USG294
M10120626 SH1279
M10120627 SH2144
M10120629 USG022
M10120629 SH1378
M10120629 SH0935
M10120629 SH0495
M10120629 SH0761
M10120702 SH0729
M10120702 SH1015
M10120705 SH0059
M10120705 SH1368
M10120705 USG294
M10120705 SH0495
M10120705 SH0761
M10120706 SH0935
M10120706 SH1391
M10120709 SH1390
M10120711 USG294
M10120711 SH1076
M10120713 USG294
M10120713 SH0729
M10120713 SH1279
M10120713 SH2144
M10120713 SH0761
M10120719 USG294
M10120719 SH1279
M10120723 SG704
M10120726 USG721
M10120730 SH0729
M10120730 SH0035
M10120730 SH0761
M10120731 SH1385
M10120801 SH2144
M10120802 SH0059
M10120807 SH1378
M10120808 SH1076
M10120809 SH0729
M10120809 SH1276
M10120810 USG294
M10120813 USG721
M10120815 SH1378
M10120821 SH0935
M10120822 SH1378
M10120822 SH0935
M10120823 USG022
M10120823 SH0729
M10120823 SH0761
M10120827 USG294
M10120828 SH1279
M10120903 SG704
M10120903 SH1276
M10120904 SH0495
M10120906 USG022
M10120911 SH0825
M10120919 SH1276
M10120920 SH0729
M10120920 SH0035
M10120925 SH0495
M10120925 SH1015
M10120928 SH0729
M10121001 SH0059
M10121002 SH1015
M10121004 USG294
M10121004 SH0729
M10121004 SH0495
M10121004 SH1385
M10121006 SH1391
M10121008 SH1279
M10121008 SH0761
M10121010 USG294
M10121012 USG294
M10121015 SH1378
M10121016 SH0495
M10121017 SH2144
M10121019 SH1368
M10121019 SH0825
M10121019 SH0935
M10121023 SH0729
M10121025 USG022
M10121029 SH0729
M10121029 SH1391
M10121029 SH0761
M10121031 USG294
M10121031 SH0935
M10121102 SH1279
M10121106 USG294
M10121106 USG721
M10121112 USG721
M10121113 USG689
M10121114 SG704
M10121114 USG294
M10121115 SH1390
M10121115 USG721
M10121115 SH1391
M10121121 USG294
M10121123 SH0059
M10121123 SH1390
M10121123 SH0495
M10121126 SH0935
M10121128 SH0059
M10121128 SH0729
M10121129 SH1276
M10121204 USG022
M10121205 SH2144
M10121206 SH0059
M10121215 SH1378
M10121215 SH1391
M10121215 SH0495
M10121218 USG294
M10121219 SH0547
M10130102 SH0547
M10130102 SH0059
M10130102 SH1279
M10130104 USG294
M10130108 SH1390
M10130108 USG022
M10130108 SH1279
M10130109 SH1368
M10130110 SH1368
M10130110 SH0935
M10130114 SH0729
M10130115 USG294
M10130116 SH1570
M10130116 SH0935
M10130117 SH0059
M10130117 SH0825
M10130117 SH0729
M10130117 SH0495
M10130118 USG294
M10130121 SH1390
M10130122 USG721
M10130122 SH1015
M10130123 SH1182
M10130124 SH1378
M10130124 SH0761
M10130205 USG022
M10130207 SH1391
M10130207 SH1015
M10130208 SG704
M10130211 USG689
M10130212 SH0729
M10130212 SH0761
M10130213 SH0547
M10130214 SH0729
M10130214 SH0495
M10130215 SH1182
M10130215 SH1378
M10130222 SH1390
M10130227 SH0495
M10130228 SH1622
M10130304 SH0825
M10130304 SH0495
M10130305 SH1570
M10130306 SH0761
M10130306 SH1276
M10130307 USG294
M10130308 SG2026
M10130308 SH1378
M10130308 SH1279
M10130313 USG294
M10130313 SH0935
M10130315 SH2144
M10130315 SH0761
M10130318 SH0059
M10130319 SH1279
M10130319 SH2144
M10130322 SH1279
M10130402 USG022
M10130404 USG022
M10130408 SH1378
M10130408 SH0729
M10130409 SH0059
M10130409 SH0761
M11110225 SG704
M11110323 SH1368
M11110517 SH0729
M11110517 SH1279
M11110517 SH2144
M11110525 SH0761
M11110526 SG704
M11110531 SH0495
M11110602 USG294
M11110602 SH0729
M11110623 SH1368
M11110623 SH1279
M11110625 SH0547
M11110625 USG294
M11110630 SG704
M11110630 USG294
M11110701 USG721
M11110701 SH0495
M11110701 SH0761
M11110808 SH0495
M11110808 SH0761
M11110809 USG294
M11110809 SH1391
M11110809 SH2144
M11110810 SH0761
M11110825 SH0059
M11110825 SH0761
M11110826 SH2144
M11110929 SG2026
M11110929 SH1279
M11111026 SH0729
M11111027 USG294
M11111028 SH0935
M11111028 SH0495
M11111117 USG022
M11111117 SH0729
M11111117 SH0761
M11111124 SH1015
M11111129 USG721
M11111130 USG294
M11111130 SH2144
M11120103 SH0059
M11120103 SH0729
M11120116 USG294
M11120116 SH0495
M11120126 SH0035
M11120127 SH1279
M11120130 USG294
M11120131 SH1182
M11120208 USG294
M11120209 SH0761
M11120210 SH0935
M11120213 SH0729
M11120214 SG2026
M11120330 USG294
M11120402 SH1391
M11120403 USG022
M11120404 SH1279
M11120517 USG294
M11120517 SH1279
M11120522 SH1368
M11120522 SH1276
M11120607 USG294
M11120607 USG022
M11120608 USG022
M11120717 USG294
M11120801 SH1015
M11120813 SH1368
M11120814 SH0729
M11120814 SH1276
M11120816 SH0729
M11120821 USG294
M11120906 SH1378
M11120919 USG689
M11120928 SH0935
M11120928 SH1276
M11121004 USG294
M11121004 SH1015
M11121004 SH1279
M11121010 USG294
M11121011 SH1182
M11121015 SH1378
M11121016 SH2144
M11121114 SH1557
M11121114 SH1378
M11121114 SH0935
M11121114 SH1279
M11121114 SH1276
M11121115 SH1076
M11121116 SH1279
M11121129 USG294
M11121129 SH0761
M11121130 SH0059
M11121203 USG294
M11121205 SH0035
M11121206 SH1604
M11121206 SH1385
M11121211 SG704
M11121211 SH0935
M11121211 SH2144
M11121214 SH1622
M11121218 SH0495
M11121219 SH1279
M11130112 USG294
M11130121 SH1276
M11130124 USG294
M11130124 SH0729
M11130124 SH1279
M11130207 USG721
M11130211 SH1378
M11130213 USG294
M11130214 SH2144
M11130225 SH0729
M11130226 USG721
M11130227 SH0059
M11130227 USG294
M11130228 SH0729
M11130301 SG704
M11130306 SH0059
M11130307 SH1378
M11130315 SH1378
M11130315 SH1391
M11130315 SH1015
M11130322 SH0729
M11130322 SH1276
M11130402 SH1279
M11130404 SH1015
M12110228 SH1279
M12120614 USG294
M12120614 SH1378
M12120801 SH1378
M12120816 SH1279
M12120906 SH1279
M12121011 SH1276
M12121105 SH0495
M12121207 SH1368
M12121211 SH0729
M12130109 SH0495
M12130111 SG704
M12130213 SH1279
M12130221 USG721
M12130226 SH0729
M12130226 SH0035
M12130320 USG294
M12130320 SH0935
M12130320 SH2144
M13120801 SH1390
M13120801 SH0495
M13121206 SH1378
M13130110 USG294
M13130110 SH0761
M13130111 USG721
M13130111 SH0935
M13130112 SH0035
M20111026 SH0935
M20111118 USG294
M20111206 SH0935
M20111206 SH1279
M20120116 USG294
M20120116 SH2144
M20120125 SH1391
M20120125 SH1076
M20120306 SH0495
M20120307 SH0935
M20120307 SH1279
M20120308 SH0035
M20120314 USG294
M20120314 SH0495
M20120514 USG721
M20120514 SH0825
M20120514 SH0729
M20120514 SH1276
S12110708 USG294
Material Number: 420179-12
Batch / System Numbers:
M10130601 SH1390
M10130603 SH0825
M10130603 SH0495
M10130605 USG022
M10130605 SH2144
M10130606 SH1570
M10130611 SH1390
M10130612 SH2144
M10130612 SH1276
M10130614 SH0935
M10130619 SG704
M10130620 SH1378
M10130621 SH0729
M10130622 SH1276
M10130703 SH1182
M10130703 SH0035
M10130704 SH2144
M10130710 SH1378
M10130713 SH0729
M10130713 SH1385
M10130713 SH0761
M10130716 SH0761
M10130716 SH1276
M10130717 SG2026
M10130717 SH0935
M10130717 SH1279
M10130718 SH0729
M10130722 USG294
M10130722 SH0761
M10130725 USG022
M10130725 SH1279
M10130726 SH1557
M10130726 USG294
M10130726 SH1391
M10130731 USG294
M10130731 SH0495
M10130801 SH1182
M10130802 SH0495
M10130805 SH0059
M10130805 SH0729
M10130806 USG294
M10130806 SH1391
M10130812 SH1276
M10130814 SH0035
M10130815 SH1378
M10130815 SH0729
M10130815 SH2144
M10130816 SH1570
M10130816 USG721
M10131105 USG294
M10131111 SH0935
M10131111 SH0729
M10131115 USG294
M10131115 SH1279
M10131119 USG022
M10131120 USG294
M10131120 SH1378
M10131120 SH1279
M10131121 SG704
M10131121 USG022
M10131122 SH0935
M10131122 SH0761
M10131123 SH0547
M10131123 SH1837
M10131123 SH1390
M10131128 SH0825
M10131128 SH1378
M10131202 SH0761
M10131202 SH1276
M10131204 SH1604
M10131206 SH1182
M10131206 SH0547
M10131206 SH2144
M10131207 SH0729
M10131207 SH1279
M10131207 SH1276
M10131211 USG294
M10131212 SH0059
M10131212 USG022
M10131212 SH0729
M10131212 SH1279
M10131214 SG704
M10131216 SH0729
M10131217 SH1570
M10131217 SH1557
M10131217 SH0729
M10131217 SH1279
M10131217 SH2144
M10131218 SH1368
M10140108 SH0761
M10140113 SH1378
M10140115 SH1390
M10140115 SH0935
M10140116 SH1557
M10140116 USG721
M10140116 SH1622
M10140117 USG721
M10140120 USG294
M10140120 USG022
M10140123 USG294
M10140123 SH1015
M10140212 SH0547
M10140212 SH1368
M10140212 USG294
M10140212 SH0761
M10140213 SG704
M10140213 SH0729
M10140213 SH0495
M10140213 SH1279
M10140217 SH1276
M10140306 SH1570
M10140328 SH1378
M10140328 SH1391
M10140401 SH1557
M10140401 SH0729
M10140402 SH1385
M10140402 SH1279
M10140416 SH1997
M10140416 SH1391
M11130527 SH1279
M11130603 SH0059
M11130603 SH0729
M11130606 USG721
M11130606 SH1385
M11130607 SH1837
M11130607 SH1279
M11130611 SH0059
M11130613 USG721
M11130613 SH1391
M11130614 SH1570
M11130614 SH1837
M11130618 SH0059
M11130618 SH1390
M11130622 SH1390
M11130622 SH1279
M11130622 SH1276
M11130703 SH1390
M11130708 USG022
M11130709 USG294
M11130710 SH1837
M11130710 SH0935
M11130710 SH1279
M11130711 SH0495
M11130712 USG294
M11130713 SH1368
M11130713 SH0729
M11130716 SH0059
M11130716 SH0729
M11130716 SH2144
M11130718 USG689
M11130718 USG294
M11130722 SH0825
M11130723 SH1378
M11130724 USG294
M11130726 SG704
M11130726 SH1557
M11130726 SH0761
M11130730 SH1390
M11130805 SH1368
M11130805 SG2026
M11130809 USG689
M11130813 SG704
M11130813 USG294
M11130814 SH1837
M11130814 USG022
M11130815 SH0729
M11130815 SH1015
M11130816 USG294
M11130816 SH0729
M11130816 SH1279
M11131111 SH0495
M11131111 USG518
M11131202 USG294
M11131202 SH1378
M11131204 SH0935
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Material Number: 420179-14
Batch / System Numbers:
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Material Number: 420179-15
Batch / System Numbers:
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Material Numbers: 420179-18
Batch / System Numbers:
N12180517 SH1182
N11180518 SH1182
N11180518 SH1570
N10180516 SH0059
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N11180517 SH0761
N10180619 SH0761
Material Number: 420179-22
Batch / System Numbers:
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N10181205 SH1182
N11181102 SH1182
N10190110 SH1182
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N10200317 SH0761
N10200218 SH0761
N10200601 SH0761
N10200810 SH0761
N10200622 SH0761
N10181217 USG518
N11180920 RSH0152
N11191104 RSH0152
Material Number: 420179-23
Batch / System Numbers:
N13190522 SH1182
N10191209 SH1182
N10200831 SH1182
N11201026 SH1182
N10201130 SH1182
N11201207 SH1182
N11210316 SH1182
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K10220104 SH1557
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K10220131 SH1390
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K11220522 SH0761
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K10220807 SH0761
K11220828 SH0761
K10230209 SH0761
N10211011 SH0761
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K10220918 SH1513
K10230209 SH1513
K10240125 SH1513
|
| FEI Number |
3001675293
|
Recalling Firm/ Manufacturer |
Intuitive Surgical, Inc. 1266 Kifer Rd Sunnyvale CA 94086-5304
|
| For Additional Information Contact | Shahbaz Khan 1-408-5232443 |
Manufacturer Reason for Recall | Due to increased complaints for broken/frayed grip cables for reusable instruments. |
FDA Determined Cause 2 | Process control |
| Action | On 12/29/2025, the firm sent via email an "Urgent: Medical Device Recall" Letter informing customers that intuitive has become aware of an increase in complaints regarding frayed or broken cables on some da Vinci S and Si reusable instruments.
Customers are instruct to:
1. Complete the attached Acknowledgement Form immediately and return it via fax or email to Intuitive as instructed on the form.
2. Identify and quarantine any affected product(s). Affected product(s) listed above may be returned by sending an email with quantities and lot numbers to your regional customer service.
3. Ensure to include the FSCA number ISIFA2025-15-R in the return notes.
4. Credit will be provided based on the number of remaining lives.
5. Shared or further distributed these products with other sites, make sure appropriate staff at the site receive and understand this notification so they locate and return their affected product.
For questions or concern, contact Clinical Sales Representative or contact Intuitive Customer Service at the numbers listed below:
" North and South America: (800) 876-1310, Option 3 (4 am to 5 pm PST) or mail: customerservice@intusurg.com.
" Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8 am to 6 pm CET) or eucs@intusurg.com
" South Korea: 02-3271-3200 (9 am to 6 pm KSTJ) or support.korea@intusurg.com
" Japan: 0120-56-5635 or 03-5575-1362 (9 am to 6 pm JST) or csjapan@intusurg.com
" India: +1-800-103-6952 (9 am to 6 pm IT)
" Taiwan: +0800-86-8181 (9 am to 6 pm CT) |
| Quantity in Commerce | 86904 |
| Distribution | Worldwide - U.S. Nationwide distribution in the states of CA, FL, GA, IA, IL, IN, KS, KY, LA, MA, MO, MS, NC, NJ, NY, OH, PA, TX, VA and WI. The countries of Argentina, Brazil, Canada, Chile, China, Cyprus, Czech Republic, Ecuador, France, Germany, Greece, Guadeloupe, India, Indonesia, Italy, Japan, Kuwait, Lebanon, Malaysia, Mexico, Pakistan, Philippines, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, South Korea, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam. |
| Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = NAY
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