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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95939

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
December 19, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Intuitive Surgical, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

8MM, Tenaculum Forceps REF 470207 Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of procedures to perform a variety of surgical tasks including manipulation and retraction of tissue.

Z-0923-2025
Recall number
Z-0923-2025
Initiated
December 19, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Intuitive Surgical, Inc.
Quantity
33,219

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments

Code information

Product Number: 470207 UDI-Di code: 00886874112366 Part Number and Version: 470207-04 Lot Numbers: S10131217 S10131218 Part Number and Version: 470207-07 Lot Numbers: S10140619 S10140622 S10140626 S10140718 S10140811 S10140912 S10141113 S10141121 S10150117 S10150202 Part Number and Version: 470207-08 Lot Numbers: N10160112 N10160128 N10160219 N10160316 N10160407 N10160420 N10160629 N10160705 N10160802 N10160824 N10160830 N10160914 N10160929 N10161011 N10161103 N10161109 N10161129 N10161212 N10170111 N10170201 N10170217 N10170308 N10170410 N10170509 N10170517 N10170612 N10170623 N10170705 N10170720 N10170809 N10170821 N10170829 N10170908 N10170927 N10171123 N10171204 N10180108 N10180119 N10180307 N10180308 N10180322 N10180404 N10180423 N10180516 N10180523 N10180528 N10180605 N10180613 S10141219 S10150207 S10150213 S10150310 S10150401 S10150416 S10150505 S10150518 S10150520 S10150618 S10150707 S10150715 S10150825 S10150903 S10150923 S10151002 S10160106 S10160120 S10160129 S10160225 S10160309 S10160323 S10160408 S10160510 S10160602 S10160613 S10160617 S10160623 S10160707 S10160719 S10160809 S10160822 S10170103 S10170522 S10170525 S11150610 S11150717 S11150730 S11150818 S11151008 S11151203 S11151219 S11160113 S12150807 S12150928 S12151112 S13151016 T10170907 T10170919 T10171219 T10180213 Part Number and Version: 470207-10 Lot Numbers: K10210726 K10210921 K10210927 K10211004 K10211011 K10211018 K10211025 K10211108 K10211116 K10211122 K10211129 K10211213 K10211220 K10220117 K10220214 K10220228 K10220307 K10220314 K10220321 K10220425 K10220502 K10220523 K10220530 K10220606 K10220613 K10220620 K10220704 K10220711 K10220718 K10220725 K10220802 K10220808 K10220815 K10220905 K10220926 K10221009 K10221016 K10221030 K10221102 K10221212 K10221218 K10230108 K10230205 K10230212 K10230226 K10230302 K10230310 K10230316 K10230323 K10230420 K10230427 K10230504 K10230511 K10230518 K10230525 K10230601 K10230608 K10230615 K10230706 K10230713 K10230803 K10230810 K10230928 K10231005 K10231109 K10231123 K10231130 K10240104 K10240111 K10240119 K10240208 K10240215 K10240222 K10240314 K10240321 K10240411 K10240417 K10240502 K10240509 K10240613 K10240620 K10240815 K10240822 K10240829 K10240905 K10240912 K11211220 K11221009 K11230108 K11230817 K11230928 K11231116 K11231123 K11240119 K11240829 K12231123 N10180620 N10180719 N10180727 N10180907 N10181011 N10181017 N10181203 N10181217 N10181219 N10181221 N10190116 N10190127 N10190218 N10190225 N10190305 N10190316 N10190324 N10190403 N10190410 N10190427 N10190511 N10190514 N10190522 N10190613 N10190722 N10190729 N10190812 N10190819 N10190826 N10190923 N10191028 N10191104 N10191125 N10191202 N10200106 N10200121 N10200206 N10200302 N10200305 N10200309 N10200323 N10200413 N10200420 N10200427 N10200511 N10200518 N10200525 N10200720 N10200810 N10200813 N10200817 N10200824 N10200831 N10200907 N10200909 N10200914 N10200921 N10200928 N10201012 N10201019 N10201110 N10201117 N10201123 N10201130 N10201207 N10201209 N10210104 N10210111 N10210118 N10210125 N10210202 N10210208 N10210215 N10210222 N10210301 N10210308 N10210316 N10210322 N10210412 N10210607 N10210621 N10210628 N10210719 N10210802 N10210823 N10210906 N10210913 N11200323 T10180718 T10181008 T10200106 T10200203 T10200220 T10200529 T10200630

Distribution pattern

U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MS, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WV, WI, and WY. The countries of Canada, Austria, Belgium, Denmark, Finland, France, French Guiana, Germany, Guadeloupe, Ireland, Luxembourg, Martinique, Monaco, Netherlands, Norway, Reunion, Sweden, Switzerland, United Kingdom, India, Japan, South Korea, Taiwan, Brazil, Argentina, Australia, Bulgaria, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Ecuador, Greece, Hong Kong, Hungary, Iceland, Israel, Italy, Kuwait, Lebanon, Malaysia, Malta, Mexico, New Zealand, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Thailand, Turkey, United Arab Emirates, Venezuela, Vietnam.

device · product 2 of 2

8MM, Small Graptor REF 470318 Is a grasping retractor Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of procedures to perform a variety of surgical tasks including manipulation and retraction of tissue.

Z-0924-2025
Recall number
Z-0924-2025
Initiated
December 19, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Intuitive Surgical, Inc.
Quantity
42028 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments

Code information

Product Number: 470318 UDI-Di code: 00886874112441 Part Number and Version: 470318-04 Lot Numbers: S10131209 S10131210 Part Number and Version: 470318-07 Lot Numbers: S10140617 S10140618 S10140619 S10140620 S10140717 S10140801 S10140812 S10140821 S10140823 S10140915 S10141008 S10141120 S10141205 S10141219 S10150108 S10150120 S10150122 S10150206 S10150212 S11140620 Part Number and Version: 470318-08 Lot Numbers: N10151230 N10160104 N10160113 N10160203 N10160218 N10160219 N10160307 N10160317 N10160330 N10160404 N10160406 N10160420 N10160426 N10160525 N10160607 N10160616 N10160725 N10160726 N10160802 N10160810 N10160824 N10160901 N10160914 N10160927 N10161010 N10161020 N10161102 N10161111 N10161128 N10161209 N10170119 N10170203 N10170222 N10170309 N10170330 N10170419 N10170502 N10170512 N10170518 N10170612 N10170623 N10170703 N10170725 N10170728 N10170801 N10170802 N10170822 N10170823 N10170906 N10170914 N10171012 N10171101 N10171115 N10171124 N10171206 N10171219 N10171227 N10180122 N10180131 N10180209 N10180221 N10180228 N10180312 N10180328 N10180410 N10180413 N10180511 N10180518 N10180606 N10180612 N10180613 N11170725 N11170728 N12170725 S10141211 S10150223 S10150312 S10150326 S10150408 S10150417 S10150430 S10150506 S10150611 S10150706 S10150717 S10150801 S10150827 S10150914 S10151007 S10151012 S10151028 S10151104 S10151215 S10160125 S10160217 S10160413 S10160512 S10160614 S10160622 S10160715 S10160719 S10160913 S10161221 S10170525 S10170710 S11150511 S11150603 S11150624 S11150728 S11150813 S11150904 S11150926 S11151023 S11151119 S11151201 S11151231 S12150819 S12150918 S12151001 S12151008 S12151019 S12151219 S13150820 T10170822 T10170929 T10171004 T10171030 T10171127 Part Number and Version: 470318-10 Lot Numbers: K10210921 K10210927 K10211004 K10211011 K10211018 K10211103 K10211108 K10211116 K10211117 K10211122 K10211206 K10211213 K10220217 K10220221 K10220228 K10220307 K10220314 K10220404 K10220425 K10220511 K10220516 K10220613 K10220725 K10220802 K10220808 K10220815 K10220912 K10220926 K10221016 K10221030 K10221102 K10221106 K10221113 K10221117 K10221118 K10230212 K10230219 K10230226 K10230420 K10230504 K10230511 K10230518 K10230525 K10230601 K10230608 K10230615 K10230706 K10230713 K10230803 K10230817 K10230831 K10230907 K10230914 K10230921 K10230928 K10231012 K10231019 K10231027 K10231130 K10231207 K10240104 K10240116 K10240125 K10240222 K10240327 K10240404 K10240516 K10240523 K10240606 K10240711 K10240725 K10240822 K10240829 K10240905 K11211103 K11220110 K11220228 K11220511 K11220516 K11220912 K11220926 K11221030 K11230608 K12220511 K12221102 N10180620 N10180704 N10180711 N10180719 N10180823 N10180828 N10180831 N10180920 N10181001 N10181017 N10181022 N10181102 N10181106 N10181113 N10181115 N10181123 N10181128 N10181203 N10181206 N10181210 N10190103 N10190107 N10190129 N10190206 N10190211 N10190216 N10190222 N10190223 N10190226 N10190304 N10190307 N10190310 N10190322 N10190330 N10190407 N10190411 N10190425 N10190507 N10190515 N10190519 N10190521 N10190531 N10190602 N10190701 N10190715 N10190722 N10190729 N10190812 N10190819 N10190826 N10190902 N10190909 N10190917 N10190923 N10190930 N10191007 N10191028 N10191104 N10191125 N10191202 N10200106 N10200211 N10200302 N10200309 N10200317 N10200323 N10200330 N10200406 N10200413 N10200420 N10200427 N10200504 N10200629 N10200713 N10200727 N10200803 N10200810 N10200817 N10200928 N10201012 N10201019 N10201027 N10201110 N10201117 N10201123 N10201130 N10201207 N10201214 N10210104 N10210111 N10210118 N10210125 N10210202 N10210208 N10210215 N10210222 N10210301 N10210308 N10210316 N10210322 N10210405 N10210412 N10210503 N10210518 N10210531 N10210607 N10210621 N10210705 N10210719 N10210831 N10210906 N10210913 N11200323 N11200727 N11210503 N13210831 U10210805 U10220209 U10220301 U10220328 U10220506

Distribution pattern

U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MS, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WV, WI, and WY. The countries of Canada, Austria, Belgium, Denmark, Finland, France, French Guiana, Germany, Guadeloupe, Ireland, Luxembourg, Martinique, Monaco, Netherlands, Norway, Reunion, Sweden, Switzerland, United Kingdom, India, Japan, South Korea, Taiwan, Brazil, Argentina, Australia, Bulgaria, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Ecuador, Greece, Hong Kong, Hungary, Iceland, Israel, Italy, Kuwait, Lebanon, Malaysia, Malta, Mexico, New Zealand, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Thailand, Turkey, United Arab Emirates, Venezuela, Vietnam.