CLASS II ONGOING Device recall · Reported 22 Jan 2025 · FDA Enforcement Report
Small Graptor recalled by Intuitive Surgical
Intuitive Surgical is recalling Small Graptor, distributed nationwide in the US. The recall was initiated on 19 Dec 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0924-2025
- FDA event ID
- 95939
- Recalling firm
- Intuitive Surgical, Sunnyvale, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 19 Dec 2024
- FDA classified
- 16 Jan 2025
- Reported
- 22 Jan 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Surgical Instruments
Timeline
| 19 Dec 2024 | Recall initiated by company | |
| 16 Jan 2025 | Classified by FDA | +28 days |
| 22 Jan 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
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.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusetts
Questions about this recall
Why was it recalled?
Due to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments
Which lots are affected?
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
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 95939| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Tenaculum Forceps recalled by Intuitive Surgical | Intuitive Surgical | Device Malfunction | Nationwide |
More recalls from Intuitive Surgical
All 256| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | da Vinci SP Instrument Arm Drape, SP recalled by Intuitive Surgical | Intuitive Surgical | Other | Nationwide |
| Device | CLASS II | Da Vinci ASSY, PSS, SP1098 recalled by Intuitive Surgical | Intuitive Surgical | Device Malfunction | Nationwide |
| Device | CLASS II | Da Vinci 5 Assy,DV5 Tower,IS5000 recalled by Intuitive Surgical | Intuitive Surgical | Device Malfunction | 49 states |
| Device | CLASS I | Intuitive SureForm 30 Gray Reloads Reference Numbers recalled | Intuitive Surgical | Other | 49 states |
| Device | CLASS II | Da Vinci X and Da Vinci Xi da Vinci X, Xi Surgical System recalled | Intuitive Surgical | Device Malfunction | Nationwide |
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