8MM, Small Graptor
Medical device recall Z-0924-2025. Published in FDA’s Enforcement Report on Jan 22, 2025.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jan 22, 2025. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 52 states named
- 42028 devices how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Due to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
42028 devices, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,993 characters
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…
FDA’s list runs to 3,802 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
The states and territories these words name
52 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Puerto Rico
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Dec 19, 2024.
- FDA classified it on Jan 16, 2025.
- FDA’s Enforcement Report published it on Jan 22, 2025.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Intuitive Surgical, Inc., of Sunnyvale, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 3,802 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.