The E-100 Generator (PN 374848-09) is a bipolar electrosurgical unit (ESU) designed to be used with the da…
Medical device recall Z-1484-2022. Published in FDA’s Enforcement Report on Aug 10, 2022.
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 Aug 10, 2022. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Completed its status, in FDA’s file
- Nationwide FDA’s word, and 45 states named
- 505 generators 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 preventative maintenance (PM) not being performed on E-100 generators which is a bipolar electrosugical unit designed to be used with the da Vinci Xi and X systems.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
The E-100 Generator (PN 374848-09) is a bipolar electrosurgical unit (ESU) designed to be used with the da Vinci Xi and X systems. The E-100 is installed on the Vision Cart and is connected to the system. The functions of the E-100 are initiated by the foot pedals on the Surgeon Console.
505 generators, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model Number: 374848-09 UDI -DI Code: 00886874116982 System Serial Numbers: SK1521 SK0614 SK4114 SL0615 SL0724 SK1178 SK4098 SL0719 SL0066 SK4353 SK4821 SK4939 SK4099 SL0673 SL0734 SL0736 SK3010 SL0682 SK3857 SK1277 SK4326 SL0666 SK4169…
Every code shown here, 2,000 characters
Model Number: 374848-09 UDI -DI Code: 00886874116982 System Serial Numbers: SK1521 SK0614 SK4114 SL0615 SL0724 SK1178 SK4098 SL0719 SL0066 SK4353 SK4821 SK4939 SK4099 SL0673 SL0734 SL0736 SK3010 SL0682 SK3857 SK1277 SK4326 SL0666 SK4169 SK4155 SK4327 SK3033 SK1537 SK4100 SK0917 SK4001 SL0581 SK3340 SK4156 SK3870 SL0744 SK1918 SK1227 SK4129 SK4061 SK4152 SK4301 SK4215 SK4217 SL0625 SK4380 SK2459 SK2460 SK0990 SK4146 SK1942 SK1403 SK0071 SK4219 SK4175 SK3391 SK2484 SK1103 SK3389 SK3405 SK0396 SK4254 SK0345 SK4613 SK0821 SK2767 SK3832 SK0549 SK2411 SK1505 SK1837 SK0765 SK4305 SK4081 SK3421 SK4290 SK4145 SK4118 SK4010 SK3066 SK4008 SK2289 SK0788 SK4351 SK4355 SK2076 SK4072 SK4069 SK2608 SL0753 SK4339 SK4282 SK2886 SK0902 SK3833 SK3874 SK2680 SK1494 SK2679 SK3173 SK2245 SK4256 SK4523 SK2209 SK2320 SK3220 SK0682 SK3765 SK4126 SK0679 SK2271 SK1762 SK1848 SK2420 SK1181 SK4180 SK4879 SK2491 SK3941 SK4111 SK1917 SK3917 SK4184 SK4147 SK3707 SK4880 SK3719 SK1594 SK0594 SK1456 SK2120 SK3881 SK1936 SK1935 SK0802 SK0093 SK2028 SK3715 SK4229 SK4211 SK4304 SL0751 SK3388 SK1400 SK0891 SK2066 SK2542 SK1543 SK2945 SK3744 SK4088 SK1581 SK0383 SK1331 SK0650 SK4103 SK1801 SK3277 SK4014 SK3877 SK2461 SK4164 SK3217 SK3902 SK1926 SK1424 SK1101 SK2617 SK4257 SK2280 SK1596 SK3859 SK0757 SK1346 SK0074 SK3888 SK3716 SK2918 SK1993 SK1992 SK1980 SK0261 SK3868 SK1154 SK3442 SK3962 SK3486 SK3958 SK1657 SK3451 SK3495 SK2152 SK1957 SK0729 SK4004 SK3963 SK1311 SK4428 SK1366 SK1856 SK3965 SK2812 SK1370 SK1873 SK1571 SK3971 SK3465 RSK8020 SK1249 SK0812 SK0532 SK1559 SK4134 SK1565 SK3882 SK4235 SK1874 SK3248 SK4263 SK4225 SK4223 SK4221 SK1053 SK0992 SK2283 SK4311 SK3544 SK1681 SK2853 SK1656 SK2147 SK0750 SK1165 SK2732 SK2197 SK1653 SK0438 SK3803 SK4295 SK3774 SK4341 SK3862 SK3708 SL0319 SK1352 RSK8013 SK3073 SK3044 SK3043 SK0607 SK2543 SK1287 SK4307 SK4300 SK0486 RSK8026 RSK8022 RSK8025 SK4068 SK1379 SK2016 RSK8031 SK4284 SK3690 SK3433 SK3936 SK4002 SK2709 SK1317 SK1350 SK0947 SK3373 SK2186 SK4261 SK4259…
FDA’s list runs to 3,634 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.
Worldwide distribution - U.S. Nationwide distribution in the states of AL, AK, AZ, AR, CA, CO, CT, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WI, and WY. The countries of Belgium, Denmark, Germany, Japan, Italy, Monaco, Norway, Sweden, Switzerland, United Kingdom.
The states and territories these words name
45 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Florida
- Georgia
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- Nebraska
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- 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?
Completed, in FDA’s file.
“The recall action reaches the point at which the firm has actually retrieved and impounded all outstanding product that could reasonably be expected to be recovered, or has completed all product corrections.”
openFDA, on “Completed”, 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 Jun 22, 2022.
- FDA classified it on Aug 1, 2022.
- FDA’s Enforcement Report published it on Aug 10, 2022.
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 3,634 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.