8MM,MEGA SUTURECUT ND,IS4000
Medical device recall Z-0880-2025. 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
- 88,840 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 increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
8MM,MEGA SUTURECUT ND,IS4000 REF 471309
88,840, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model Number: 471309 Part Number: 471309-15 UDI-DI code: 00886874119815 Batch Numbers: K10221113 K10221115 K10221212 K10221218 K10230103 K10230112 K10230122 K10230124 K10230129 K10230205 K10230212 K10230219 K10230720 K10230824 K10240621…
Every code shown here, 1,994 characters
Model Number: 471309 Part Number: 471309-15 UDI-DI code: 00886874119815 Batch Numbers: K10221113 K10221115 K10221212 K10221218 K10230103 K10230112 K10230122 K10230124 K10230129 K10230205 K10230212 K10230219 K10230720 K10230824 K10240621 K10240718 K11221113 K11221115 K11221212 K11230103 K11230112 K11230122 K11230202 K11230212 K11230217 K12221113 K12221212 K12230112 K12230122 K12230205 K12230217 K13221113 K13230217 K14230217 K15230217 K16240508 K16240531 U10230217 U10230223 Model Number: 471309 Part Number: 471309-16 UDI-DI code: 00886874119815 Batch Numbers: K10230302 K10230310 K10230316 K10230323 K10230330 K10230413 K10230420 K10230427 K10230504 K10230509 K10230511 K10230518 K10230525 K10230601 K10230608 K10230615 K10230622 K10230630 K10230706 K10230713 K10230727 K10230803 K10230810 K10230817 K10230831 K10230913 K10230914 K10230921 K10231005 K10231012 K10231019 K10231027 K10231102 K10231109 K10231123 K10231130 K10231207 K10231218 K10240104 K10240111 K10240118 K10240125 K10240215 K10240222 K10240229 K10240308 K10240314 K10240321 K10240322 K10240411 K10240418 K10240425 K10240502 K10240516 K10240523 K10240530 K10240606 K10240613 K10240614 K10240619 K10240711 K10240718 K10240822 K11230302 K11230310 K11230316 K11230323 K11230330 K11230413 K11230420 K11230511 K11230518 K11230601 K11230615 K11230706 K11230713 K11230727 K11230803 K11230810 K11230817 K11230913 K11230914 K11230921 K11231005 K11231012 K11231019 K11231027 K11231102 K11231109 K11231123 K11231130 K11231207 K11231218 K11240104 K11240111 K11240118 K11240125 K11240229 K11240308 K11240314 K11240321 K11240322 K11240411 K11240418 K11240502 K11240516 K11240523 K11240530 K11240606 K11240613 K11240711 K11240718 K11240822 K12230302 K12230310 K12230316 K12230323 K12230413 K12230420 K12230706 K12230810 K12230914 K12230921 K12231005 K12231012 K12231027 K12231109 K12231116 K12231123 K12231130 K12240104 K12240111 K12240118 K12240125 K12240321 K12240411 K12240418 K12240502 K12240516 K12240523 K12240530 K12240606 K12240613…
FDA’s list runs to 2,403 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. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and Puerto Rico. O.U.S: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and 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 10, 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 2,403 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.