Summary
The FDA issued a Class II for 8MM,MEGA NEEDLE DRIVER,IS4000¿ REF 470194 by Intuitive Surgical, Inc.. Reason: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws..
Details
Source
Device Recall
External ID
Z-0858-2025
Action Date
2025-01-22
Status
Ongoing
Category
device
Product Description
8MM,MEGA NEEDLE DRIVER,IS4000¿ REF 470194
Lot/Code Info: Model Number: 470194 Part Number: 470194-06 UDI-DI code: 00886874112342 Batch Numbers: K10221113 K10221128 K10221204 K10221212 K10221218 K10230112 K10230205 K10230212 K10230217 K10230824 K10240418 K10240502 K10240523 K10240718 K10240801 K11221212 K11230112 K11230217 K11240418 K12230112 K12230217 K16240702 U10230217 Model Number: 470194 Part Number: 470194-08 UDI-DI code: 00886874112342 Batch Numbers: K10230302 K10230310 K10230316 K10230323 K10230405 K10230420 K10230511 K10230525 K10230601 K10230608 K10230615 K10230622 K10230706 K10230713 K10230720 K10230727 K10230810 K10230817 K10230907 K10230914 K10230921 K10230928 K10231012 K10231019 K10231027 K10231102 K10231109 K10231123 K10231130 K10231207 K10231214 K10240104 K10240111 K10240118 K10240125 K10240202 K10240208 K10240215 K10240314 K10240327 K10240404 K10240425 K10240509 K10240515 K10240523 K10240606 K10240613 K10240620 K10240627 K10240702 K10240822 K11230302 K11230310 K11230323 K11230720 K11230727 K11230914 K11231012 K11231027 K11231109 K11240118 K11240125 K11240314 K11240404 K11240509 K11240620 K11240822 K12230302 K12230914 K12240404 K12240509 K12240620 U10230517
Quantity Affected: 38,438
Reason for Recall
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Distribution
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
Type: Voluntary: Firm initiated
Recall Initiated: 2024-12-19
Company
Sunnyvale, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 249 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Intuitive Surgical, Inc. has 124 FDA actions in our database, including 73 recalls and 51 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Intuitive Surgical, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Intuitive Surgical, Inc. have FDA actions?
Intuitive Surgical, Inc. has 124 FDA actions in our database, including 73 recalls and 51 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0858-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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