CLASS II ONGOING Device recall · Reported 22 Jan 2025 · FDA Enforcement Report

Large Suturecut Needle Driver,is4000¿ recalled by Intuitive Surgical

Intuitive Surgical is recalling Large Suturecut Needle Driver,is4000¿, 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

Lot, batch or date codesModel Number: 470296 Part Number: 470296-05 UDI-DI code: 00886874112410 Batch Numbers: K10230217 Model Number: 470296 Part Number: 470296-08 UDI-DI code: 00886874112410 Batch Numbers: K10230302 K10230413 K10230420 K10230427 K10230824 K10231123 K10240229 K10240425 K10240627 K10240718 K16240613

Quantity recalled784

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-0864-2025
FDA event ID: 95938
Recalling firm: Intuitive Surgical, Sunnyvale, CA
Classification: Class II
Status: Ongoing
Recall initiated: 19 Dec 2024
FDA classified: 10 Jan 2025
Reported: 22 Jan 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

19 Dec 2024	Recall initiated by company
10 Jan 2025	Classified by FDA	+22 days
22 Jan 2025	Published in enforcement report	+12 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 increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Product as listed by the FDA

8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000¿ REF 470296

Where it was distributed

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

Nationwide Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts

Questions about this recall

Is Large Suturecut Needle Driver,is4000¿ recalled?

Yes. Intuitive Surgical recalled Large Suturecut Needle Driver,is4000¿ on 19 Dec 2024. The recall is Class II and its status is Ongoing. Recall number Z-0864-2025.

Why was it recalled?

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Which lots are affected?

Model Number: 470296 Part Number: 470296-05 UDI-DI code: 00886874112410 Batch Numbers: K10230217 Model Number: 470296 Part Number: 470296-08 UDI-DI code: 00886874112410 Batch Numbers: K10230302 K10230413 K10230420 K10230427 K10230824 K10231123 K10240229 K10240425 K10240627 K10240718 K16240613

Where was it sold?

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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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