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

Medium-large Clip Applier,is4000¿ recalled by Intuitive Surgical

Intuitive Surgical is recalling Medium-large Clip Applier,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: 470327 Part Number: 470327-12 UDI-DI code: 00886874112465 Batch Numbers: K10221120 K10221212 K10230103 K10230108 K10230205 K10230212 K10230219 K10230226 K10230302 K10230330 K10230405 K10230413 K10230420 K10230427 K10230504 K10230509 K10230511 K10230518 K10230601 K10230608 K10230622 K10230629 K10230706 K10230713 K10230720 K10230727 K10230803 K10230805 K10230810 K10230817 K10230907 K10230914 K10230921 K10230928 K10231005 K10231012 K10231027 K10231109 K10231123 K10231130 K10231207 K10231214 K10231218 K10240111 K10240118 K10240201 K10240208 K10240215 K10240222 K10240229 K10240307 K10240314 K10240321 K10240327 K10240404 K10240418 K10240425 K10240509 K10240523 K10240606 K10240613 K10240711 K10240718 K10240725 K10240801 K10240808 K10240822 K11230103 K11230108 K11230212 K11230226 K11230504 K11230518 K11230525 K11230601 K11230608 K11230622 K11230629 K11230706 K11230720 K11230727 K11230810 K11230817 K11230928 K11231012 K11231027 K11231207 K11231214 K11231218 K11240208 K11240215 K11240222 K11240314 K11240404 K11240418 K11240509 K11240523 K11240613 K11240718 K12230226 K12230504 K12230622 K12230810 K12231012 K12231116 K12240314 K12240411 K12240509 K12240523 K12240718 K13221204 K13230108 K13230622 K13240411 K13240523 K13240718 K14230108 K14240411 Model Number: 470327 Part Number: 470327-14 UDI-DI code: 00886874112465 Batch Numbers: K10230914 K10240208

Quantity recalled30,316

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-0867-2025
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: Other Medical Devices

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,MEDIUM-LARGE CLIP APPLIER,IS4000¿ REF 470327

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 Medium-large Clip Applier,is4000¿ recalled?

Yes. Intuitive Surgical recalled Medium-large Clip Applier,is4000¿ on 19 Dec 2024. The recall is Class II and its status is Ongoing. Recall number Z-0867-2025.

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: 470327 Part Number: 470327-12 UDI-DI code: 00886874112465 Batch Numbers: K10221120 K10221212 K10230103 K10230108 K10230205 K10230212 K10230219 K10230226 K10230302 K10230330 K10230405 K10230413 K10230420 K10230427 K10230504 K10230509 K10230511 K10230518 K10230601 K10230608 K10230622 K10230629 K10230706 K10230713 K10230720 K10230727 K10230803 K10230805 K10230810 K10230817 K10230907 K10230914 K10230921 K10230928 K10231005 K10231012 K10231027 K10231109 K10231123 K10231130 K10231207 K10231214 K10231218 K10240111 K10240118 K10240201 K10240208 K10240215 K10240222 K10240229 K10240307 K10240314 K10240321 K10240327 K10240404 K10240418 K10240425 K10240509 K10240523 K10240606 K10240613 K10240711 K10240718 K10240725 K10240801 K10240808 K10240822 K11230103 K11230108 K11230212 K11230226 K11230504 K11230518 K11230525 K11230601 K11230608 K11230622 K11230629 K11230706 K11230720 K11230727 K11230810 K11230817 K11230928 K11231012 K11231027 K11231207 K11231214 K11231218 K11240208 K11240215 K11240222 K11240314 K11240404 K11240418 K11240509 K11240523 K11240613 K11240718 K12230226 K12230504 K12230622 K12230810 K12231012 K12231116 K12240314 K12240411 K12240509 K12240523 K12240718 K13221204 K13230108 K13230622 K13240411 K13240523 K13240718 K14230108 K14240411 Model Number: 470327 Part Number: 470327-14 UDI-DI code: 00886874112465 Batch Numbers: K10230914 K10240208

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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