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

Force Bipolar,is4000 recalled by Intuitive Surgical

Intuitive Surgical is recalling Force Bipolar,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: 471405 Part Number: 471405-06 UDI-DI code: 00886874120767 Batch Numbers: K10221204 K10221212 K10221218 K10230111 K10230212 K10230219 K10230226 K10230302 K10230310 K10230413 K10230420 K10230504 K10230515 K10230518 K10230525 K10230531 K10230601 K10230608 K10230615 K10230622 K10230630 K10230706 K10230713 K10230727 K10230803 K10230810 K10230817 K10230824 K10230831 K10230914 K10230928 K10231005 K10231012 K10231019 K10231027 K10231102 K10231109 K10231123 K10231130 K10231218 K10240104 K10240111 K10240118 K10240124 K10240208 K10240215 K10240219 K10240222 K10240229 K10240307 K10240327 K10240404 K10240411 K10240415 K10240418 K10240419 K10240425 K10240509 K10240516 K10240520 K10240530 K10240711 K10240728 K10240815 K10240822 K11221204 K11221212 K11221218 K11230212 K11230226 K11230302 K11230310 K11230413 K11230420 K11230515 K11230518 K11230525 K11230601 K11230608 K11230615 K11230622 K11230706 K11230713 K11230727 K11230803 K11230810 K11230914 K11231005 K11231019 K11231109 K11231116 K11240104 K11240111 K11240118 K11240208 K11240229 K11240307 K11240411 K11240418 K11240509 K11240516 K11240530 K11240711 K11240815 K11240822 K11240829 K12221204 K12221218 K12230122 K12230212 K12230226 K12230302 K12230515 K12230518 K12230525 K12230608 K12230615 K12230622 K12230706 K12230713 K12230810 K12230914 K12231109 K12240104 K12240118 K12240208 K12240229 K12240307 K12240418 K12240509 K12240530 K12240711 K12240829 K13230212 K13230226 K13230302 K13230525 K13230608 K13230706 K13230713 K13240711 K14230212 K14230226 K14230302 K14230525 K14230706 K14240711 K15230226 K15230525 K16240508 K16240530 U10230626 U10230714 U10230803 U10231201 U10231214 U10240112 U10240126 U11230803

Quantity recalled46,759

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-0883-2025
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,FORCE BIPOLAR,IS4000 REF 471405

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

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: 471405 Part Number: 471405-06 UDI-DI code: 00886874120767 Batch Numbers: K10221204 K10221212 K10221218 K10230111 K10230212 K10230219 K10230226 K10230302 K10230310 K10230413 K10230420 K10230504 K10230515 K10230518 K10230525 K10230531 K10230601 K10230608 K10230615 K10230622 K10230630 K10230706 K10230713 K10230727 K10230803 K10230810 K10230817 K10230824 K10230831 K10230914 K10230928 K10231005 K10231012 K10231019 K10231027 K10231102 K10231109 K10231123 K10231130 K10231218 K10240104 K10240111 K10240118 K10240124 K10240208 K10240215 K10240219 K10240222 K10240229 K10240307 K10240327 K10240404 K10240411 K10240415 K10240418 K10240419 K10240425 K10240509 K10240516 K10240520 K10240530 K10240711 K10240728 K10240815 K10240822 K11221204 K11221212 K11221218 K11230212 K11230226 K11230302 K11230310 K11230413 K11230420 K11230515 K11230518 K11230525 K11230601 K11230608 K11230615 K11230622 K11230706 K11230713 K11230727 K11230803 K11230810 K11230914 K11231005 K11231019 K11231109 K11231116 K11240104 K11240111 K11240118 K11240208 K11240229 K11240307 K11240411 K11240418 K11240509 K11240516 K11240530 K11240711 K11240815 K11240822 K11240829 K12221204 K12221218 K12230122 K12230212 K12230226 K12230302 K12230515 K12230518 K12230525 K12230608 K12230615 K12230622 K12230706 K12230713 K12230810 K12230914 K12231109 K12240104 K12240118 K12240208 K12240229 K12240307 K12240418 K12240509 K12240530 K12240711 K12240829 K13230212 K13230226 K13230302 K13230525 K13230608 K13230706 K13230713 K13240711 K14230212 K14230226 K14230302 K14230525 K14230706 K14240711 K15230226 K15230525 K16240508 K16240530 U10230626 U10230714 U10230803 U10231201 U10231214 U10240112 U10240126 U11230803

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

Other products in this recall event

36 other products · FDA event 95938

This product is part of a recall event; the main page for the event is Horizon Small Clip Applier,is4000¿ recalled by Intuitive Surgical.

Reported	Class	Recall	Company	Reason	Where
22 Jan 2025	CLASS II	Horizon Small Clip Applier,is4000¿ recalled by Intuitive Surgical	Intuitive Surgical	Other	Nationwide
22 Jan 2025	CLASS II	Mega Suturecut Nd,is4000 recalled by Intuitive Surgical	Intuitive Surgical	Other	Nationwide
22 Jan 2025	CLASS II	Large Needle Driver, Is4000 recalled by Intuitive Surgical	Intuitive Surgical	Other	Nationwide
22 Jan 2025	CLASS II	Prograsp Forceps,is4000 recalled by Intuitive Surgical	Intuitive Surgical	Other	Nationwide
22 Jan 2025	CLASS II	Monopolar Curved Scissors, Is4000 recalled by Intuitive Surgical	Intuitive Surgical	Other	Nationwide
22 Jan 2025	CLASS II	Atrial Retractor Short Right,is4000¿ recalled by Intuitive Surgical	Intuitive Surgical	Other	Nationwide
22 Jan 2025	CLASS II	Fenestrated Bipolar Forceps,is4000¿ recalled by Intuitive Surgical	Intuitive Surgical	Other	Nationwide
22 Jan 2025	CLASS II	Long Tip Forceps,is4000 recalled by Intuitive Surgical	Intuitive Surgical	Other	Nationwide
22 Jan 2025	CLASS II	Black Diamond Micro Forceps,is4000 ¿ recalled by Intuitive Surgical	Intuitive Surgical	Other	Nationwide
22 Jan 2025	CLASS II	Resano Forceps,is4000 ¿ recalled by Intuitive Surgical	Intuitive Surgical	Other	Nationwide
22 Jan 2025	CLASS II	Mega Needle Driver,is4000¿ recalled by Intuitive Surgical	Intuitive Surgical	Other	Nationwide
22 Jan 2025	CLASS II	Cadiere Forceps,is4000 recalled by Intuitive Surgical	Intuitive Surgical	Other	Nationwide
22 Jan 2025	CLASS II	Prograsp Forceps,is4000 ¿ recalled by Intuitive Surgical	Intuitive Surgical	Other	Nationwide
22 Jan 2025	CLASS II	Maryland Bipolar Forceps,is4000 ¿ recalled by Intuitive Surgical	Intuitive Surgical	Other	Nationwide
22 Jan 2025	CLASS II	Debakey Forceps,is4000 ¿ recalled by Intuitive Surgical	Intuitive Surgical	Other	Nationwide
22 Jan 2025	CLASS II	Maryland Bipolar Forceps,is4000 recalled by Intuitive Surgical	Intuitive Surgical	Other	Nationwide
22 Jan 2025	CLASS II	Large Suturecut Needle Driver,is4000 recalled by Intuitive Surgical	Intuitive Surgical	Other	Nationwide
22 Jan 2025	CLASS II	Curved Bipolar Dissector,is4000 recalled by Intuitive Surgical	Intuitive Surgical	Other	Nationwide
22 Jan 2025	CLASS II	Micro Bipolar Forceps,is4000 recalled by Intuitive Surgical	Intuitive Surgical	Other	Nationwide
22 Jan 2025	CLASS II	Round Tip Scissors, Is4000 ¿ recalled by Intuitive Surgical	Intuitive Surgical	Other	Nationwide
22 Jan 2025	CLASS II	Force Bipolar,is4000 recalled by Intuitive Surgical	Intuitive Surgical	Other	Nationwide
22 Jan 2025	CLASS II	Curved Bipolar Dissector,is4000¿ recalled by Intuitive Surgical	Intuitive Surgical	Other	Nationwide
22 Jan 2025	CLASS II	Large Hem-o-lok Clip Applier,is4000¿ recalled by Intuitive Surgical	Intuitive Surgical	Other	Nationwide
22 Jan 2025	CLASS II	Potts Scissors, Is4000 recalled by Intuitive Surgical	Intuitive Surgical	Other	Nationwide
22 Jan 2025	CLASS II	Medium-large Clip Applier,is4000¿ recalled by Intuitive Surgical	Intuitive Surgical	Other	Nationwide
22 Jan 2025	CLASS II	Micro Bipolar Forceps,is4000 ¿ recalled by Intuitive Surgical	Intuitive Surgical	Other	Nationwide
22 Jan 2025	CLASS II	Large Suturecut Needle Driver,is4000¿ recalled by Intuitive Surgical	Intuitive Surgical	Other	Nationwide
22 Jan 2025	CLASS II	Cobra Grasper,is4000 recalled by Intuitive Surgical	Intuitive Surgical	Other	Nationwide
22 Jan 2025	CLASS II	Small Grasping Retractor,is4000¿ recalled by Intuitive Surgical	Intuitive Surgical	Other	Nationwide
22 Jan 2025	CLASS II	Tip-up Fenestrated Grasper,is4000¿ recalled by Intuitive Surgical	Intuitive Surgical	Other	Nationwide
22 Jan 2025	CLASS II	Dual Blade Retractor,is4000¿ recalled by Intuitive Surgical	Intuitive Surgical	Other	Nationwide
22 Jan 2025	CLASS II	Cadiere Forceps,is4000 ¿ recalled by Intuitive Surgical	Intuitive Surgical	Other	Nationwide
22 Jan 2025	CLASS II	Tenaculum Forceps,is4000¿ recalled by Intuitive Surgical	Intuitive Surgical	Other	Nationwide
22 Jan 2025	CLASS II	Mega Suturecut Nd,is4000¿ recalled by Intuitive Surgical	Intuitive Surgical	Other	Nationwide
22 Jan 2025	CLASS II	Long Bipolar Grasper,is4000 recalled by Intuitive Surgical	Intuitive Surgical	Other	Nationwide
22 Jan 2025	CLASS II	Fenestrated Bipolar Forceps,is4000 recalled by Intuitive Surgical	Intuitive Surgical	Other	Nationwide

More recalls from Intuitive Surgical

All 256

Reported	Class	Recall	Company	Reason	Where
22 Jul 2026Device	CLASS II	da Vinci SP Instrument Arm Drape, SP recalled by Intuitive Surgical	Intuitive Surgical	Other	Nationwide
1 Jul 2026Device	CLASS II	Da Vinci ASSY, PSS, SP1098 recalled by Intuitive Surgical	Intuitive Surgical	Device Malfunction	Nationwide
10 Jun 2026Device	CLASS II	Da Vinci 5 Assy,DV5 Tower,IS5000 recalled by Intuitive Surgical	Intuitive Surgical	Device Malfunction	49 states
13 May 2026Device	CLASS I	Intuitive SureForm 30 Gray Reloads Reference Numbers recalled	Intuitive Surgical	Other	49 states
13 May 2026Device	CLASS II	Da Vinci X and Da Vinci Xi da Vinci X, Xi Surgical System recalled	Intuitive Surgical	Device Malfunction	Nationwide

Other Other Medical Devices recalls

All 13,908

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14 Oct 2026Device	CLASS II	Plastics Tray kits recalled by Avid Medical	Avid Medical	Foreign Material	Nationwide
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14 Oct 2026Device	CLASS II	Pack Open Heart Cfh kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Sperm Ab Elisa (96 well plate test) recalled by DRG International	DRG International	Other	Nationwide
14 Oct 2026Device	CLASS III	BeneView Series recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide