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

Tenaculum Forceps,is4000¿ recalled by Intuitive Surgical

Intuitive Surgical is recalling Tenaculum Forceps,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: 470207 Part Number: 470207-10 UDI-DI code: 00886874112366 Batch Numbers: K10221218 K10230108 K10230205 K10230212 K10230226 K10230302 K10230310 K10230316 K10230323 K10230420 K10230427 K10230504 K10230511 K10230518 K10230525 K10230601 K10230608 K10230615 K10230706 K10230713 K10230803 K10230810 K10230928 K10231005 K10231109 K10231123 K10231130 K10240104 K10240111 K10240119 K10240208 K10240215 K10240222 K10240314 K10240321 K10240411 K10240417 K10240502 K10240509 K10240613 K10240620 K10240815 K10240822 K11230108 K11230817 K11230928 K11231116 K11231123 K11240119 K12231123

Quantity recalled11,162

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-0860-2025
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,TENACULUM FORCEPS,IS4000¿ REF 470207

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: 470207 Part Number: 470207-10 UDI-DI code: 00886874112366 Batch Numbers: K10221218 K10230108 K10230205 K10230212 K10230226 K10230302 K10230310 K10230316 K10230323 K10230420 K10230427 K10230504 K10230511 K10230518 K10230525 K10230601 K10230608 K10230615 K10230706 K10230713 K10230803 K10230810 K10230928 K10231005 K10231109 K10231123 K10231130 K10240104 K10240111 K10240119 K10240208 K10240215 K10240222 K10240314 K10240321 K10240411 K10240417 K10240502 K10240509 K10240613 K10240620 K10240815 K10240822 K11230108 K11230817 K11230928 K11231116 K11231123 K11240119 K12231123

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	Force Bipolar,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	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 Surgical Instruments recalls

All 3,809

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits: IV Start KIT recalled by Medline Industries	Medline Industries	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Packaging Defects	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled	ConMed	Other	Nationwide