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

Maryland Bipolar Forceps,is4000 recalled by Intuitive Surgical

Intuitive Surgical is recalling Maryland Bipolar 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: 471172 Part Number: 471172-16 UDI-DI code: 00886874119792 Batch Numbers: K10230831 K11230831 K12230831 K16240508 K17240508 K18240508 Model Number: 471172 Part Number: 471172-17 UDI-DI code: 00886874119792 Batch Numbers: K10221030 K10221122 K10221128 K10221212 K10221218 K10230103 K10230122 K10230129 K10230201 K10230205 K10230212 K10230219 K10230226 K10230302 K10230427 K10230504 K10230510 K10230515 K10230518 K10230526 K10230601 K10230608 K10230615 K10230622 K10230629 K10230706 K10230713 K10230714 K10230720 K10230727 K10230803 K10230810 K10230817 K10230824 K10230907 K10230914 K10230921 K10230928 K10231005 K10231012 K10231027 K10231109 K10231123 K10231201 K10231213 K10231214 K10231218 K10240104 K10240111 K10240118 K10240120 K10240125 K10240201 K10240208 K10240215 K10240229 K10240314 K10240327 K10240404 K10240410 K10240418 K10240425 K10240502 K10240515 K10240516 K10240523 K10240530 K10240603 K10240606 K10240613 K10240618 K10240702 K10240703 K10240708 K11221030 K11221212 K11221218 K11230122 K11230205 K11230302 K11230310 K11230504 K11230515 K11230518 K11230526 K11230601 K11230608 K11230615 K11230622 K11230629 K11230706 K11230713 K11230727 K11230803 K11230810 K11230817 K11230824 K11230907 K11230914 K11230921 K11230928 K11231005 K11231019 K11231102 K11231109 K11231123 K11231201 K11231214 K11240104 K11240111 K11240118 K11240125 K11240201 K11240215 K11240229 K11240404 K11240418 K11240502 K11240509 K11240523 K11240530 K11240606 K11240613 K11240618 K11240702 K11240711 K12221218 K12230122 K12230205 K12230515 K12230518 K12230601 K12230608 K12230615 K12230622 K12230629 K12230727 K12230803 K12230810 K12231005 K12231019 K12231214 K12240111 K12240201 K12240404 K12240502 K12240509 K12240523 K12240530 K12240711 K13230122 K13230515 K13230518 K13230601 K13230622 K13230810 K13231005 K13231019 K13240404 K13240509 K13240711 K14230122 K14230515 K14230518 K14230525 K15230122 K15230515 K15230525

Quantity recalled68,458

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-0876-2025
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,MARYLAND BIPOLAR FORCEPS,IS4000 REF 471172

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 Maryland Bipolar Forceps,is4000 recalled?

Yes. Intuitive Surgical recalled Maryland Bipolar Forceps,is4000 on 19 Dec 2024. The recall is Class II and its status is Ongoing. Recall number Z-0876-2025.

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: 471172 Part Number: 471172-16 UDI-DI code: 00886874119792 Batch Numbers: K10230831 K11230831 K12230831 K16240508 K17240508 K18240508 Model Number: 471172 Part Number: 471172-17 UDI-DI code: 00886874119792 Batch Numbers: K10221030 K10221122 K10221128 K10221212 K10221218 K10230103 K10230122 K10230129 K10230201 K10230205 K10230212 K10230219 K10230226 K10230302 K10230427 K10230504 K10230510 K10230515 K10230518 K10230526 K10230601 K10230608 K10230615 K10230622 K10230629 K10230706 K10230713 K10230714 K10230720 K10230727 K10230803 K10230810 K10230817 K10230824 K10230907 K10230914 K10230921 K10230928 K10231005 K10231012 K10231027 K10231109 K10231123 K10231201 K10231213 K10231214 K10231218 K10240104 K10240111 K10240118 K10240120 K10240125 K10240201 K10240208 K10240215 K10240229 K10240314 K10240327 K10240404 K10240410 K10240418 K10240425 K10240502 K10240515 K10240516 K10240523 K10240530 K10240603 K10240606 K10240613 K10240618 K10240702 K10240703 K10240708 K11221030 K11221212 K11221218 K11230122 K11230205 K11230302 K11230310 K11230504 K11230515 K11230518 K11230526 K11230601 K11230608 K11230615 K11230622 K11230629 K11230706 K11230713 K11230727 K11230803 K11230810 K11230817 K11230824 K11230907 K11230914 K11230921 K11230928 K11231005 K11231019 K11231102 K11231109 K11231123 K11231201 K11231214 K11240104 K11240111 K11240118 K11240125 K11240201 K11240215 K11240229 K11240404 K11240418 K11240502 K11240509 K11240523 K11240530 K11240606 K11240613 K11240618 K11240702 K11240711 K12221218 K12230122 K12230205 K12230515 K12230518 K12230601 K12230608 K12230615 K12230622 K12230629 K12230727 K12230803 K12230810 K12231005 K12231019 K12231214 K12240111 K12240201 K12240404 K12240502 K12240509 K12240523 K12240530 K12240711 K13230122 K13230515 K13230518 K13230601 K13230622 K13230810 K13231005 K13231019 K13240404 K13240509 K13240711 K14230122 K14230515 K14230518 K14230525 K15230122 K15230515 K15230525

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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