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
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 AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusetts
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: 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?
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
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 95938This product is part of a recall event; the main page for the event is Horizon Small Clip Applier,is4000¿ recalled by Intuitive Surgical.
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