Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.
This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.
8MM,LARGE HEM-O-LOK CLIP APPLIER,IS4000¿ REF 470230
Why it was recalled
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Is your unit affected?
The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.
A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.
Show the FDA's listed lot / code information
Model Number: 470230 Part Number: 470230-12 UDI-DI code: 00886874112380 Batch Numbers: K10230103 K10230122 K10230123 K10230212 K10230226 K10230302 K10230310 K10230315 K10230323 K10230405 K10230420 K10230427 K10230504 K10230511 K10230518 K10230525 K10230602 K10230608 K10230615 K10230622 K10230706 K10230713 K10230727 K10230803 K10230810 K10230817 K10230921 K10231005 K10231012 K10231019 K10231027 K10231109 K10231123 K10231130 K10231207 K10231214 K10231218 K10240119 K10240125 K10240208 K10240215 K10240222 K10240229 K10240307 K10240327 K10240404 K10240411 K10240418 K10240516 K10240523 K10240606 K10240620 K10240627 K10240702 K10240711 K10240718 K10240808 K10240822 K11230103 K11230108 K11230212 K11230302 K11230315 K11230511 K11230518 K11230615 K11230622 K11230727 K11230817 K11230921 K11231005 K11231123 K11231214 K11240119 K11240125 K11240229 K11240404 K11240523 K11240620 K12230103 K12230108 K12230315 K12231116 K12240125 K12240404 K13230108 Model Number: 470230 Part Number: 470230-14 UDI-DI code: 00886874112380 Batch Numbers: K10230914
Recall status
Ongoing — the recall is still being carried out.
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
Recall record
- Recalling firm
- Intuitive Surgical, Inc.
- Product type
- Devices
- Recall number
- Z-0861-2025
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Letter
- Origin
- Sunnyvale, CA
- Recall initiated
- 2024-12-19
What to do
Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.
Also available: structured data (JSON-LD) · recall record (JSON)
What this is — and is not
A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.
To report a problem you experienced, use
FDA MedWatch.
Verify this record at FDA recalls ·
Recall Z-0861-2025 · Source: openFDA enforcement.