CLASS II ONGOING Device recall · Reported 22 Jan 2025 · FDA Enforcement Report
Round Tip Scissors, Is4000 ¿ recalled by Intuitive Surgical
Intuitive Surgical is recalling Round Tip Scissors, 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-0850-2025
- 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, ROUND TIP SCISSORS, IS4000 ¿ REF 470007
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: 470007 Part Number: 470007-05 UDI-DI code: 00886874112168 Batch Numbers: K11221228 K10221228 K12230103 K10230122 K10230131 K10230302 K10230525 K10231012 K10231016 K13231027 K10231219 K11231221 K11240104 K10240117 K10240627
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.
More recalls from Intuitive Surgical
All 256| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | da Vinci SP Instrument Arm Drape, SP recalled by Intuitive Surgical | Intuitive Surgical | Other | Nationwide |
| Device | CLASS II | Da Vinci ASSY, PSS, SP1098 recalled by Intuitive Surgical | Intuitive Surgical | Device Malfunction | Nationwide |
| Device | CLASS II | Da Vinci 5 Assy,DV5 Tower,IS5000 recalled by Intuitive Surgical | Intuitive Surgical | Device Malfunction | 49 states |
| Device | CLASS I | Intuitive SureForm 30 Gray Reloads Reference Numbers recalled | Intuitive Surgical | Other | 49 states |
| Device | 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| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Plastics Tray kits recalled by Avid Medical | Avid Medical | Foreign Material | Nationwide |
| Device | CLASS II | Heart Prep Tray kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Pack Open Heart Cfh kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Sperm Ab Elisa (96 well plate test) recalled by DRG International | DRG International | Other | Nationwide |
| Device | CLASS III | BeneView Series recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |