Intuitive Surgical, Inc. recalls 8MM, Small Graptor REF 470318 Is a grasping retractor Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of…
Due to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments
Read the official notice →- Date
- 2025-01-22
- Country
- United States
- Brand
- Intuitive Surgical
- Product
- 8MM, Small Graptor REF 470318 Is a grasping retractor Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of…
- Classification
- Class II
- Units
- U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Intuitive Surgical recalls
- 2026-01-21
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Access Port System tray may develop cracks potentially resulting in a sterility breach.
FDA · DeviceIntuitive Surgical, Inc.Worldwide - US Nationwide distribution including in the states of Alabama,…Official notice →- 2025-12-31
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Intuitive Surgical, Inc. recalls da Vinci 5, Surgeon Console Column Motor Connector; ASSY,DV5 CONSOLE,SSC,IS5000; Part Number: 380730-40
Surgical system Error 23062 due to connector1) Partially damaged "Potential problem with ergonomics: Disable - Retry " or 2) Failed "Disable Ergonomics: Viewer, headrest, armrest, and pedal tray position cannot be…
FDA · DeviceIntuitive Surgical, Inc.US Nationwide distribution in the states of MN, FL, CO, CA, NC, KS, TX, SC,…Official notice → - 2025-03-19
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Intuitive Surgical, Inc. recalls Brand Name: Da Vinci 5 Product Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedals Model/Catalog Number: 380730 Software Version: N/A . Refer…
Due to an increase in complaints concerning foot tray pedal spring failing resulting in the pedal remaining pressed
FDA · DeviceIntuitive Surgical, Inc.Worldwide distribution - US Nationwide and the countries of Alaska, Arizona,…Official notice → - 2025-01-22
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Intuitive Surgical, Inc. recalls 8MM,HORIZON SMALL CLIP APPLIER,IS4000¿ REF 470401
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
FDA · DeviceIntuitive Surgical, Inc.U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado,…Official notice → - 2024-09-04
- US
Intuitive Surgical, Inc. recalls Ion Endoluminal System, REF: 380748-65
There is a potential that the robotic system's instrument cart arm may contain screws that may potentially fail which could result in uncontrolled motion of a catheter inside a patient's airways.
FDA · DeviceIntuitive Surgical, Inc.US Nationwide distribution in the states of AZ and CA.Official notice → - 2024-04-17
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Intuitive Surgical, Inc. recalls Patient Cart, Part: 380601, a component of the da Vinci SP Surgical System, Model: SP1098
Surgical system may have inadequately welded top and/or bottom belts in the link 2 of the entry guide manipulator assembly/instrument arm joints, that may cause the following, 1) Top Failure: internal tissue injuries,…
FDA · DeviceIntuitive Surgical, Inc.US: VA, CA, NH, FL, NY, CO, AL, KY, MD, NC, NJ, OH, SC, SD, TN, WA, WI, WV,…Official notice →
Other drugs & medical recalls in the United States
- 2025-01-22
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Murata Vios, Inc. recalls muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate
During the set-up and workflow to begin Vios monitoring, it has been noticed that patient vital signs and ECG waveforms can become distorted and will flicker or flash very fast. This issue only occurs on the Central…
FDA · DeviceMurata Vios, Inc.Worldwide - US Nationwide distribution in the states of NY, LA and the country…Official notice → - US
IsoTis OrthoBiologics, Inc. recalls OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 Demineralized Bone Matrix, 10cc, REF 56300100.
Incorrect expiration date listed on the outer box, which does not align with the correct expiration date listed on the inner tray.
FDA · DeviceIsoTis OrthoBiologics, Inc.US Nationwide distribution in the states of IN, TN & TX.Official notice → - US
Sklar Instruments recalls ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE HEGAR DILATOR 11&12MM STRLCS25Model Number 96-0960; 2) ECONO STERILE…
Reports of various packaging issues that may result in a breach of the sterile barrier.
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SIN SISTEMA DE IMPLANTE NACIONAL S.A recalls Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N
Dental implant box incorrectly labels the diameter as 4,5 X 18,0 mm, but the internal label correctly labels the diameter as 4,0 X 18,0 mm; if the dentist drills the bone with the larger diameter stated on the box, the…
FDA · DeviceSIN SISTEMA DE IMPLANTE NACIONAL S.AUS distribution to states of: KY, CO, CA, NY, ID, NJ, FL, TX, KY, IL, OH; AND…Official notice → - US
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FDA · DeviceIsoTis OrthoBiologics, Inc.US Nationwide distribution in the states of AL, CA, MD. MN, MS, NC, NV, OH,…Official notice →