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
Read the official notice →- Date
- 2025-03-19
- Country
- United States
- Brand
- Intuitive Surgical
- Product
- Brand Name: Da Vinci 5 Product Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedals Model/Catalog Number: 380730 Software Version: N/A . Refer…
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide and the countries of Alaska, Arizona,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2026-01-28
USIntuitive Surgical, Inc. recalls Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model/Catalog Number: 490127 Software Version: N/A Product…
Due to probe bags that may have a compromised or incomplete sterile pouch seal.
FDA · DeviceIntuitive Surgical, Inc.U.S.: AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY,…Official notice →- 2026-01-21
- US
Intuitive Surgical, Inc. recalls da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1098,Box)
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
- US
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 → - 2025-01-22
- US
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
FDA · DeviceIntuitive Surgical, Inc.U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA,…Official notice → - US
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 →
Other drugs & medical recalls in the United States
- 2025-03-19
- US
Stryker Corporation recalls Stryker CinchLock Flex Knotless Anchor with Inserter and Suture, REF CAT02643, Sterile EO, Rx Only MR Safe CE 0197
Increase in complaints concerning "pullwire" breakage that may result in the broken pullwire remaining in the anchor implant body after deployment.
FDA · DeviceStryker CorporationWorldwide - US Nationwide distribution including in the states of Alabama,…Official notice → - US
Spectrum Medical Inc recalls Brand Name: Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors Product Name: Pump, Blood, Cardiopulmonary Bypass,…
Their is a potential of fluid leakage from the centrifugal blood pump pump during the priming procedure or during clinical procedures.
FDA · DeviceSpectrum Medical IncUS Nationwide distribution including in the states of Alabama, Arizona,…Official notice → - US
Beckman Coulter, Inc. recalls DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137
The DxI 9000 Access Immunoassay Analyzer wash wheel mixer may not spin freely within the idler pulley housing. When the problem occurs, the analyzer may generate a system event for a Wash Wheel Dispense Arm Spin Mixer…
- US
Philips Medical Systems Nederland B.V. recalls Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334;
Multiple problems identified with the software version leading to various scanning and image issues, and unintended device movement.
- US
ZOLL Medical Corporation recalls Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-80C; Software Version: NA Product Description: The Powerheart…
The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
FDA · DeviceZOLL Medical CorporationDomestic: Nationwide Distribution International: AE, AI, AM, AR, AT, AU, BD,…Official notice → - US
DePuy Mitek, Inc., a Johnson & Johnson Co. recalls COR Disposable Kit, 8 mm. Cartilage Transplant System.
Device is missing the pin in the graft loader component.
FDA · DeviceDePuy Mitek, Inc., a Johnson & Johnson Co.Domestic: Nationwide Distribution; Foreign: Austria, Belgium, Brazil,…Official notice →