Intuitive Surgical, Inc. recalls da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45
Robotic-assisted surgical system has Viewer Display manufactured with outdated firmware, may result in loss of one display-loss of 3D surgical field (depth perception) but 2D maintained, or loss of both…
Read the official notice →- Date
- 2026-02-18
- Country
- United States
- Brand
- Intuitive Surgical
- Product
- da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45
- Classification
- Class II
- Units
- US Nationwide distribution in the states of KS, AZ, MA, FL, MI, NC, IL, DC,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2026-04-08
USIntuitive Surgical, Inc. recalls Brand Name: da Vinci S, Si Permanent Cautery Hook Instrument Product Name: da Vinci S, Si Permanent Cautery Hook Instrument…
Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments
FDA · DeviceIntuitive Surgical, Inc.U.S. Nationwide distribution in the states of AR, CA, CT, FL, IA, IL, IN, KS,…Official notice →- US
Intuitive Surgical, Inc. recalls Brand Name: da Vinci S, Si Mega Needle Driver Instrument Product Name: da Vinci S, Si Mega Needle Driver Instrument Model/Catalog…
Due to increased complaints for broken/frayed grip cables for reusable instruments.
FDA · DeviceIntuitive Surgical, Inc.Worldwide - U.S. Nationwide distribution in the states of CA, FL, GA, IA, IL,…Official notice → - 2026-02-25
- US
Intuitive Surgical, Inc. recalls Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery.
An error event following the release of a software version for the surgical system that can result in loss of user interface content on an external monitor or tower monitor.
- 2026-02-11
- US
Intuitive Surgical, Inc. recalls Brand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vinci 5 Surgical System Model/Catalog Number: IS4000; IS4200;…
Due to a software implementation error that allowed instruments arms failing an important diagnostic test to remain in clinical use. This test was supposed to be used to detect Universal Surgical Manipulator insertion…
FDA · DeviceIntuitive Surgical, Inc.U.S.: AL, AR, CA, CO, CT, FL, ID, IL, IN, KS, KY, MD, MI, MN, MS, MO, NC, NJ,…Official notice → - 2026-01-28
- US
Intuitive 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 →
Other drugs & medical recalls in the United States
- 2026-02-25
- US
Olympus Corporation of the Americas recalls Olympus High Flow Insufflation Unit. Model Number: UHI-3. Used for insufflation of the abdominal cavity, and automatic…
Issue with software algorithm which may lead to overpressure events.
- 2026-02-18
- US
Steris Corporation recalls Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H
This is a sub-recall of event RES 96885. The supplier identified that during their manufacturing process for a limited batch of MNA-6x0 (adapter) components the incorrect configuration file was used.
FDA · DeviceSteris CorporationUS Nationwide distribution in the states of FL, NC, NY, OH, TN, TX, and VA.Official notice → - US
SUREPULSE MEDICAL LTD recalls Surepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate Monitor
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
FDA · DeviceSUREPULSE MEDICAL LTDWorldwide - US Nationwide distribution in the states of CT, TX and the…Official notice → - US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 7 M12 System Model Numbers: (1)722078, (2)722223, (3)722233; Software Version Number - All versions: R1.X, R2.X,…
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution - US Nationwide and the countries of Afghanistan,…Official notice → - US
Alphatec Spine, Inc. recalls ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 267-01-000-10-N UDI-DI code: 00190376541471; GMDN 12844 The ATEC…
Due a design issue where the navigated array connection geometry is incorrect.
FDA · DeviceAlphatec Spine, Inc.U.S. Nationwide distribution in the states of AZ, CA, FL, IL, IN, MA, MI, MO,…Official notice → - US
Laerdal Medical Corporation recalls Laerdal Compact Suction Unit 4 RTCA version (LCSU 4 RTCA) 1) LCSU 4, 800 ml, RTCA; Catalog Number: 880052; 2) LCSU 4, 300 ml, RTCA;…
units manufactured in a limited time period may emit electromagnetic noise beyond the acceptable limits for RTCA application specified in RTCA DO-160G Chapter 21, Equipment Category M.
FDA · DeviceLaerdal Medical CorporationWorldwide distribution - US Nationwide and the countries of Denmark, Sweden,…Official notice →