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…
Read the official notice →- Date
- 2026-02-11
- Country
- United States
- Brand
- Intuitive Surgical
- Product
- Brand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vinci 5 Surgical System Model/Catalog Number: IS4000; IS4200;…
- Classification
- Class II
- Units
- U.S.: AL, AR, CA, CO, CT, FL, ID, IL, IN, KS, KY, MD, MI, MN, MS, MO, NC, NJ,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 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.
- 2026-02-18
- US
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Robotic-assisted surgical system has Viewer Display manufactured with outdated firmware, may result in loss of one display-loss of 3D surgical field (depth perception) but 2D maintained, or loss of both…
FDA · DeviceIntuitive Surgical, Inc.US Nationwide distribution in the states of KS, AZ, MA, FL, MI, NC, IL, DC,…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 → - 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 →
Other drugs & medical recalls in the United States
- 2026-02-11
- US
Biomerieux Inc recalls VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam (cza02n) o Meropenem/Vaborbactam…
Potential risk of Quality Control failures and/or false resistant antibiotic results when testing isolates of Enterobacterales/Enterobacteriaceae species and/or Pseudomonas aeruginosa with the identified antibiotic…
- US
Beckman Coulter, Inc. recalls CellMek SPS Sample Preparation System, REF: C44603, with software
Sample preparation system designed to automate staining, lysing, cell washing has a software error that causes samples to be dispensed close to or touching tube bottoms, which could dislodge fluid line, result in…
FDA · DeviceBeckman Coulter, Inc.Worldwide - US Nationwide distribution in the states of MO, WA, MA, IL, AL,…Official notice → - US
Encore Medical, LP recalls EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705
942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay…
FDA · DeviceEncore Medical, LPUS: TX, IA, MI, MS, MA, RI, NJ, PA, NY, MO, OK, PR, AL, CAOfficial notice → - US
VANTIVE US HEALTHCARE LLC recalls PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dialysate System
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
- US
Olympus Corporation of the Americas recalls Brand Name: Single Use Electrosurgical Knife Product Name: Olympus Single Use Electrosurgical Knife KD-640L Model/Catalog…
A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.
- US
Beckman Coulter, Inc. recalls COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conjunction with a…
Due to specific lots of diluents contributing to elevated platelet Daily Checks background counts cycle with use with analyzers.
FDA · DeviceBeckman Coulter, Inc.Worldwide - U.S. Nationwide distribution including in the states of AL, AR,…Official notice →