Intuitive Surgical, Inc. recalls Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System Model/Catalog Number: IS4000; IS4200 Software…
Due to manipulator containing screws with in the arm sub-assembly that my be susceptible to breaking.
Read the official notice →- Date
- 2026-05-13
- Country
- United States
- Brand
- Intuitive Surgical
- Product
- Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System Model/Catalog Number: IS4000; IS4200 Software Version:…
- Classification
- Class II
- Units
- Worldwide - U.S. Nationwide distribution including in the states of AK, AL,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2026-07-22
USIntuitive Surgical, Inc. recalls da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15
Robotic-assisted surgical system arm drapes may detach from the instrument arm due to an issue involving the drape rings located at the top of the product, which may expose a section of instrument arm, which may result…
FDA · DeviceIntuitive Surgical, Inc.Worldwide - US Nationwide distribution in the states of NJ, OR, NY, FL, AL,…Official notice →- 2026-07-01
- US
Intuitive Surgical, Inc. recalls Da Vinci ASSY, PSS, SP1098, Part Number: 380601
Operative components of surgical systems potentially distributed with E-brake retainer pin, so in event of a structural column failure, the E-brake pin would prevent E-brake engagement and may result in uncontrolled…
FDA · DeviceIntuitive Surgical, Inc.Worldwide - US Nationwide distribution including in the states of CA, GA, OH,…Official notice → - 2026-06-10
- US
Intuitive Surgical, Inc. recalls Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product Description:…
Due to unintentionally activated near infrared handheld camera when attempting to turn off illumination during normal clinical workflow transitions, particularly when switching from the handheld camera to the robotic…
FDA · DeviceIntuitive Surgical, Inc.U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA,…Official notice → - 2026-05-13
- US
Intuitive Surgical, Inc. recalls Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06
Reloads for curved-tipped stapler may potentially produce an incomplete staple line.
FDA · DeviceIntuitive Surgical, Inc.US: Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware…Official notice → - 2026-04-08
- US
Intuitive 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 →
Other drugs & medical recalls in the United States
- 2026-05-13
- US
Spacelabs Healthcare, Inc. recalls Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Module Model/Catalog Number: 91496 Software Version: N/A…
Due to a manufacturing issue (i.e. malfunctioning of electrical Leakage tester).
FDA · DeviceSpacelabs Healthcare, Inc.Worldwide - US Nationwide di GA, KS, MI, OH, SC, TX, WA and the country of…Official notice → - US
Centinel Spine, Inc. recalls Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.
Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Large 5mm product was labeled as a 6mm.
FDA · DeviceCentinel Spine, Inc.US Nationwide distribution in the states of AZ, CA, GA, LA, MO, NY, TN, TX.Official notice → - US
Boston Scientific Corporation recalls LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5
For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhythmia and Pause (M312 only). In…
FDA · DeviceBoston Scientific CorporationWorldwide distribution - US Nationwide and the country of Belgium.Official notice → - US
Medical Action Industries, Inc. 306 recalls Medical Action Industries Inc. Pack Cath BHH, REF: BHCA49K, Sterile EO, Rx Only, QTY: 5/Case
Convenience kit contains a syringe in which the rotating adapter may unwind during use, resulting in a loose connection and/or full disconnection between the syringe and manifold"
FDA · DeviceMedical Action Industries, Inc. 306US distribution to state of: AZ OUS: NoneOfficial notice → - US
American Contract Systems Inc recalls Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor CORONARY ANGIO PACK Model numbers…
Impacted kits contain syringes recalled by Medline Industries. Syringe rotating adaptor may unwind during use, which may result in a loose connection or full disconnection between the syringe and manifold. Potential…
FDA · DeviceAmerican Contract Systems IncUS distribution to MN. No OUS distribution.Official notice → - US
AVID Medical, Inc. recalls Halyard CARDIAC CATH TRAY SHANDS JAX kit. Model Number: SHND401-04, SHND401-05.
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.