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…
Read the official notice →- Date
- 2026-07-01
- Country
- United States
- Brand
- Intuitive Surgical
- Product
- Da Vinci ASSY, PSS, SP1098, Part Number: 380601
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution including in the states of CA, GA, OH,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
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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 →- 2026-06-10
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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 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.
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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.
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Other drugs & medical recalls in the United States
- 2026-07-01
- US
Ventec Life Systems, Inc. recalls VOCSN+Pro package, REF: PRT-00853-000; VOCSN+Pro unit, REF: PRT-00490-001
Respiratory system intended to provide continuous/intermittent ventilator support, may have a damaged back-up battery supporting backup alarm function, which may result in the backup alarm not activating during loss of…
FDA · DeviceVentec Life Systems, Inc.US Nationwide distribution in the state of UT.Official notice → - US
TMJ Solutions Inc recalls TMJ Bilateral Implants, REF: CHG020
Custom temporomandibular joint implant may have contained incorrect patient-specific components that led to a poor fit of the implant, leading to a right-sided open bite.
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Philips North America Llc recalls Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A
Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker output.
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The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality issues identified…
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SUN PHARMACEUTICAL INDUSTRIES INC recalls Perampanel CIII Tablets, 6mg, Rx only, 30 Tablets, Mfd.by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761,…
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