Drugs & medicalClass II

Intuitive Surgical, Inc. recalls Da Vinci S/Si Large Clip Applier, Model 420230 Da Vinci S/Si Medium-Large Clip Applier, Model 420327 Da Vinci S/Si Small Clip Applier,…

Due to the potential for unexpected motion caused by the partial disengagement of the instrument from the system.

Read the official notice →
Date
2022-08-03
Country
United States
Brand
Intuitive Surgical
Product
Da Vinci S/Si Large Clip Applier, Model 420230 Da Vinci S/Si Medium-Large Clip Applier, Model 420327 Da Vinci S/Si Small Clip Applier,…
Classification
Class II
Units
Worldwide distribution - U.S. Nationwide distribution in the states of AL, AK,…
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 Details may be shortened or out of date; the official notice is the authoritative source.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

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. 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

  1. 2022-12-07
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    Intuitive Surgical, Inc. recalls INTUITIVE Da Vinci Xi 8mm SureForm 30 Curved-Tip Stapler Da Vinci Xi|X REF 488530 INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm Gray…

    Potential staple deployment failure and device fragment generation

    FDA · DeviceIntuitive Surgical, Inc.U.S.: Arizona, California, Colorado, Florida, Illinois, Indiana, Louisiana,…Official notice →
  3. 2022-11-02
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    Intuitive Surgical, Inc. recalls da Vinci X (IS4200) and Xi (IS4000) systems, which consists of finished devices Surgeon Console (SSC), Patient Cart (PSCART), Vision…

    Inadvertent energy delivery from surgical system instrument if 1) Force bipolar and bipolar instruments installed on system 2) Force bipolar connected to Force Triad generator, bipolar not connected to generator 3)…

    FDA · DeviceIntuitive Surgical, Inc.US: MS, PA, WI, KY, TN, MI, FL, GA, NC, NV, LA, OH, IL, MO, IN, CA, AK, MD,…Official notice →
  5. 2022-08-10
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    Intuitive Surgical, Inc. recalls The E-100 Generator (PN 374848-09) is a bipolar electrosurgical unit (ESU) designed to be used with the da Vinci Xi and X systems. The…

    Due to preventative maintenance (PM) not being performed on E-100 generators which is a bipolar electrosugical unit designed to be used with the da Vinci Xi and X systems.

    FDA · DeviceIntuitive Surgical, Inc.Worldwide distribution - U.S. Nationwide distribution in the states of AL, AK,…Official notice →
  7. 2022-06-08
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    Intuitive Surgical, Inc. recalls VESSEL SEALER EXTEND, Single-Use Instrument EndoWrist Instruments 8mm, da Vinci X' da Vinci Xi', REF 480422

    Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal.

    FDA · DeviceIntuitive Surgical, Inc.Worldwide distribution - US Nationwide and the countries/regions of Argentina,…Official notice →
  9. 2022-05-04
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    Intuitive Surgical, Inc. recalls da Vinici X da Vinci Xi Sureform 45 REF 480445 da Vinci X da Vinci Xi Sureform 45 Curved-Tip REF 480545 da Vinici X da Vinci Xi Sureform…

    As a result of complaint data review, it identified tissue pushout events occurring during firing of the SureForm stapler when tissue is pushed distally within the jaws, rather than being held in place and transected.…

    FDA · DeviceIntuitive Surgical, Inc.Worldwide distribution - U.S. Nationwide distribution in the states of AL, AK,…Official notice →
  11. 2022-03-09
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    Intuitive Surgical, Inc. recalls da Vinci Xi and X 12-8 mm Conductive Cannula Reducer, REF: 470381-11

    Conductive Cannula Reducer metal tip may get dislodged from the plastic shaft. If unnoticed, additional surgery may be required to remove the metal tip. If the procedure proceeds without the metal tip, there is…

    FDA · DeviceIntuitive Surgical, Inc.Worldwide distribution - US Nationwide distribution in the states of…Official notice →
All 32 Intuitive Surgical recalls →

Other drugs & medical recalls in the United States

  1. 2022-08-03
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    Fresenius Medical Care Holdings, Inc. recalls AquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic Part Number: G02000966-US

    Internal ethernet cable may be misaligned, the cable jacket (insulation) could become compromised due to high temperature and result in the internal ethernet cable conducting electrical current to the ethernet port on…

    FDA · DeviceFresenius Medical Care Holdings, Inc.US Nationwide distribution.Official notice →
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    NordicNeuroLab AS recalls nordicBrainEX, software versions 2.21 through 2.3.10

    When exporting merged results from the BOLD, DSC, and DCE modules of nordicBrainEx, where both the underlay and overlay originated from a multiframe dataset, the resulting output may have left/right sides flipped.

    FDA · DeviceNordicNeuroLab ASUS Nationwide distribution.Official notice →
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    Touch US Llc recalls etouchus, model no. ETM-G01. Noninvasive Blood glucose meter.

    Device was marketed without FDA 510(k) clearance or a PMA.

    FDA · DeviceTouch US LlcUS Nationwide Distribution to: CA, FL IL KY LA MA MD MI NC NH NJ NY OH OK OR…Official notice →
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    Paragon 28, Inc. recalls Paragon 28, Inc. System: Baby Gorilla/Gorilla Plating System, Ref: P99-100-2816, Material: Stainless Steel; Desc: Drill, 2.4 X 160mm

    Incorrect labeling; There is potential that the drill packaging contains the incorrect part number.

    FDA · DeviceParagon 28, Inc.International distribution in the country of UK.Official notice →
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    Davol, Inc. recalls X-Stream Irrigation System (Catalog No. 5551000) and X-Stream Irrigation System Refurbished (Catalog No. 9551000)

    The device may potentially cause a fire, leading to a safety risk.

    FDA · DeviceDavol, Inc.Worldwide distribution - US Nationwide and the countries of Canada and Chile.Official notice →
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    Abbott Laboratories recalls REF: 08P4377, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3 mL, A1cDL 5 x 67.6 mL

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