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 4-Row 2.0 mm Xi|X REF 48230M INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm White 4-Row 2.5 mm Xi|X REF 48230W INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm Blue 4-Row 3.5 mm Xi|X REF 48230B

Class I - Dangerous

🏥 Medical Devices Recalled: October 7, 2022 Intuitive Surgical Infusion Pumps

What Should You Do?

Check if you have this product:
Model Name / Model Number / UDI-DI Code: Da Vinci Xi 8mm SureForm 30 instruments 488530-10 10886874121723 Da Vinci Xi 8mm SureForm 30 Grey Reload 48230M-02 10886874121938 Da Vinci Xi 8mm SureForm 30 White Reload 48230W-02 10886874121921 Da Vinci Xi 8mm SureForm 30 Blue Reload 48230B-02 10886874121914 All Serial Numbers
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Intuitive Surgical, Inc.
Reason for Recall:: Potential staple deployment failure and device fragment generation
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: ongoing

Product Information

Full Description:

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 4-Row 2.0 mm Xi|X REF 48230M INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm White 4-Row 2.5 mm Xi|X REF 48230W INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm Blue 4-Row 3.5 mm Xi|X REF 48230B

Product Codes/Lot Numbers:

Model Name / Model Number / UDI-DI Code: Da Vinci Xi 8mm SureForm 30 instruments 488530-10 10886874121723 Da Vinci Xi 8mm SureForm 30 Grey Reload 48230M-02 10886874121938 Da Vinci Xi 8mm SureForm 30 White Reload 48230W-02 10886874121921 Da Vinci Xi 8mm SureForm 30 Blue Reload 48230B-02 10886874121914 All Serial Numbers

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0340-2023

Related Recalls

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Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System Model/Catalog Number: IS4000; IS4200 Software Version: N/A Product Description: he da Vinci Xi, X Surgical systems each consist of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The PC is the operative component of the system, and its primary function is to support the instrument arms and camera arm. Each system have four Universal Surgical Manipulators (USMs) also known as arms, which allow the surgeon to control up to three instruments and an endoscope simultaneously to perform surgical tasks (e.g. cutting, suturing, tissue approximation) in a variety of procedures. As the surgeon moves the hand controls within the console, the PC moves the robotic instruments within the patient in a corresponding manner. The da Vinci system and its software are designed such that instruments motion precisely tracks the motion inputs from the hand controls during surgery. Component: The affected part based on this recall, 380647-xx, USM, is a sub component of da Vinci Surgical Instrument

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