Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The da Vinci Xi and X surgical systems (IS4000 and Recalled by Intuitive Surgical, Inc. Due to Incorrect expiration date on its package labeling (shipper...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Intuitive Surgical, Inc. directly.
Affected Products
The da Vinci Xi and X surgical systems (IS4000 and IS4200) each consist of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The Patient Cart is the operative component of the system and its primary function is to support the instrument arms and camera arm. The X/Xi Instrument Arm Drape is intended to be used with the instrument arms of the PC as a sterile barrier during clinical procedures, and makes the instrument arms sterile and suitable for surgery. X/Xi Instrument Arm Drapes are sterile unless the package is opened or damaged, and are indicated for a single use. The drapes are placed onto the instrument arms by two users (one sterile and one non-sterile)in tandem, with the non-sterile user leading the placement via drape cuff pockets.
Quantity: 1,740 drapes (87 bobes)
Why Was This Recalled?
Incorrect expiration date on its package labeling (shipper box and inner carton label).
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Intuitive Surgical, Inc.
Intuitive Surgical, Inc. has 244 total recalls tracked by RecallDetector.
Related Recalls
EndoVive Safety PEG Kit Recalled by Boston Scientific Corporation Due to Recall of kits which utilized ChloraPrep Triple Swabsticks...
Boston Scientific Corporation · February 10, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Artelon FlexBand Dynamic Matrix Ref: 31057 Recalled by International Life Sciences Due to Augmentation devices failed bacterial endotoxin testing.
International Life Sciences · February 6, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Data sourced from the FDA (Device). Last updated March 26, 2026. View original report