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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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High RiskFDA Device
Medical Devices/Surgical Equipment

Intuitive Surgical, Inc.: da Vinci SP Surgical Patient Cart Recalled Due to Weak Belt Welds

Agency Publication Date: April 11, 2024
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Summary

Intuitive Surgical, Inc. is recalling 53 units of the Patient Cart (Part 380601), which is a key component of the da Vinci SP Surgical System (Model SP1098). The recall was initiated because certain joints in the surgical instrument arms may have inadequately welded belts. If these belts fail, it could result in internal tissue injuries to the patient, body wall injuries, or the need to suddenly switch to a traditional open surgery. In some cases, the defect could also cause a pinching injury to the surgical staff, though no patient harm has been reported from that specific type of failure. Patients and providers should contact the manufacturer regarding the affected serial numbers, which include SP0202 through SP0282.

Risk

The inadequately welded belts in the instrument arm joints can break during surgery, leading to unintended movement of the surgical tools inside the patient or mechanical failure that forces an emergency conversion to open surgery. This poses a risk of internal organ damage, tissue injury, or physical injury to the medical staff operating the system.

What You Should Do

  1. Identify if your facility uses the da Vinci SP Surgical System, specifically the Patient Cart component (Part: 380601, Model: SP1098).
  2. Check the serial number on the Patient Cart to see if it matches any of the 53 affected units: SP0202, SP0253, SP0254, SP0219, SP0228, SP0231, SP0238, SP0273, SP0208, SP0226, SP0240, SP0247, SP0249, SP0256, SP0257, SP0268, SP0270, SP0272, SP0221, SP0223, SP0225, SP0229, SP0230, SP0232, SP0233, SP0235, SP0236, SP0237, SP0239, SP0241, SP0242, SP0243, SP0244, SP0245, SP0248, SP0250, SP0251, SP0252, SP0255, SP0258, SP0259, SP0260, SP0261, SP0262, SP0263, SP0264, SP0265, SP0266, SP0269, SP0274, SP0278, SP0280, SP0282.
  3. If you have an affected unit, contact Intuitive Surgical, Inc. immediately to arrange for inspection or repair of the entry guide manipulator assembly and instrument arm joints.
  4. Healthcare providers should monitor for any mechanical irregularities during surgical procedures and contact the manufacturer for further instructions or potential refund queries.
  5. For additional information or questions, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer notification and potential repair/inspection.

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Patient Cart (component of da Vinci SP Surgical System)
Model / REF:
SP1098
Part: 380601
UPC Codes:
00886874114605
Lot Numbers (53):
SP0202
SP0253
SP0254
SP0219
SP0228
SP0231
SP0238
SP0273
SP0208
SP0226
SP0240
SP0247
SP0249
SP0256
SP0257
SP0268
SP0270
SP0272
SP0221
SP0223
SP0225
SP0229
SP0230
SP0232
SP0233
SP0235
SP0236
SP0237
SP0239
SP0241
SP0242
SP0243
SP0244
SP0245
SP0248
SP0250
SP0251
SP0252
SP0255
SP0258
SP0259
SP0260
SP0261
SP0262
SP0263
SP0264
SP0265
SP0266
SP0269
SP0274

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94252
Status: Active
Manufacturer: Intuitive Surgical, Inc.
Sold By: Intuitive Surgical, Inc.; Hospital suppliers
Manufactured In: United States
Units Affected: 53
Distributed To: Virginia, California, New Hampshire, Florida, New York, Colorado, Alabama, Kentucky, Maryland, North Carolina, New Jersey, Ohio, South Carolina, South Dakota, Tennessee, Washington, Wisconsin, West Virginia, Mississippi, Texas, Kansas

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.