🔍 RecallPedia

daVinci XI Sureform 60 reload, 60 mm Green 6- Row, 4.6 mm, REF 48360G-08, UDI: 00886874113844, Rx Only, Sterile EO - Product Usage: are intended to be used with da Vinci Surgical Systems for resection, transection, and, or creation of anastomoses in General, Thoracic, Gynecologic, Urologic, and Pediatric surgery.

Class I - Dangerous
🏥 Medical Devices Recalled: July 1, 2019 Intuitive Surgical Surgical Instruments Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot numbers: T10180511; T10180718; T10180821;T10180822; T10180906; T10180913; T10180925; T10181008; T10190204; T10190208; T10190213; T11180816; T11190219
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. 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:
The firm became aware of a manufacturing variation in which black and green reloads in select Stapler Reloads may not deploy individual adjacent staples, which could result in an incomplete staple line. Failure of a incomplete staple like could potentially lead to an air leak or an anastomotic leak which may require an additional procedural intervention.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

daVinci XI Sureform 60 reload, 60 mm Green 6- Row, 4.6 mm, REF 48360G-08, UDI: 00886874113844, Rx Only, Sterile EO - Product Usage: are intended to be used with da Vinci Surgical Systems for resection, transection, and, or creation of anastomoses in General, Thoracic, Gynecologic, Urologic, and Pediatric surgery.

Product Codes/Lot Numbers:

Lot numbers: T10180511; T10180718; T10180821;T10180822; T10180906; T10180913; T10180925; T10181008; T10190204; T10190208; T10190213; T11180816; T11190219

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1890-2020

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