daVinci XI Sureform 60 Reload, 60 mm black 6-Row 4.6 mm, Ref: 48360T-08 , UDI: 00886874113851, Rx only, SterileEO - 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 - DangerousWhat Should You Do?
- Check if you have this product: Lot numbers: T10180615; T10180924; T10181003; T11181003; T10181010; T10181016; T10181029; T10181107; T10181109; T10181113
- 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:
- 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 black 6-Row 4.6 mm, Ref: 48360T-08 , UDI: 00886874113851, Rx only, SterileEO - 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: T10180615; T10180924; T10181003; T11181003; T10181010; T10181016; T10181029; T10181107; T10181109; T10181113
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1891-2020
Related Recalls
Due to an increase in complaints concerning foot tray pedal spring failing resulting in the pedal remaining pressed
8MM,HORIZON SMALL CLIP APPLIER,IS4000¿ REF 470401
Intuitive Surgical
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
8MM,MEGA SUTURECUT ND,IS4000 REF 471309
Intuitive Surgical
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.