Carefree Surgical Specialties recalls Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Ro…

Due to two issues: 1. Product contamination (biological foreign matter) that could compromise sterility. 2. Incorrect quantity of gauze in sterile packaging

On 07/9/2025 and 07/14/2025, the firm send via email and certified mail an "URGENT: MEDICAL DEVICE VOLUNTARY RECALL" Letter to customers informing them of two product issues: 1. the potential presence of foreign matter contamination within some units. 2. packaging discrepancy involving the number of gauze packs contained within sealed units. Customers are instructed to: For Issue 1: 1. Discontinue Use: Discontinue use of any unopened packages of SKU 15506/25 from Lots 1607. 2.Report any findings: Report any findings to Carefree Surgical using the contact information below. 3.Return or Dispose of Affected Product: "Customers may return affected product to Carefree Surgical Specialties, Inc. A shipping label will be provided upon request. "Or, if preferred, Customers may dispose of affected units per your facility s procedures and notify us for documentation and replacement coordination. 4.Do not use, resell, or further distribute affected product. For Issue 2: 1.Inspect their inventory: Visually check all unopened packages of SKU 15508/25 from Lots 1595 and SKU 15505/25 from Lots 1645 and 1650 to confirm each contains five (5) sterile gauze rolls 2.Report any discrepancies: If any units contain more than 5 rolls, please notify us immediately using the contact information below. 3.Return or Dispose of Affected Product: "Customers may return affected product to Carefree Surgical Specialties, Inc. A shipping label will be provided upon request. "Or, if preferred, Customers may dispose of affected units per your facility s procedures and notify us for documentation and replacement coordination. 4.Do not use, resell, or further distribute affected product. Any questions or need assistance with returns or replacements, please contact: Attn: Sarah Monroe Carefree Surgical Specialties, Inc. (916)663-4082 or support@carefreesurgical.com

• FDA enforcement recordOfficial FDA database entry for Z-2283-2025
• FDA 510(k) clearance · K882708The device's official FDA premarket clearance record
• FDA device classification · GDYOfficial FDA classification for this device type
• CFR regulation · 21 CFR 878.4450The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Carefree Surgical SpecialtiesSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.