Robotic/Laparoscopy Kit (Carefree Surgical) – Sterility Compromise (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner + Tail Large 4 Long X-Ray Detectable 5pk 25pk/CS Roll Gauzes Model/Catalog Number: 15508/25 Product Description: Robotic/Laparoscopy Kittner + Tail Large 4 Long X-Ray Detectable 5pk 25pk/CS Roll Gauzes
Brand
Carefree Surgical Specialties
Lot Codes / Batch Numbers
Lot Code: Lot Number: 1595 UDI Code: Not Available
Products Sold
Lot Code: Lot Number: 1595 UDI Code: Not Available
Carefree Surgical Specialties is recalling Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner + Tail Large 4 due to Due to two issues: 1. Product contamination (biological foreign matter) that could compromise sterility. 2. Incorrect quantity of gauze in sterile p. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to two issues: 1. Product contamination (biological foreign matter) that could compromise sterility. 2. Incorrect quantity of gauze in sterile packaging
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026