Class 2 Device Recall Carefree Surgical Specialties

• Date Initiated by Firm: July 01, 2025
• Date Posted: August 08, 2025
• Recall Status: Open, Classified
• Recall Number: Z-2284-2025
• Recall Event ID: 97259
• 510(K)Number: K882708
• Product Classification: Gauze/sponge, internal, x-ray detectable - Product Code GDY
• Product: Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Roll Gauze + Tail Medium 4 Long X-Ray Detectable 5pk 25pk/CS Roll Gauzes Model/Catalog Number: 15506/25 Product Description: Robotic/Laparoscopy Kittner Roll Gauze + Tail Medium 4 Long X-Ray Detectable 5pk 25pk/CS Roll Gauzes
• Code Information: Lot Code: Lot Number: 1607 UDI Code: Not Available
• Recalling Firm/ Manufacturer: Carefree Surgical Specialties; 1123 12th Avenue; Suite 341; Nampa ID 83686
• For Additional Information Contact: Sarah Monroe; 702-434-5058
• Manufacturer Reason for Recall: Due to two issues: 1. Product contamination (biological foreign matter) that could compromise sterility. 2. Incorrect quantity of gauze in sterile packaging
• FDA Determined Cause: Process control
• Action: 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
• Quantity in Commerce: 65
• Distribution: US Nationwide distribution in the states of KY, TX, FL, NC, CO, CA, ID, WV, NY, IL, IN, IA, MI, LA, WI, MT, VA, MA, TN, CT, AL, PA, MO, NJ, AR, OH, NE, AZ, MN, MD, GA, NC, WA, VT, OK, RI, SC, NH, VT, NV, OR.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = GDY