Carefree Surgical Specialties: Device Recall

Recall #Z-2283-2025 · 07/01/2025

Class II: Risk

Recall Details

Recall Number
Z-2283-2025
Classification
Class II
Product Type
Device
Recalling Firm
Carefree Surgical Specialties
Status
Ongoing
Date Initiated
07/01/2025
Location
Nampa, ID, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
500

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

Product Description

Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long X-Ray Detectable 5/pk 25pk/CS Model/Catalog Number: 15505/25 Product Description: Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long X-Ray Detectable 5/pk 25pk/CS

Distribution Pattern

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.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.