FDA Medical devices recall ·
Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner… recall
- Recall number
- Z-2283-2025
- Date
- (initiated July 1, 2025)
- Company / brand
- Carefree Surgical Specialties
1123 12th Avenue, Nampa, ID, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 500
- Hazard tags
- Foreign material Sterility Microbial contamination
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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
Why was it recalled?
Due to two issues: 1. Product contamination (biological foreign matter) that could compromise sterility. 2. Incorrect quantity of gauze in sterile packaging
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot Code: Lot Number: 1650 UDI Code: Not Available
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.
States: Alabama Arkansas Arizona California Colorado Connecticut Florida Georgia Iowa Idaho Illinois Indiana Kentucky Louisiana Massachusetts Maryland Michigan Minnesota Missouri Montana North Carolina Nebraska New Hampshire New Jersey Nevada New York Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina Tennessee Texas Virginia Vermont Washington Wisconsin West Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2283-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.