FDA recall Z-2283-2025

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

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

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.

Key facts

Status

Ongoing

Initiation date

2025-07-01

Report date

2025-08-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Nampa, ID, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2283-2025