Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Roll Gauze + Tail Medium 4 Long X-
Summary
The FDA issued a Class II for Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kit by Carefree Surgical Specialties. Reason: Due to two issues: 1. Product contamination (biological foreign matter) that could compromise sterility. 2. Incorrect quantity of gauze in sterile p.
Details
Source
Device Recall
External ID
Z-2284-2025
Action Date
2025-08-20
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: Lot Code: Lot Number: 1607 UDI Code: Not Available
Quantity Affected: 65
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-07-01
Company
Nampa, ID
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 169 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Carefree Surgical Specialties has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Carefree Surgical Specialties) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Carefree Surgical Specialties have FDA actions?
Carefree Surgical Specialties has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2284-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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