Surgical gauze rolls recalled over biological foreign matter and miscounted packs
Carefree Surgical Specialties Robotic/Laparoscopy Kittner Rolls Gauze, catalog 15505/25 lot 1645, is recalled for biological foreign matter that could compromise sterility and for incorrect gauze counts. 500 units are affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; compromised sterility on a surgical product is a potential harm and no injuries are reported.
Plain-English summary
Carefree Surgical Specialties Robotic/Laparoscopy Kittner Rolls Gauze Medium, 4 inches long and X-ray detectable, supplied 5 per pack and 25 packs per case, model and catalog number 15505/25, is being recalled. The affected product carries lot number 1645. The recall covers 500 units distributed in Kentucky, Texas, Florida, North Carolina, Colorado, California, Idaho, West Virginia, New York, Illinois, Indiana, Iowa, Michigan, Louisiana, Wisconsin, Montana and Virginia.
The recall was issued for two issues: product contamination with biological foreign matter that could compromise sterility, and an incorrect quantity of gauze in the sterile packaging. The FDA classified the action as Class II.
Hospitals and surgical centres holding this lot should quarantine it and follow the manufacturer's instructions for return or replacement.
The recalled product
- 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/
- Manufacturer
- Carefree Surgical Specialties
- Hazard
- sterility-compromise
- foreign-matter
- incorrect-quantity
- class-ii
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Code: Lot Number: 1645 UDI Code: Not Available
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighOlympus Toomey Evacuator 50cc with Adaptor sterilization recall
FDA (Devices) · 2026-07-22
- SevereT-Lok Bone Marrow Tray Kits Recalled for Sterility Testing Failure
FDA (Devices) · 2026-07-22
- HighOlympus Glass Body for 194 Ellik Evacuator Model 190A Sterilization Recall
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella CP Introducer Kit heart pump accessory recall
FDA (Devices) · 2026-07-22
- SevereMedtronic Bio-Medicus Adult Cannula Kit Recalled for Foreign Material
FDA (Devices) · 2026-07-22