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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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…
- Manufacturer
- Carefree Surgical Specialties
- Affected units
- 500
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
Part of a larger recall action
This product is one of 4 recalled by Carefree Surgical Specialties under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · Carefree Surgical Specialties
See all →- HighKittner and tail gauze rolls had biological foreign matter inside packaging
FDA (Devices) · 2025-08-20
- HighKittner gauze rolls had biological foreign matter and wrong pack quantity
FDA (Devices) · 2025-08-20
- HighKittner roll gauze with tail recalled over contamination and incorrect pack quantity
FDA (Devices) · 2025-08-20
Same hazard · sterility compromise
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