Kittner and tail gauze rolls had biological foreign matter inside packaging
Carefree Surgical Specialties Kittner + Tail Large roll gauzes are being recalled for product contamination with biological foreign matter that could compromise sterility, and an incorrect quantity of gauze in sterile packaging.
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: Risk-of-harm product: biological foreign matter that could compromise sterility on gauze used inside the surgical field, with no infection reported.
Plain-English summary
Carefree Surgical Specialties Robotic/Laparoscopy Kittner + Tail Large roll gauzes, 4 inches long, x-ray detectable, 5 per pack, 25 packs per case, catalog number 15508/25, is being recalled. The action covers 20 units from lot 1595.
The stated reason covers 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. The source does not report any infection having occurred.
Distribution was nationwide in the United States, including Kentucky, Texas, Florida, North Carolina, Colorado, California, Idaho, West Virginia and New York. The gauze is supplied to surgical facilities rather than sold to consumers.
Facilities should identify affected stock using the catalog number and lot number above, quarantine it, and follow the instructions issued by the manufacturer.
The recalled product
- Product
- Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner + Tail Large 4 Long X-Ray Detectable 5pk 25pk/CS Roll Gauzes Model/Catalog Number: 15508/25 Product Description: Robotic/Laparoscopy Kittner + Tail Large 4 Long X-Ray Detectable 5pk 25pk/CS R
- Manufacturer
- Carefree Surgical Specialties
- Category
- Medical Device — Surgical gauze
- Hazard
- biological-foreign-matter
- sterility-compromise
- 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: 1595 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