Agency classClass IIOur severity:High FDA (Devices)·Z-2284-2025·Announced 2025-08-20

Kittner roll gauze with tail recalled over contamination and incorrect pack quantity

Carefree Surgical Specialties Kittner Roll Gauze + Tail, catalog 15506/25 lot 1607, is recalled for biological foreign matter that could compromise sterility and for incorrect gauze counts. 65 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 Roll Gauze + Tail Medium, 4 inches long and X-ray detectable, supplied 5 per pack and 25 packs per case, model and catalog number 15506/25, is being recalled. The affected product carries lot number 1607. The recall covers 65 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 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…
Manufacturer: Carefree Surgical Specialties
Category: Medical Device — Surgical Supplies
Hazard: sterility-compromise
foreign-matter
incorrect-quantity
class-ii
Affected units: 65

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: 1607 UDI Code: Not Available

Distribution

Distributed nationwide across the United States.

The notice also names 39 states specifically:

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 →

Same manufacturer · Carefree Surgical Specialties

See all →

High
Surgical gauze rolls recalled over biological foreign matter and miscounted packs
FDA (Devices) · 2025-08-20
High
Kittner and tail gauze rolls had biological foreign matter inside packaging
FDA (Devices) · 2025-08-20
High
Kittner gauze rolls had biological foreign matter and wrong pack quantity
FDA (Devices) · 2025-08-20

Same hazard · sterility compromise