The Recall Desk

FDA (Devices) recall action 97259

Carefree Surgical Specialties recalled 4 products on 2025-08-20

The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.

Products
4
Announced
2025-08-20
Critical
0
Units
1,085

Why these products were recalled

Due to two issues: 1. Product contamination (biological foreign matter) that could compromise sterility. 2. Incorrect quantity of gauze in sterile packaging

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–4 of 4

  • HighFDA (Devices)··2025-08-20

    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.

    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/
    Category
    Distribution
    39 states
  • HighFDA (Devices)··2025-08-20

    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.

    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
    Category
    Distribution
    39 states
  • HighFDA (Devices)··2025-08-20

    Kittner gauze rolls had biological foreign matter and wrong pack quantity

    Carefree Surgical Specialties Robotic/Laparoscopy Kittner Rolls Gauze is being recalled for product contamination with biological foreign matter that could compromise sterility, and an incorrect quantity of gauze in sterile packaging.

    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/
    Category
    Distribution
    39 states
  • HighFDA (Devices)··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.

    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
    Category
    Distribution
    39 states