Gauze/Sponge, Internal, X-Ray Detectable

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2026-07-10Open, ClassifiedMaterial/Component Contamination

  Arterial Line Kit 20ga x 6, REF: 400115A

  Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.

• 2025-08-08Open, ClassifiedProcess control

  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 Roll Gauzes

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

• 2025-08-08Open, ClassifiedProcess control

  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/CS

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

• 2025-08-08Open, ClassifiedProcess control

  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/CS

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

• 2025-08-08Open, ClassifiedProcess control

  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 Detectable 5pk 25pk/CS Roll Gauzes

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

• 2024-03-21Open, ClassifiedLabeling mix-ups

  Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1

  Packs including 5 laparotomy sponges may contain incorrect product with a blue loop, X-ray detectable feature, and ethylene oxide treatment; however, this incorrect product wasn't steam pre-treated prior to sterilization, and has no RF tag, which if non-sterile, may lead to infection, tissue trauma, and sepsis, and if in the scannable area, would lead a "CLEAR" display.

• 2012-05-10TerminatedProcess control

  8" x 4" 16-ply X-Ray Gauze, hospital fold, banded in 10's; 200 pieces per bag, 10 bags per case; Distributed By: International Medsurg Connection, Schaumburg, IL USA 1-847-619-9926; Made in China; item IMSGZX8416-10 For use to control bleeding and absorb fluid.

  The lots of X-Ray Gauze are contaminated with foreign material, including remnants of cotton seeds and lint.

• 2012-05-10TerminatedProcess control

  8" x 4" 16-ply Dual X-Ray Gauze, hospital fold, banded in 10's; 200 pieces per bag, 10 bags per case; Distributed By: International Medsurg Connection, Schaumburg, IL USA 1-847-619-9926; Made in China; item IMSGZXX8416-10 For use to control bleeding and absorb fluid.

  The lots of X-Ray Gauze are contaminated with foreign material, including remnants of cotton seeds and lint.

• 2010-06-02TerminatedPackage design/selection

  ARTERIAL LINE KIT Arterial Line Kit #2 20ga X 3" REF/REORDER NO. 194284 Labeled Sterile, Rx. Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751 800-927-4669.

  There are 1-2 places on some of the multi-purpose kit blisters/trays in which there are holes and/or the material is so thin that holes are easily created. This would potentially cause the sterility of the products to be compromised.

• 2010-06-02TerminatedPackage design/selection

  ARTERIAL LINE KIT REF/REORDER NO. 498104 DISPOSABLE SINGLE USE, Rx. Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751.

  There are 1-2 places on some of the multi-purpose kit blisters/trays in which there are holes and/or the material is so thin that holes are easily created. This would potentially cause the sterility of the products to be compromised.