Gauze/sponge, Internal, X-ray Detectable
General, Plastic Surgery · 21 CFR 878.4450
Recent MDR events
2,521 adverse event reports on file
- VISTECJul 31, 2026MalfunctionCardinal Health 200, Llc1423537-2026-00251
- SurgiCount+ Gauze, 4x4 16 Ply, RFID, Double XRAYJul 29, 2026InjuryStryker Instruments-a Division Of Stryker Corp3015967359-2026-00451
- Arterial Catheter Mini-Kit 20ga x 6"Jul 29, 2026InjuryArgon Medical Devices, Inc0001625425-2026-00998
- VISTECJul 28, 2026MalfunctionCardinal Health 200, Llc1423537-2026-00246
- SURGICOUNT+ GAUZE, 8X4, 12 PLY, RFID, DOUBLE XRAYJul 22, 2026MalfunctionStryker Instruments-a Division Of Stryker Corp3015967359-2026-99356
- GZ SPNG, 4X4, 16P, DX, BULKJul 22, 2026MalfunctionStryker Instruments-a Division Of Stryker Corp3015967359-2026-99389
- UNKNOWN LAP SPONGEJul 13, 2026MalfunctionCovidien3026612481-2026-00043
- SITUATEJul 6, 2026MalfunctionCovidien3026612481-2026-00038
- UNKNOWN LAP SPONGEJul 6, 2026InjuryCovidien3026612481-2026-00039
- VISTECJul 6, 2026MalfunctionCardinal Health 200, Llc1423537-2026-00217
Event type breakdown
Recalls
66 recall events for this product code
- Argon Medical Devices, IncOpen, ClassifiedJul 10, 2026
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.
Z-2708-2026 · View FDA record ↗ - Carefree Surgical SpecialtiesOpen, ClassifiedAug 8, 2025
Brand Name: Carefree Surgical Specialties
Due to two issues: 1. Product contamination (biological foreign matter) that could compromise sterility. 2. Incorrect quantity of gauze in sterile packaging
Z-2281-2025 · View FDA record ↗ - Carefree Surgical SpecialtiesOpen, ClassifiedAug 8, 2025
Brand Name: Carefree Surgical Specialties
Due to two issues: 1. Product contamination (biological foreign matter) that could compromise sterility. 2. Incorrect quantity of gauze in sterile packaging
Z-2282-2025 · View FDA record ↗ - Carefree Surgical SpecialtiesOpen, ClassifiedAug 8, 2025
Brand Name: Carefree Surgical Specialties
Due to two issues: 1. Product contamination (biological foreign matter) that could compromise sterility. 2. Incorrect quantity of gauze in sterile packaging
Z-2283-2025 · View FDA record ↗ - Carefree Surgical SpecialtiesOpen, ClassifiedAug 8, 2025
Brand Name: Carefree Surgical Specialties
Due to two issues: 1. Product contamination (biological foreign matter) that could compromise sterility. 2. Incorrect quantity of gauze in sterile packaging
Z-2284-2025 · View FDA record ↗ - CovidienOpen, ClassifiedMar 21, 2024
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.
Z-1330-2024 · View FDA record ↗ - International Medsurg Connection, Inc.TerminatedMay 10, 2012
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, I
The lots of X-Ray Gauze are contaminated with foreign material, including remnants of cotton seeds and lint.
Z-1517-2012 · View FDA record ↗ - International Medsurg Connection, Inc.TerminatedMay 10, 2012
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, Schaumbu
The lots of X-Ray Gauze are contaminated with foreign material, including remnants of cotton seeds and lint.
Z-1518-2012 · View FDA record ↗ - Argon Medical Devices, IncTerminatedJun 2, 2010
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
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.
Z-1737-2010 · View FDA record ↗ - Argon Medical Devices, IncTerminatedJun 2, 2010
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.
Z-1740-2010 · View FDA record ↗
Registered firms
240 firms currently registered for this product code
Cenefom Corp
Zhunan Township Miaoli, TW
Anqing Clean Dental Instrument Technology Co.,ltd
Anqing City Anhui, CN
Saint Jones Management Lp Eood
Sofia Sofia-Grad, BG
J Sterling Industries Llc
Kalamazoo, MI, US
Steris Ast Cz S.r.o.
VELKA BITES Vysocina, CZ
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
Isomedix Operations Inc.
CHESTER, NY, US
Mcneil Healthcare Llc
Fairfield, NJ, US
Bestreat Safety & First Aid Solution Co., Ltd
Wuhan Hubei, CN
Steris Corporation
MONTGOMERY, AL, US
Bluepoint Laboratories
Cork Munster, IE
An Lanh Investment And Trading Company Limited
Thanh Nam Ward Ninh Binh, VN
Hospital & Homecare Imp. & Exp. Co., Ltd
NANJING Jiangsu, CN
Oketz Logistics Llc
Coral Gables, FL, US
Isomedix Operations Inc.
S Plainfield, NJ, US
Allmed Medical Products Co., Ltd.
ZHIJIANG CITY Hubei, CN
Suzhou Avon Textile Co., Ltd.
Suzhou City Jiangsu, CN
Shanghai Alwings Medical Instrument Co.,ltd.
Shanghai, CN
Allmed Industrial Limited
Shenzhen City Guangdong, CN
Young Innovations Inc.
Algonquin, IL, US
Parter Medical Products, Inc.
CARSON, CA, US
Teleflex Llc (nadc)
Olive Branch, MS, US
Gauke (hubei) Healthcare Co., Ltd
Huanggang City Hubei, CN
Nantong Michael Irradiation Co., Ltd.
Nantong Jiangsu, CN
Xiantao S&j Protective Products Co., Ltd
Xiantao Hubei, CN
510(k) clearances
111 clearances for this product code
- Ultracell Medical Technologies, Inc.Dec 17, 1997
K972634 · ULTRACELL SUCTION SPONGE
- Custom Pack ReliabilityMar 28, 1996
K960236 · CPR LAP SPONGES
- Stryker Corp.Feb 22, 1996
K955599 · STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGE
- Derivados DE Gasa, S.A. DE C.V.Dec 19, 1995
K955322 · PROTEC X-RAY DETECTABLE GAUZE SPONGE
- Kentron Health Care, Inc.Oct 3, 1995
K953830 · KENSORB
- Medical Perspectives Corp.Sep 14, 1995
K953060 · ROSEBUD DISSECTOR
- Medical Perspectives Corp.Sep 14, 1995
K953087 · CHERRY PIT DISSECTOR
- Medical Perspectives Corp.Sep 14, 1995
K953057 · CYLINDRICAL SPONGE