Gauze / Sponge,nonresorbable For External Use
General, Plastic Surgery · 21 CFR 878.4014
Recent MDR events
271 adverse event reports on file
- MEDLINEJul 13, 2026MalfunctionMedline Industries, Lp1417592-2026-05203
- MEDLINEJul 13, 2026MalfunctionMedline Industries, Lp1417592-2026-05452
- CURADJul 2, 2026MalfunctionMedline Industries, Lp1417592-2026-04046
- MEDLINEJun 30, 2026MalfunctionMedline Industries, Lp1417592-2026-03618
- MEDLINEJun 26, 2026MalfunctionMedline Industries, Lp1417592-2026-03398
- MEDLINEJun 4, 2026MalfunctionMedline Industries, Lp1417592-2026-02118
- PRIVATE LABELJun 1, 2026MalfunctionMedline Industries, Lp1417592-2026-01983
- MEDLINEMay 12, 2026MalfunctionMedline Industries, Lp1417592-2026-01212
- MEDLINEApr 7, 2026MalfunctionMedline Industries, Lp1417592-2026-00375
- EQUATEMar 4, 2026MalfunctionMedline Industries, Lp1417592-2026-00180
Event type breakdown
Recalls
6 recall events for this product code
- Revmedx IncTerminatedSep 11, 2015
XGAUZE Trauma Dressing, catalog number FIN-0002-01.
The XGAUZE Trauma Dressing was recalled because the packages may acquire small tears or pinholes during shipping due to use of shipping containers that lacked adequate protective materials. If present, these small tears or pinholes may disrupt package integrity and render the device unsterile.
Z-2762-2015 · View FDA record ↗ - Hartmann USA, IncTerminatedJun 22, 2012
Hartmann Econolux Ref 416 105 Sterile Gauze sponge 4"x4" 12-ply 24 boxes/case 1200 total sponges
Micro holes were detected in the laminate of the sterile barrier system of sterilized Hartmann Econolux and Hartmann Sterilux gauze products
Z-1857-2012 · View FDA record ↗ - Hartmann USA, IncTerminatedJun 22, 2012
Hartmann Sterilux Ref 56910000 Sterile Premium gauze sponge 4"x4" 12-ply 24 boxes/case 1200 total sponges
Micro holes were detected in the laminate of the sterile barrier system of sterilized Hartmann Econolux and Hartmann Sterilux gauze products
Z-1858-2012 · View FDA record ↗ - ASO, LLCOpen, ClassifiedUnknown
Family Wellness First Aid Sterile Gauze Pad 3 in x 3 in, 10 CT. White, bleached, non-woven, rayon/polyester sterile Gauze Pad 3 inch x 3 inch, 12-ply 10 co
Potential that gauze pads may not be fully sterilized
Z-0525-2019 · View FDA record ↗ - Medline Industries IncTerminatedUnknown
RevMedX Trauma Dressings are packaged in a Tyvek Peel pouch, 1 Trauma Dressing per Tyvec Peel Pouch, 30 Pouches per Case; Sterile - Product Usage: are intended
RevMedX Trauma Dressing is being recalled due to package seal integrity.
Z-0615-2021 · View FDA record ↗ - Cardinal Health 200, LLCTerminatedUnknown
Curity All Purpose Sponges, Non-woven, 4 Ply, 4" x 4" (10.2 cm x 10.2 cm)
Curity All Purpose Sponges were not sterilized and distributed
Z-0957-2019 · View FDA record ↗
Registered firms
600 firms currently registered for this product code
Aid United International Co., Limited
SHANGHAI, CN
Sterigenics Us Llc
Gurnee, IL, US
Gyrus Acmi, Inc.
Westborough, MA, US
Resorba Medical Gmbh
NUERNBERG Bavaria, DE
Yiwu Ori-power Medtech Co., Ltd.
YIWU Zhejiang, CN
Hubei Guarddent Medical Technology Co.,ltd
Wuhan Hubei, CN
Jingmen Huasheng Asia Dynamics Sanitary Products Co., Ltd.
Jingmen City Hubei, CN
Hangzhou Alline Plastic Co., Ltd.
HANGZHOU Zhejiang, CN
Wuhan Zonsen Medical Products Co., Ltd
Wuhan Hubei, CN
Suzhou Meccan Import And Export Corp.
Suzhou Jiangsu, CN
Guangzhou Huada Biotechnology Co., Ltd.
Guangzhou Guangdong, CN
Sterigenics Us Llc
Los Angeles, CA, US
Suzhou Hengxiang Imp. & Exp. Co., Ltd
SUZHOU Jiangsu, CN
Winner Medical (wuhan) Co., Ltd.
Wuhan Hubei, CN
Allmed Industrial Limited
Shenzhen City Guangdong, CN
Sprinkle Co., Ltd.
Yongin Gyeonggi, KR
United Technology Vietnam Company Limited
Quang Ha Commune Quang Ninh, VN
Weihai Xingtai Packaging Products Co., Ltd.
WeiHai Shandong, CN
Lohmann & Rauscher Gmbh
Schoenau an der Triesting Niederosterreich, AT
Z-medica, Llc
North Haven, CT, US
Bioseal
PLACENTIA, CA, US
Bong Bach Tuyet Joint Stock Company
Ho Chi Minh, VN
Hubei Xianbao Medical Health Products Co., Ltd.
XIANTAO CITY, HUBEI PROVINCE, CN
Yanling Medtech Medical Products Co., Ltd.
Xuchang Henan, CN
Hospital & Homecare Imp. & Exp. Co., Ltd
NANJING Jiangsu, CN
510(k) clearances
88 clearances for this product code
- IvalonFeb 27, 1995
K946015 · IVALON EXTERNAL SPONGE
- Isolyer Co.May 2, 1994
K940755 · ISOLYER (4X4, 8PLY)
- Omni Mfg., Inc.Jun 24, 1993
K931610 · OMNISORB II, NONWOVEN SPONGE, STERILE AND NON
- Gam Industries, Inc.Apr 8, 1993
K925590 · MULTI-TRAUMA DRESSING
- Parema , Ltd.Mar 19, 1993
K926072 · K-BAND AND K-CREPE
- Eagle Medical, Inc.Jan 27, 1993
K915591 · STERILE GAUZE PADS
- Dav-Mar Medical Products, Inc.Jan 11, 1993
K924650 · GAUZE SPONGES
- Winfield Laboratories, Inc.Dec 7, 1992
K923602 · ABSORBENT PAD -- MODIFICATION