Dressing, Wound, Occlusive
General, Plastic Surgery · 21 CFR 878.4020
Recent MDR events
15,775 adverse event reports on file
- DUODERMJul 31, 2026MalfunctionConvatec Dominican Republic Inc9618003-2026-01213
- EquateJul 29, 2026InjuryEuromed, Inc.1038758-2026-00016
- DUODERMJul 28, 2026MalfunctionConvatec Dominican Republic Inc9618003-2026-01622
- DUODERMJul 28, 2026MalfunctionConvatec Dominican Republic Inc9618003-2026-01623
- DUODERMJul 28, 2026MalfunctionConvatec Dominican Republic Inc9618003-2026-01624
- DUODERMJul 28, 2026MalfunctionConvatec Dominican Republic Inc9618003-2026-01625
- DUODERMJul 28, 2026MalfunctionConvatec Dominican Republic Inc9618003-2026-01626
- DUODERMJul 28, 2026MalfunctionConvatec Dominican Republic Inc9618003-2026-01627
- DUODERMJul 28, 2026MalfunctionConvatec Dominican Republic Inc9618003-2026-01629
- DUODERMJul 28, 2026MalfunctionConvatec Dominican Republic Inc9618003-2026-01628
Event type breakdown
Recalls
19 recall events for this product code
- ConvaTec, IncOpen, ClassifiedOct 16, 2025
DuoDERM" Extra Thin dressings are highly flexible, control gel formula dressings designed for use on dry to lightly exudating wounds. DuoDERM" Extra Thin dressi
Wound dressing may have foreign matter on the product.
Z-0160-2026 · View FDA record ↗ - MEDLINE INDUSTRIES, LP - NorthfieldOpen, ClassifiedApr 4, 2025
Wayson Hydrocolloid Models:
There is a potential for the sterility of the device to be compromised.
Z-1531-2025 · View FDA record ↗ - Covidien LLCTerminatedMar 27, 2017
Covidien Kerlix Super Sponge Saline Dressing, Sterile
Product sterility is compromised due to breach of sterile barrier
Z-1743-2017 · View FDA record ↗ - Covidien LLCTerminatedMar 27, 2017
Covidien Curity Sodium Chloride Dressing , 6 x 6-3/4 (15.2 cm x 17.1 cm), Sterile
Product sterility is compromised due to breach of sterile barrier
Z-1744-2017 · View FDA record ↗ - Covidien LLCTerminatedMar 27, 2017
Covidien Curity Saline Dressing 8' x 4 (20.3cm x10.2 cm), Sterile
Product sterility is compromised due to breach of sterile barrier
Z-1745-2017 · View FDA record ↗ - Coloplast Manufacturing US, LLCTerminatedOct 24, 2014
Biatain Super Non-Adhesive, Catalog number 46300, 10 pcs, REF 0463001400. Country of Origin:HU.
Coloplast is conducting a recall for one lot (4201931) of the Biatain Super Non-Adhesive wound dressing which was mislabeled.
Z-0138-2015 · View FDA record ↗ - Aplicare, Inc.TerminatedApr 8, 2010
Aplicare Advantage Dressing Change System, Central Line Dressing Change, Sterile
Incorrect expiration date on outer kit label-extended.
Z-1310-2010 · View FDA record ↗ - Kendall Healthcare Products CoTerminatedJul 20, 2004
Kendall Kerlix A.M.D. Antimicrobial Large Roll, Sterile
Sterility compromised due to lack of package seal integrity
Z-0380-04 · View FDA record ↗ - Kendall Healthcare Products CoTerminatedJul 20, 2004
Kendall Kerlix Large Roll, 4.5 in X 4.1 yd, Sterile
Sterility compromised due to lack of package seal integrity
Z-0381-04 · View FDA record ↗ - Kendall Healthcare Products CoTerminatedJul 20, 2004
Kendall Curity Disposable Laparotomy Sponges,
Sterility compromised due to lack of package seal integrity
Z-0382-04 · View FDA record ↗
Registered firms
542 firms currently registered for this product code
Nurimedics Co., Ltd
Gimpo-si Gyeonggi, KR
Anji Hengyun Weaving Co., Ltd.
Huzhou Zhejiang, CN
Yafho Bio-technology Co., Ltd.
GUANGZHOU Guangdong, CN
Hollister Incorporated
STUARTS DRAFT, VA, US
Human Biosciences, Inc.
Martinsburg, WV, US
Anping Guardian Medical Equipment Co.,ltd
Hengshui Hebei, CN
Steriservices
Bernay Eure, FR
Bard Reynosa S.a. De C.v.
REYNOSA Tamaulipas, MX
Shanghai Newvalue Medical Products Co.,ltd.
Shanghai, CN
Synergy Health Sterilisation Uk Ltd
Daventry Northamptonshire, GB
Zhejiang Haomep Medical Products Co.,ltd
YIWU Zhejiang, CN
Toc Logistics / Sol-millenium Canada, Inc.
Maple Ontario, CA
Jiangsu Nanfang Medical Co., Ltd.
CHANGZHOU Jiangsu, CN
Medifab Co., Ltd.
Geumcheon-gu Seoul, KR
Apr Co., Ltd.
Seoul, KR
Ready Set Import
Beverly Hills, CA, US
Remedy First
Ogden, UT, US
K-one Meditech Sdn. Bhd
Ipoh Perak, MY
Avery Dennison Medical Ltd.
Longford, IE
Planet(shanghai) International Co.,ltd
shanghai, CN
Dermaject Co.,ltd
Seongnam-si Gyeonggi, KR
Parafix Tapes & Conversions Limited
Lancing West Sussex, GB
Productos Medline S.a. De C.v.
NUEVO LAREDO Tamaulipas, MX
Sterigenics Germany Gmbh
Wiesbaden Hesse, DE
Sna Safehealth Solutions Inc.
Monrovia, CA, US
510(k) clearances
107 clearances for this product code
- Sam Medical ProductsMar 3, 2011
K102403 · SAM CHEST SEAL WITH VAVLE; SAM CHEST SEAL
- Aplion Medical,LlcMay 20, 2009
K091133 · APLION TOPICAL CARE SYSTEM
- Teikoku Pharma USA, Inc.Jun 17, 2008
K072560 · ENVELA (HYDROHESIVE OCCLUSIVE DRESSING)
- Tri-State Hospital Supply Corp.Apr 23, 2008
K080524 · CENTURION SORBAVIEW OTC
- Enzysurge , Ltd.Feb 27, 2006
K060046 · DERMASTREAM
- Oxyband Technologies, Inc.Mar 24, 2005
K043063 · OXYBAND WOUND DRESSING
- Kinetic Concepts, Inc.May 6, 2002
K020781 · WET CHAMBER
- The Kendall Company, L.P.Jan 31, 2000
K990530 · KERLIX MD ANTIMICROBIAL GAUZE DRESSING