Dressing, Wound, Drug
Unknown
Recent MDR events
3,144 adverse event reports on file
- UNKJul 31, 2026InjuryArthrex, Inc.1220246-2026-04157
- MEDIHONEY GEL IN TUBE, .5 FL OZ TWISTOFF - STERILEJul 31, 2026InjuryDerma Sciences, Inc.3005920706-2026-00046
- Algidex Ag®+ I.V. Dressing, 1" (3 cm) Disc, 4 mm openingJul 30, 2026InjuryDeroyal Industries, Inc.2320762-2026-00015
- PolyMem MAX Silver Non-Adhesive Pad DressingJul 30, 2026InjuryFerris Mfg. Corp.1419520-2026-00011
- BIOPATCH, UNKNOWN SIZE/PRODUCT IDJul 27, 2026MalfunctionIntegra Neurosciences Pr2648988-2026-00020
- IRRISEPT ANTIMICROBIAL WOUND LAVAGEJul 21, 2026InjuryIrrimax CorporationMW5190883
- IRRISEPT ANTIMICROBIAL WOUND LAVAGEJul 21, 2026InjuryIrrimax CorporationMW5190884
- IRRISEPT ANTIMICROBIAL WOUND LAVAGEJul 21, 2026InjuryIrrimax CorporationMW5190885
- IRRISEPT ANTIMICROBIAL WOUND LAVAGEJul 21, 2026OtherIrrimax CorporationMW5190886
- IRRISEPT ANTIMICROBIAL WOUND LAVAGEJul 21, 2026InjuryIrrimax CorporationMW5190887
Event type breakdown
Recalls
82 recall events for this product code
- ConvaTec, IncOpen, ClassifiedJul 7, 2026
Aquacel Ag Surgical SP
Surgical dressing manufactured out of specification (greater thickness).
Z-2677-2026 · View FDA record ↗ - Oculus Technologies of Mexico, S.A. de C.V.Open, ClassifiedJun 1, 2026
PhaseOne Antimicrobial Solution, Model/Catalog Number: 15050
The recall is being conducted due to corrosion of the internal metallic spring within the sprayer component. This condition is caused by material incompatibility between the product solution and the stainless steel spring and may result in visible discoloration and the presence of trace levels of metallic elements (including iron, chromium, and nickel) in the solution during use.
Z-2275-2026 · View FDA record ↗ - Medline Industries, LPOpen, ClassifiedFeb 20, 2026
Medline Sterile Saline Wound Wash, Cleansing & Wound Irrigation, USP Normal Saline (0.9% Sodium Chloride), 7.1 FL OZ (210 mL), DBD-CAN,SPRAY,7.1-OZ,SALINE,WOUND
Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.
Z-1431-2026 · View FDA record ↗ - Medline Industries, LPOpen, ClassifiedFeb 20, 2026
Meijer STERILE saline wound wash, First Aid Cleansing Spray, 0.9% USP SODIUM CHLORIDE, 7.1FL OZ (210 mL), DBD-CAN,SPRAY,7.1-OZ,SALINE,WOUND WASH,S, Model Number
Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.
Z-1435-2026 · View FDA record ↗ - Integra LifeSciences Corp. (NeuroSciences)Open, ClassifiedFeb 13, 2026
MediHoney Gel with Active Leptospermum Honey. Model/Catalog Numbers: (1) 31805, (2) 31815.
Potential packaging failures, which could lead to a breach in the sterile barrier.
Z-1363-2026 · View FDA record ↗ - Integra LifeSciences Corp. (NeuroSciences)Open, ClassifiedFeb 13, 2026
MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1) 31012, (2) 31022, (3) 31045.
Potential packaging failures, which could lead to a breach in the sterile barrier.
Z-1364-2026 · View FDA record ↗ - Integra LifeSciences Corp. (NeuroSciences)Open, ClassifiedFeb 13, 2026
Private Label CVS. Model Number: CVS405406.
Potential packaging failures, which could lead to a breach in the sterile barrier.
Z-1365-2026 · View FDA record ↗ - Integra LifeSciences Corp. (NeuroSciences)Open, ClassifiedSep 3, 2025
Brand Name: MediHoney
Packaging failures were identified which could lead to a breach in the sterile barrier.
Z-2505-2025 · View FDA record ↗ - Integra LifeSciences Corp. (NeuroSciences)Open, ClassifiedSep 3, 2025
Brand Name: MediHoney
Packaging failures were identified which could lead to a breach in the sterile barrier.
Z-2506-2025 · View FDA record ↗ - Integra LifeSciences Corp. (NeuroSciences)Open, ClassifiedSep 3, 2025
Brand Name: MediHoney
Packaging failures were identified which could lead to a breach in the sterile barrier.
Z-2507-2025 · View FDA record ↗
Registered firms
1,133 firms currently registered for this product code
Cordica Medical, Inc. (formally Team Technologies, Inc.)
Haverhill, MA, US
Arch Therapeutics
Framingham, MA, US
Cardinal Health 200, Llc
Waukegan, IL, US
Gentell
Bristol, PA, US
Hydrofera, Llc.
Manchester, CT, US
Mainline Medical Dental Supply
North York Ontario, CA
Isomedix Operations Inc.
Chester, NY, US
Sterigenics Uk Limited
Chesterfield Derbyshire, GB
Deroyal Industries, Inc.
POWELL, TN, US
Medline Industries, Lp - Northfield
Northfield, IL, US
Hedonist Biochemical Technologies Co., Ltd.
TAIPEI, TW
Manukamed Limited Partnership
Masterton Wellington, NZ
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
Abigo Medical Ab
MOLNDAL Vastra Gotaland, SE
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
Convatec, Inc.
Greensboro, NC, US
Brightwake Ltd
Kirkby-in-Ashfield Nottinghamshire, GB
Sterigenics Us Llc
Gurnee, IL, US
Ufp Technologies, Inc.
Newburyport, MA, US
Transcoject Gmbh
NEUMUENSTER Schleswig-Holstein, DE
Synergy Health Sterilisation Uk Ltd
West Yorkshire Bradford, GB
Sterigenics U.s., Llc
Schaumburg, IL, US
Hubei V-medical Products Co., Ltd.
Xiantao Hubei, CN
Isomedix Operations Inc.
WHIPPANY, NJ, US
510(k) clearances
705 clearances for this product code
- Sonoma Pharmaceuticals, Inc.Jun 24, 2026
K261023 · Microdacyn Wound Irrigation Solution
- Silverceuticals, Inc.Jun 24, 2026
K251929 · SilverCeuticals® Antimicrobial Wound Gel
- Oneness Biotech Co., Ltd.Jun 17, 2026
K261638 · Bonvadis®
- Merit Medical Systems, Inc.May 13, 2026
K254073 · StatSeal Disc
- InnovaCorium, Inc.Apr 7, 2026
K254191 · IWD-Gel
- Letus CorporationMar 25, 2026
K252023 · MiraChlor Antimicrobial Wound Solution
- Solventum Germany GmbHMar 13, 2026
K251999 · Promogran Prisma Collagen Matrix with ORC and Silver
- Huizhou Foryou Medical Co., Ltd.Mar 11, 2026
K252028 · LUOFUCON® Antimicrobial Wound Gel
PMA approvals
1 premarket approvals for this product code