48 results
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16ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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Medline custom medical procedure kits labeled as: 1) VP SHUNT CDS, REF CDS983470D; 2) 1/2X1/2 NEURO SPONGE PACK-LF, REF DYNJ0713177; 3) BURR HOLE SHUNT PACK, REF DYNJ56819D; 4) BURR HOLE SHUNT PACK, REF DYNJ56819F; 5) BURR HOLE SHUNT PACK, REF DYNJ56819G; 6) RO VP SHUNT PACK, REF PHS392834010D; 7) VP SHUNT, REF SYNJ10307A.
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code OFF·November 21, 2024
MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/APPLICATOR, 1.5oz tube (Model Number 31515) and 3.5oz tube (Model Number 31535)
FDA Recall
Open, Classified
·Integra LifeSciences Corp.·Product code FRO·September 13, 2024
Brand Name: MediHoney Product Name: MediHoney HCS Sheet Dressing with Leptospermum Model/Catalog Number: 31612, 31622, 31644 Product Description: MEDIHONEY HCS SHEET DRESSING with LEPTOSPERMUM HONEY is a moist wound dressing made of Leptospermum Honey (+15) in combination with a hydrogel collodial gelling agent. The gelling agent is contained within the dressing mass. The dressing contains 63%, by weight, Leptospermum Honey. As wound exudate is absorbed, the dressing which has a low pH and high osmolarity forms a gel. This assists in maintaining a moist environment for optimal wound healing, aids in autolytic debridement, and allows for non-traumatic removal. This product is an occlusive dressing, and does require a secondary dressing.
FDA Recall
Open, Classified
·Integra LifeSciences Corp. (NeuroSciences)·Product code FRO·August 5, 2025
Brand Name: MediHoney Product Name: MediHoney Adhesive Hydrogel Sheet Dressing Model/Catalog Number: 31720, 31740 Product Description: MEDIHONEY Adhesive Hydrogel Sheet Dressing with Leptospermum Honey is a moist wound dressing made of Leptospermum Honey (+15) in combination with a hydrogel gelling agent, surrounded by an adhesive border. The gelling agent is contained within the dressing mass. The dressing contains 100% Leptospermum Honey. As wound exudate is absorbed, the dressing which has a low pH and high osmolarity forms a gel. This assists in maintaining a moist environment for optimal wound healing, aids in autolytic debridement, and allows for non-traumatic removal. This product is an occlusive dressing, and does not require a secondary dressing.
FDA Recall
Open, Classified
·Integra LifeSciences Corp. (NeuroSciences)·Product code FRO·August 5, 2025
Medline Sterile Water, USP, 100mL, REF RDI30295
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code FRO·March 19, 2025
Brand Name: MediHoney Product Name: MediHoney Hydrogel Model/Catalog Number: 31620, 31640 Product Description: MEDIHONEY Non-Adhesive Hydrogel Sheet Dressing with Leptospermum Honey is a moist wound dressing made of Leptospermum Honey (+15) in combination with a hydrogel gelling agent. The gelling agent is contained within the dressing mass. The dressing contains 100%, Leptospermum Honey. As wound exudate is absorbed, the dressing which has a low pH and high osmolarity forms a gel. This assists in maintaining a moist environment for optimal wound healing, aids in autolytic debridement, and allows for non-traumatic removal. This product is an occlusive dressing, and does require a secondary dressing.
FDA Recall
Open, Classified
·Integra LifeSciences Corp. (NeuroSciences)·Product code FRO·August 5, 2025
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 MJSALINE7
FDA Recall
Open, Classified
·Product code FRO·January 5, 2026
MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1) 31012, (2) 31022, (3) 31045. MEDIHONEY CALCIUM ALGINATE DRESSING WITH ACTIVE LEPTOSPERMUM HONEY supports and aids autolytic debridement and is indicated for the management of moderately to heavily exuding wounds
FDA Recall
Open, Classified
·Integra LifeSciences Corp. (NeuroSciences)·Product code FRO·January 16, 2026
Gentell Hydrogel Ag 4x4, model no. GEN-11420 - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Saturated Gauze is indicated for partial and full thickness wounds, including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns and skin tears. It provides a moist wound environment for healing.
FDA Recall
Open, Classified
·Gentell, Inc·Product code FRO·February 27, 2020
Gentell Honey Hydrogel 4"x4" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number: GEN-11430 - Product Usage: Use Gentell Honey Hydrogel on wounds with little or no exudate, diabetic skin ulcers, venous stasis ulcers, first and second-degree burns, post-surgical incisions, cuts and abrasions
FDA Recall
Open, Classified
·Gentell, Inc·Product code FRO·March 26, 2020
Gentell Honey Hydrogel 2"x2" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number:GEN-11230 - Product Usage: Use Gentell Honey Hydrogel on wounds with little or no exudate, diabetic skin ulcers, venous stasis ulcers, first and second-degree burns, post-surgical incisions, cuts and abrasions.
FDA Recall
Open, Classified
·Gentell, Inc·Product code FRO·March 26, 2020
a. DYNAREX WeCare PETROLATUM JELLY, WHT 5GM (144/BX 6BX/CS) DYNREX Catalog #1140. b. DYNAREX Dynarex PETROLEUM JELLY, WHITE 4OZ TU(72/CS) DYNREX Catalog #1145
FDA Recall
Open, Classified
·Mckesson Medical-Surgical Inc. Corporate Office
9954 Maryland Drive
Deep Run Iii Ste. 4000
Richmond VA 23233·Product code FRO·May 25, 2022
Brand Name: MediHoney Product Name: MediHoney Paste Model/Catalog Number: 31505 Product Description: MediHoney Paste with Active Leptospermum Honey is a moist dressing made of 100% Active Leptospermum medical grade Honey. The dressing helps maintain a moist environment conducive to wound healing and helps aid and support autolytic debridement. The dressing can be removed without causing trauma to the wound when a primary dressing is used.
FDA Recall
Open, Classified
·Integra LifeSciences Corp. (NeuroSciences)·Product code FRO·August 5, 2025
MediHoney Gel with Active Leptospermum Honey. Model/Catalog Numbers: (1) 31805, (2) 31815. MediHoney Gel dressing with Active Leptospermum Honey provides a moist environment conducive to wound healing and is indicated for light to moderately exuding wounds.
FDA Recall
Open, Classified
·Integra LifeSciences Corp. (NeuroSciences)·Product code FRO·January 16, 2026
Absorbent dressings. a. DERMA SCIENCES, INC. McKesson PACKING STRIP, PLAIN 1/4"X5YDSSTR LF (12 MGM61 61- Catalog #61-59120. b. DERMA SCIENCES, INC. McKesson PACKING STRIP, PLAIN 1/2"X5YDSSTR LF (12/CS) MGM61 Catalog #61-59220. c. DERMA SCIENCES, INC. McKesson PACKING STRIP, PLAIN 1"X5YDS STR LF (12/CS) MGM61 Catalog #61-59320. d. DERMA SCIENCES, INC. MediHoney DRESSING, MEDIHONEY GEL STR TU0.5OZ (10/BX 4BX/CS) MGM61 Catalog #DUP31805. e. DERMA SCIENCES, INC DuPad PAD, ABD STR 8X10 (25/BX 8BX/CS) Catalog #DUP87810. f. DERMA SCIENCES, INC Shur-Conform Oil Emulsion non-adhering DRESSING, OIL EMULSION 3"X3"23251-210 DERSCI Catalog #DKC77041
FDA Recall
Open, Classified
·Mckesson Medical-Surgical Inc. Corporate Office
9954 Maryland Drive
Deep Run Iii Ste. 4000
Richmond VA 23233·Product code FRO·May 25, 2022
Gentell Hydrogel Ag 4oz. Tube, model no. - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Silver Antimicrobial Wound Dressing is indicated for partial and full thickness wounds, including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns and skin tears. It provides a moist wound environment for healing.
FDA Recall
Open, Classified
·Gentell, Inc·Product code FRO·February 27, 2020
Gentell Honey Hydrogel Hydrogel 4oz. Tube. Wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number: GEN-11340 - Product Usage: Use Gentell Honey Hydrogel on wounds with little or no exudate, diabetic skin ulcers, venous stasis ulcers, first and second-degree burns, post-surgical incisions, cuts and abrasions.
FDA Recall
Open, Classified
·Gentell, Inc·Product code FRO·March 26, 2020
Brand Name: MediHoney Gel Product Name: MediHoney Wound & Burn Dressing Gel Model/Catalog Number: 31815 Software Version: N/A Product Description: MediHoney Gel with Active Leptospermum Honey is a moist dressing made of Active Leptospermum Honey in combination with gelling agents. The gelling agents act to maintain the physical integrity and viscosity of the dressing upon application. As a percentage of the overall dressing, MediHoney Gel dressing contains 80% medical grade honey by weight. The dressing helps maintain a moist environment conducive to wound healing and helps aid and support autolytic debridement. The dressing can be removed without causing trauma to the wound when a primary dressing is used. Component: No
FDA Recall
Open, Classified
·Integra LifeSciences Corp.·Product code FRO·January 10, 2025
Brand Name: MediHoney Product Name: MediHoney HCS Surgical Adhesive Sheet Model/Catalog Number: 31738 Product Description: MEDIHONEY HCS SURGICAL ADHESIVE SHEET DRESSINGS with LEPTOSPERMUM HONEY is a moist wound dressing made of Leptospermum Honey (+15) in combination with a hydrogel colloidal gelling agent, surrounded by an adhesive border. The gelling agent is contained within the dressing mass. As wound exudate is absorbed, the dressing which has a low pH and high osmolarity forms a gel. This assists in maintaining a moist environment for optimal wound healing, aids and supports autolytic debridement, and allows for non-traumatic removal. The product is an occlusive dressing, and does not require a secondary dressing.
FDA Recall
Open, Classified
·Integra LifeSciences Corp. (NeuroSciences)·Product code FRO·August 5, 2025
Medline Sterile 0.9% Normal Saline, USP, 100mL, REF RDI30296
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code FRO·March 19, 2025