47 results · 10ms · Sources: EU EUDAMED, US FDA

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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

FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended for use in general purpose radiography for generating radiographic images of human anatomy, including adult, pediatric, and neonatal exams

FDA Recall
Open, Classified ·FUJIFILM Healthcare Americas Corporation·Product code IZL·February 27, 2023

KLS martin Group KLS E-COUPLING ADAPTER REF PDEC-1000-2 E-Coupling Adapter Assembly used to connect the KLS driver (e.g. drill) to a driver bit that fits into the adapter.

FDA Recall
Open, Classified ·Pro-Dex Inc·Product code GET·February 14, 2023

KLS Martin Battery Pack, REF: KLS BP2 001, and KLS BP2 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver 2.0 surgical driver, REF: KLS-SD-2000

FDA Recall
Open, Classified ·Pro-Dex Inc·Product code MOQ·September 23, 2024

KLS Martin Battery Pack, REF: KLS BP 001, and KLS BP 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver

FDA Recall
Open, Classified ·Pro-Dex Inc·Product code GEY·February 15, 2023

GaGa Pro Lighting Equipment Co. Ltd. manufactures Class IV Laser Light Show (LLS)projectors for the purposes of demonstration and entertainment.

FDA Recall
Open, Classified ·GAGA PRO LIGHTING EQUIPMENT CO.·Product code REA·September 23, 2022

DORO Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)

FDA Recall
Open, Classified ·Pro-Med Instruments Gmbh BOETZINGER STRASSE 86 Freiburg Im Breisgau Germany·Product code HBL·March 14, 2025

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