62 results
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74ms
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Sources: EU EUDAMED, US FDA
Integra Suction Reservoir Kit for use with Integra NeuroSciences Subdural Drainage Catheter; Sterile, Rx only. Manufactured by Integra NeuroSciences Implants S.A., Sophia Antipolis Cedex, France; distributed by Integra NeuroSciences, 311 Enterprise Drive, Plainsboro, NJ 08538; This product is distributed by Integra NeuroSciences under catalog number 910-500 and in Suction Valve Reservoir Kits under catalog number 31223 and 31253.
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code GCY·May 7, 2010
Integra NeuroSciences, Combo Kit, Lot 171237, Integra LifeSciences 3498 West 2400 South, West Valley City, UT 84119. A kit for cranial access containing multiple necessary components to create the burr hole which is used to gain access to the cranial vault for the purpose of providing a portal for catheter placement.
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code HBG·February 22, 2011
Codman Microsensor Basic Kit. Catalog Number: 626631US. Use of the CODMAN MICROSENSOR Basic Kit is indicated when direct ICP monitoring is required. The kit is indicated for use in both subdural and intraparenchymal pressure monitoring applications only.
FDA Recall
Open, Classified
·Integra LifeSciences Corp. (NeuroSciences)·Product code GWM·December 12, 2025
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
Extended Tip Applicator, 8CM, Box of 5.
FDA Recall
Open, Classified
·Integra LifeSciences Corp. (NeuroSciences)·Product code FMF·May 22, 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
Cytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015.
FDA Recall
Open, Classified
·Integra LifeSciences Corp. (NeuroSciences)·Product code KGN·March 19, 2026
Extended Tip Applicator, 15 CM, Box of 5.
FDA Recall
Open, Classified
·Integra LifeSciences Corp. (NeuroSciences)·Product code FMF·May 22, 2025
Extended Tip Applicator 8CM, Box of 1.
FDA Recall
Open, Classified
·Integra LifeSciences Corp. (NeuroSciences)·Product code FMF·May 22, 2025
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
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
CODMAN Disposable Perforator 9mm. Cranial Perforator.
FDA Recall
Open, Classified
·Integra LifeSciences Corp. (NeuroSciences)·Product code HBF·September 26, 2025
Codman CereLink ICP Sensor Basic Kit. Catalog Number: 826850. The Codman CereLink ICP Sensor Basic Kit consists of the CereLink ICP Sensor (ICP Sensor) and a 14-gauge Tuohy needle with stylet. The ICP Sensor is a nylon tube with a microminiature strain gauge pressure transducer (sensing element) mounted at one end and an electrical connector at the other end. It is designed for use with a Codman intracranial pressure monitoring device. The ICP Sensor Basic Kit is designed for use with the Codman Cranial Hand Drill. The drill facilitates access to the intraparenchymal area. The drill is also available as a component of the Codman Cranial Access Kit. Use of the ICP Sensor Basic Kit is indicated when direct ICP monitoring is required. The kit is indicated for use in both subdural and intraparenchymal pressure monitoring applications only.
FDA Recall
Open, Classified
·Integra LifeSciences Corp. (NeuroSciences)·Product code GWM·December 12, 2025
Cytal Burn Matrix 10x15 cm. Product ID: BMM1015.
FDA Recall
Open, Classified
·Integra LifeSciences Corp. (NeuroSciences)·Product code KGN·March 19, 2026
CODMAN Disposable Perforator, 14mm. Cranial perforator.
FDA Recall
Open, Classified
·Integra LifeSciences Corp. (NeuroSciences)·Product code HBF·April 11, 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
MicroMyst Applicator, Box of 5. Consisting of a multilumen applicator and filtered line for use with the Integra Flow Source for the controlled application of two liquids.
FDA Recall
Open, Classified
·Integra LifeSciences Corp. (NeuroSciences)·Product code FMF·May 23, 2025
Codman CerebroFlo EVD Catheter with Endexo Technology. Contains 5 sets. Product ID: 37.550.501. The CerebroFlo EVD Catheter is a 3.3 mm diameter (10 Fr.), 35 cm long polyurethane catheter for diverting cerebrospinal fluid (CSF) from the ventricles of the brain through a series of drainage holes near the catheter's bullet shaped tip.
FDA Recall
Open, Classified
·Integra LifeSciences Corp. (NeuroSciences)·Product code JXG·April 10, 2026