25 results
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13ms
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Sources: EU EUDAMED, US FDA
TriMed Countersink 1.7mm, HCS, REF HSINK-1.7, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.
FDA Recall
Open, Classified
·TriMed Inc.·Product code LXH·September 28, 2018
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 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
HCS - Headless Compression Screw System, Headless Compression Screw, Cannulated; Article Numbers: 31207-10, 31207-12, 31207-14, 31207-16, 31207-18, 31207-20, 31207-24, 31207-26, 31207-28, 31207-30, 31257-12, 31257-14, 31257-16, 31257-18, 31257-20, 31257-22, 31257-24, 31257-28, 31257-30, 31307-18, 31307-32, 31307-34, 31307-36, 31307-38, 31358-30, 31437-30, 31437-38, 31437-40, 31437-50, 31757-100, 31757-120, 31757-45, 31757-80, 31757-85, 31757-90.
FDA Recall
Open, Classified
·I.T.S. GmbH Autal 28 Lasnitzhohe Austria·Product code HWC·January 23, 2026
Brand Name: MediHoney Product Name: MediHoney Hydrogel Adhesive Sheet Model/Catalog Number: 31722, 31744 Product Description: MEDIHONEY HCS ADHESIVE SHEET DRESSING 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. 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 not require a secondary dressing.
FDA Recall
Open, Classified
·Integra LifeSciences Corp. (NeuroSciences)·Product code FRO·August 5, 2025
ACL, ST LUKES METHODIST 1CS Catalog Number: LMAC10AA
FDA Recall
Open, Classified
·American Contract Systems Inc·Product code OJH·May 15, 2024
AW Server 2.0, AW Server 3.0, AW Server 3.1, AW Server 3.2
FDA Recall
Open, Classified
·GE Medical Systems, SCS·Product code LLZ·September 5, 2025
GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems
FDA Recall
Open, Classified
·GE Medical Systems, SCS·Product code OWB·March 18, 2024
GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System
FDA Recall
Open, Classified
·GE Medical Systems SCS·Product code LLZ·May 8, 2026
GE Healthcare Innova IGS 6, Interventional fluoroscopic x-ray systems
FDA Recall
Open, Classified
·GE Medical Systems, SCS·Product code OWB·March 18, 2024
GE Healthcare Innova IGS 5, computed tomography x-ray system
FDA Recall
Open, Classified
·GE Medical Systems, SCS·Product code OWB·March 18, 2024
GE Healthcare Allia IGS 7 OR, Interventional fluoroscopic x-ray systems
FDA Recall
Open, Classified
·GE Medical Systems, SCS·Product code OWB·March 18, 2024
GE Healthcare Allia IGS 7, Interventional fluoroscopic x-ray systems
FDA Recall
Open, Classified
·GE Medical Systems, SCS·Product code OWB·March 18, 2024
GE Healthcare Interact Discovery RT, Interventional fluoroscopic x-ray systems
FDA Recall
Open, Classified
·GE Medical Systems, SCS·Product code OWB·March 18, 2024
GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems
FDA Recall
Open, Classified
·GE Medical Systems, SCS·Product code OWB·March 18, 2024
Senographe Pristina
FDA Recall
Open, Classified
·GE Medical Systems, SCS·Product code MUE·December 26, 2023
The "Pacifier Activated Lullaby" (PAL) System composed of three major components: 1) the PAL Player Module (aka Player Unit), 2) the PAL Pacifier Sensor, and 3) power supply. The system is designed to encourage and reinforce effective non-nutritive sucking of premature infants.
FDA Recall
Open, Classified
·Powers Medical Devices, LLC·Product code HCC·October 1, 2015
BrainFeedback Pro 2 Device - is intended as an instrument that provides a visual and auditory signal corresponding to the status of a patients physiological parameters so that the patient can control voluntarily these physiological parameters.
FDA Recall
Open, Classified
·RONAN MEDICAL LLC·Product code HCC·December 11, 2023
Curaplex Nasal Intubation Kit w/ 7mm Endotracheal Tube-To perform a nasal intubation to establish an airway in an emergency. Item Number: 023070S
FDA Recall
Open, Classified
·Sarnova HC, Llc·Product code LNZ·February 12, 2024
Curaplex Field Cric Kit with ET Tube, Item Number 36611. The kit provides healthcare professionals with an assortment of supplies to perform a cricothyrotomy.
FDA Recall
Open, Classified
·Sarnova HC, Llc·Product code CAE·November 6, 2023