28 results
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11ms
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Sources: EU EUDAMED, US FDA
Ami HTX.
FDA Recall
Open, Classified
·Spectral Instruments Inc·Product code RCE·May 13, 2025
Am I Pregnant? One Step HCG Pregnancy Test REF 100-17
FDA Recall
Open, Classified
·Universal Meditech Inc.·Product code LCX·May 22, 2023
V.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTDEV01 The 3M" V.A.C. Ulta Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy with an instillation option.
FDA Recall
Open, Classified
·KCI USA, INC.·Product code OMP·November 5, 2024
3M Prevena Plus 125 Therapy Unit and System Kits REF: PRE3021US Prevena Plus Duo Peel and Place 20cm System Kit, US PRE3201US Prevena Plus Peel and Place 35 cm system Kit, US PRE3201 Prevena Plus Peel and Place 35 cm system Kit PRE4000US Prevena Plus 125 Therapy Unit, US PRE4001AU PREVENA PLUS SYSTEM KIT, AU PRE4001CA PREVENA PLUS SYSTEM KIT, CA PRE4001UK PREVENA PLUS SYSTEM KIT, UK PRE4001US PREVENA PLUS SYSTEM KIT, US PRE4001 PREVENA PLUS SYSTEM KIT PRE4001ZA PREVENA PLUS SYSTEM KIT, ZA PRE4010 PREVENA PLUS STANDALONE EXTENDED LIFE SYSTEM KIT PRE5001 PREVENA RESTOR ARTHRO-FORM SYSTEM KIT 33X30 CM PRE5101 PREVENA RESTOR ARTHRO-FORM SYSTEM KIT 46X30 CM PRE5221 PREVENA RESTOR BELLA-FORM SYSTEM KIT 21X19 CM PRE5321 PREVENA RESTOR BELLA-FORM SYSTEM KIT 24X22 CM PRE5421 PREVENA RESTOR BELLA-FORM SYSTEM KIT 29X27 CM PRE5501 PREVENA RESTOR AXIO-FORM SYSTEM KIT 29X28 CM
FDA Recall
Open, Classified
·KCI USA, INC.·Product code QFC·January 17, 2025
3M V.A.C. VIA Negative Pressure Wound Therapy System REF: VIAKIT077D01/US - V.A.C. VIA 7 Day Kit VIAKIT07S05/AU - V.A.C. VIA Starter Kit 65-Pack VIAKIT077D01/GB - V.A.C. VIA 7 Day Kit, Single Shipper
FDA Recall
Open, Classified
·KCI USA, INC.·Product code OMP·January 17, 2025
Skytron Ergon 3 Series Skyboom Monitor Bracket-Flatscreen Bracket, single monitor mount, 27" max. screen size Part number 3FCM1
FDA Recall
Open, Classified
·Skytron, Div. The KMW Group, Inc·Product code FQO·March 5, 2020
Skyton Bracket Flatscreen, Revision 2 & 3-The FS32 is a single monitor mounting bracket intended for use with a 32 inch (maximum) flat screen monitor. Model: FS32
FDA Recall
Open, Classified
·Skytron, Div. The KMW Group, Inc·Product code FQO·May 11, 2021
Product Name: GCX Channel Mounting Accessory Model/Catalog Number: H8-300-40-A
FDA Recall
Open, Classified
·Skytron, Div. The KMW Group, Inc·Product code FQO·June 2, 2022
Prevent G Safety Winged Blood Collection Set Glide - Rx Only -Sterile/EO - Product Usage: The IMPROSAFE Blood Collection Set is single-use, sterile, winged needle bonded to a flexible tubing with luer adapter. The needle consists of (1) a winged needle, (2) a flexible tubing, (3) a luer adaptor. (4) a safety shield, The products and evacuated blood collection tube/ syringe are used together for the collection of venous blood.
FDA Recall
Open, Classified
·Guangzhou Improve Medical Instruments Co., Ltd. NO.·Product code FMI·September 22, 2017
Arrow EZ-IO Intraosseous Vascular Access System 25mm Needle+Stabilizer Kit, Product Code 9001P-VC-005 - Product Usage: The Arrow EZ-IO Intraosseous Vascular Access System provides intraosseous access in the proximal humerus, proximal tibia, and distal tibia of adult and pediatric patients, and the distal femur in pediatric patients when vascular access is difficult to obtain in emergent, urgent, or medically necessary cases for up to 24 hours.
FDA Recall
Open, Classified
·Teleflex Medical·Product code FMI·October 8, 2019
Brand Name: NIO-A Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000603 Software Version: N/A Product Description: NIO devices are a spring-based, automatic intra-osseous access device supplied Sterile and single use. Indicated for Intra-osseous access to the Proximal humerus and Proximal Tibia in adult patients, in emergent situations. Component: N/A
FDA Recall
Open, Classified
·Waismed Ltd. 11, Galgalei Ha-Plada Pob 12135 Herzliya Israel·Product code FMI·June 5, 2025
Plastic Cannula HOLDEX Item # 450216 - Product Usage: - Product Usage: It is intended for use in routine specimen withdrawal from specimen collection bags or bottles through needleless cannula ports.
FDA Recall
Open, Classified
·C.A. Greiner & Sohne Gesellschaftmbh Greiner St. # 70 Kremsmunster Austria·Product code FMI·July 27, 2020
REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
FDA Recall
Open, Classified
·Bard Peripheral Vascular Inc·Product code FMI·July 27, 2021
VACUETTE SAFELINK, REF: 450210
FDA Recall
Open, Classified
·Greiner Bio-One GmbH Bad Haller Strase·Product code FMI·November 19, 2024
Arrow EZ-IO Intraosseous Vascular Access System 15mm Needle+Stabilizer Kit, Product Code 9018P-VC-005 - Product Usage: The Arrow EZ-IO Intraosseous Vascular Access System provides intraosseous access in the proximal humerus, proximal tibia, and distal tibia of adult and pediatric patients, and the distal femur in pediatric patients when vascular access is difficult to obtain in emergent, urgent, or medically necessary cases for up to 24 hours.
FDA Recall
Open, Classified
·Teleflex Medical·Product code FMI·October 8, 2019
Arrow EZ-IO Intraosseous Vascular Access System 45mm Needle+Stabilizer Kit, Product Code 9079P-VC-005 - Product Usage: The Arrow EZ-IO Intraosseous Vascular Access System provides intraosseous access in the proximal humerus, proximal tibia, and distal tibia of adult and pediatric patients, and the distal femur in pediatric patients when vascular access is difficult to obtain in emergent, urgent, or medically necessary cases for up to 24 hours.
FDA Recall
Open, Classified
·Teleflex Medical·Product code FMI·October 8, 2019
Brand Name: NIO+ Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000908 Software Version: N/A Product Description: NIO devices are a spring-based, automatic intraosseous access device supplied Sterile and single use. Indicated for Intraosseous access to the Proximal humerus and Proximal Tibia in adult patients, in emergent situations. Component: N/A
FDA Recall
Open, Classified
·Waismed Ltd. 11, Galgalei Ha-Plada Pob 12135 Herzliya Israel·Product code FMI·June 5, 2025
Apellis Injection Kit 29g Injection Needle -single use intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin and either an 18-gauge or a 19-gauge 5 micron filter needle. Ref: IVT-KIT-29G
FDA Recall
Open, Classified
·Apellis Pharmaceuticals, Inc.·Product code FMI·August 22, 2023
Improve Blood Collection Sets with Multiple Sample Luer Adapter - Sterile/EO Product Usage: The Blood Collection Set are single-use, sterile, winged needle bonded to a flexible tubing with luer adapter. The needle consists of (1) a winged needle, (2) a flexible tubing, (3) a luer adaptor. The products and evacuated blood collection tube/ syringe are used together for the collection of venous blood.
FDA Recall
Open, Classified
·Guangzhou Improve Medical Instruments Co., Ltd. NO.·Product code FMI·October 19, 2016
EasyTouch (ET) Insulin Syringe 29G 1ml " (Item 829155) Product Usage: INTENDED FOR INJECTION OF U100 INSULIN ONLY
FDA Recall
Open, Classified
·MHC Medical Products LLC·Product code FMI·April 6, 2018