155 results
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14ms
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Sources: EU EUDAMED, US FDA
FERNO POWER X1 AMBULANCE COT- Item #0015807/UDI-DI 00190790002183 with 36V Li-Ion Batteries Model Number #0822484/0822483 Note: Transcend Stair Chair Powertraxx (Item #0731403/UDI-DI 00190790004064) not included in this action).
FDA Recall
Open, Classified
·Ferno-Washington Inc·Product code FPO·October 7, 2022
Option"ELITE Vena Cava Filter System REF 352506070E UDI-DI code: 00886333217151 The Option"ELITE Filter is indicated for the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the inferior vena cava (IVC) in the following conditions: " Pulmonary thromboembolism when anticoagulants are contraindicated " Failure of anticoagulant therapy in thromboembolic disease " Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced " Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated
FDA Recall
Open, Classified
·Argon Medical Devices, Inc·Product code DTK·September 12, 2025
CADD Solis HSPCA Pump
FDA Recall
Open, Classified
·Smiths Medical ASD, Inc.·Product code MEA·April 10, 2025
MED-810A Zemits NDPrime Laser products
FDA Recall
Open, Classified
·Advance-Esthetic LLC·Product code GEX·October 9, 2023
EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5
FDA Recall
Open, Classified
·Staar Surgical AG Haupt Strasse 104 Nidau Switzerland·Product code QCB·January 21, 2026
EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
FDA Recall
Open, Classified
·Staar Surgical Company·Product code MTA·September 29, 2023
EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_13.2. Phakic Toric Intraocular lens.
FDA Recall
Open, Classified
·Staar Surgical Company·Product code QCB·September 29, 2023
EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
FDA Recall
Open, Classified
·Staar Surgical Company·Product code MTA·September 29, 2023
EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.
FDA Recall
Open, Classified
·Staar Surgical Company·Product code MTA·September 29, 2023
EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.1. Phakic Toric Intraocular lens.
FDA Recall
Open, Classified
·Staar Surgical Company·Product code QCB·September 29, 2023
EVO+VISIAN Implantable Collamer Lens, REF:VTICM5_13.7. Phakic Toric Intraocular lens.
FDA Recall
Open, Classified
·Staar Surgical Company·Product code QCB·September 29, 2023
EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
FDA Recall
Open, Classified
·Staar Surgical Company·Product code MTA·September 29, 2023
EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
FDA Recall
Open, Classified
·Staar Surgical Company·Product code MTA·September 29, 2023
Diowave Laser System, REF: Diowave 250W
FDA Recall
Open, Classified
·Technological Medical Advancements LLC·Product code ILY·January 9, 2026
EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.6. Phakic Toric Intraocular lens.
FDA Recall
Open, Classified
·Staar Surgical Company·Product code QCB·September 29, 2023
EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.
FDA Recall
Open, Classified
·Staar Surgical Company·Product code MTA·September 29, 2023
EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
FDA Recall
Open, Classified
·Staar Surgical Company·Product code MTA·September 29, 2023
The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004.
FDA Recall
Open, Classified
·Fresenius Kabi USA, LLC·Product code FRN·February 4, 2026
MiniMed 780G Insulin Pump Catalog Numbers: MMT-1884 MMT-1886 With Software Version 6.60 The MiniMed 780G insulin pump is indicated for use by patients age 7-80 years with Type 1 diabetes, whose total daily dose of insulin is 8 units per day or more. The MiniMed 780G system is intended for continuous delivery of basal insulin at selectable rates, and the administration of insulin boluses at selectable amounts for the management of type 1 diabetes mellitus in persons seven years of age and older requiring insulin. The system is also intended to continuously monitor glucose values in the fluid under the skin. The MiniMed 780G system includes SmartGuard technology, which can be programmed to automatically adjust insulin delivery based on continuous glucose monitoring (CGM) sensor glucose values and can suspend delivery of insulin when the SG value falls below or is predicted to fall below predefined threshold values.
FDA Recall
Open, Classified
·Medtronic MiniMed, Inc.·Product code OZP·November 2, 2025
Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States: BXB055902C, BXB063902C, BXB065902C, BXB067902C, BXB073902C, BXB075902C, BXB077902C, BXB083902C, BXB085902C, BXB087902C, BXB093902C, BXB095902C, BXB097902C *For Clinical use.
FDA Recall
Open, Classified
·W L Gore & Associates, Inc.·Product code PRL·July 1, 2024