Medical device recalls
38684 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2025-08-06FDA-DeviceFresenius Kabi USA, LLCClass IILVP Primary Administration Set, Single Outlet Low Sorbing (Qty 25). Product Code: SET-0021-25.
Potential for external cassette leaks
- 2025-08-06FDA-DeviceFresenius Kabi USA, LLCClass IILVP Blood Products Administration Set Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter (Qty 20). Product Code: SET-0014-20.
Potential for external cassette leaks
- 2025-08-06FDA-DeviceFresenius Kabi USA, LLCClass IILVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25). Product Code: SET-0013-25.
Potential for external cassette leaks
- 2025-08-06FDA-Device3M CompanyClass II3M Ranger Irrigation Fluid Warming Set, REF 24750
Notice was issued to clarify flow rates related to the inlet fluid temperature.
- 2025-08-06FDA-DeviceSiemens Healthcare Diagnostics IncClass IIRAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097.
Siemens Healthcare Diagnostics is recalling the RAPIDPoint 500 Systems Wash/Waste Cartridge Lot WW/08925 due to a manufacturing error causing positive and negative bias in Ionized Calcium, Potassium, pH, Chloride, pCO2, Glucose and Lactate analytes and their derivatives. Four complaints were filed related to this event that led to Siemens Healthcare Diagnostics identifying an error in the manufacturing process and initiated corrective actions. Use of the affected device may result in errors during QC which could lead to a delay in patient treatment. If bias generated from this issue is not caught during QC erroneous results may cause temporary or medically reversible adverse health consequences to patients.
- 2025-08-06FDA-DeviceRemel, IncClass IIBlood/MacConkey Biplate 100/PK, Product Number R02049
The products may contain surface and subsurface contamination of Listeria monocytogenes.
- 2025-08-06FDA-DeviceRemel, IncClass IIBlood/EMB, Levine 100/PK, Product Number R02041
The products may contain surface and subsurface contamination of Listeria monocytogenes.
- 2025-08-06FDA-DeviceRemel, IncClass IIStrep Selective II Agar, Product Number R01859
The products may contain surface and subsurface contamination of Listeria monocytogenes.
- 2025-08-06FDA-DeviceRemel, IncClass IIBlood Agar,5% Sheep Blood 100/PK, Product Number R01202
The products may contain surface and subsurface contamination of Listeria monocytogenes.
- 2025-08-06FDA-DeviceOsteotec LimitedClass IIBrand Name: Osteotec Product Name: Osteotec Silicone Finger Implant Model/Catalog Number: OSTF-3 (Sz. 3), OSTF-4 (Sz. 4), OSTF-5 (Sz. 5) Software Version: N/A Product Description: The Osteotec Silicone Finger Implant is a one-piece, sterile, flexible silicone elastomer implant which is placed, during arthroplasty, in the proximal and distal intramedullary canals of either metacarpophalangeal (MCP) or proximal interphalangeal (PIP) joints. The implant is not fixed into the bones and become
There is the potential that the silicone implant may contain foreign material
- 2025-08-06FDA-DeviceVolcano CorpClass IIVolcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P; PV.014P RX, REF: 014R; and PV.018, REF: 86700, 86700J used with Instructions for use.
Reports of IVUS catheter and guide wire entanglement during radial-to-peripheral procedures, due to catheter use without appropriate sheath and/or guide catheter, which may require further intervention, such as surgical removal; Firm is restating instructions for use and adding: "Use a guide sheath of appropriate length to provide adequate support to the rapid exchange IVUS catheter and guidewire"
- 2025-08-06FDA-DeviceINSTITUT GEORGES LOPEZClass IIBrand Name: Celsior Cold Storage Solution Product Name: Celsior Cold Storage Solution Model/Catalog Number: 533682 Product Description: In US Celsior is a class II medical device. Celsior is a clear to slightly yellow, sterile, non pyrogenic solution for hypothermic flushing and storage of hearts. Celsior can be used for hypothermic cardiac flushing and storage in preparation for transportation and eventual transplantation of the heart into the recipient. Celsior is packaged in one liter b
The potential for risk of microbiological contamination of products due to inability to ensure sterility assurance throughout aseptic manufacturing.
- 2025-08-06FDA-DeviceFUJIFILM Healthcare Americas CorporationClass IIASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).
Devices had an unapproved slabbing software function enabled for use.
- 2025-08-06FDA-DevicePhilips North AmericaClass IIUpgrade to MR 7700 Model Number (REF): 782130;
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
- 2025-08-06FDA-DevicePhilips North AmericaClass IISmartPath to Ingenia Elition X Model Numbers (REF): (1) 782118, (2) 782144;
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
- 2025-08-06FDA-DevicePhilips North AmericaClass IISmartPath to dStream for XR and 3.0T Model Numbers (REF): (1) 781270, (2) 782113, (3) 782129;
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
- 2025-08-06FDA-DevicePhilips North AmericaClass IISmartPath to dStream for 3.0T Model Number (REF): 782145;
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
- 2025-08-06FDA-DevicePhilips North AmericaClass IIMR 7700 Model Numbers (REF): (1) 782120, (2) 782153;
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
- 2025-08-06FDA-DevicePhilips North AmericaClass IIMR 5300 Model Numbers (REF): (1) 782110, (2) 782135 (China ONLY), (3) 782152;
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
- 2025-08-06FDA-DevicePhilips North AmericaClass IIIntera 3.0T Quasar Dual Model Number (REF): 781150;
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
- 2025-08-06FDA-DevicePhilips North AmericaClass IIIngenia Elition X Model Numbers (REF): (1) 781358, (2) 782107, (3) 782119, (4) 782136, (5) 782151 (China ONLY);
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
- 2025-08-06FDA-DevicePhilips North AmericaClass IIIngenia Elition S Model Numbers (REF): (1) 781357, (2) 782106, (3) 782137, (4) 782150 (China ONLY);
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
- 2025-08-06FDA-DevicePhilips North AmericaClass IIIngenia Ambition X Model Numbers (REF): (1) 781356, (2) 782109, (3) 782138;
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
- 2025-08-06FDA-DevicePhilips North AmericaClass IIIngenia Ambition S Model Numbers (REF): (1) 781359, (2) 782108, (3) 782133 (China ONLY), (4) 782139;
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
- 2025-08-06FDA-DevicePhilips North AmericaClass IIIngenia 3.0T CX Model Numbers (REF): (1) 781271, (2) 782105;
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
- 2025-08-06FDA-DevicePhilips North AmericaClass IIIngenia 3.0T Model Numbers (REF): (1) 781342, (2) 781377, (3) 782103;
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
- 2025-08-06FDA-DevicePhilips North AmericaClass IIIngenia 1.5T S Model Number (REF): 781347;
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
- 2025-08-06FDA-DevicePhilips North AmericaClass IIIngenia 1.5T Model Numbers (REF): (1) 781315, (2) 718641, (3) 781396, (4) 782101, (5) 782115, (6) 782140;
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
- 2025-08-06FDA-DevicePhilips North AmericaClass IIEvolution Upgrade 3.0T Model Numbers (REF): (1) 782117, (2) 782143;
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
- 2025-08-06FDA-DevicePhilips North AmericaClass IIEvolution Upgrade 1.5T Model Numbers (REF): (1) 782116, (2) 782148;
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
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