Class IIOngoingZ-2224-2025
Remel, Inc recalls Strep Selective II Agar
The products may contain surface and subsurface contamination of Listeria monocytogenes.
Remel, IncKSAug 6, 2025
2025 device recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1,405–1,416 of 2,908 recalls
Class IIOngoingZ-2223-2025
Remel, Inc recalls Blood Agar
The products may contain surface and subsurface contamination of Listeria monocytogenes.
Remel, IncKSAug 6, 2025
Class IIOngoingZ-2222-2025
Osteotec Limited recalls Brand Name: Osteotec Product Name: Osteotec Silicone Finger Implant Model/Catalog Num…
There is the potential that the silicone implant may contain foreign material
Osteotec LimitedAug 6, 2025
Class IIOngoingZ-2221-2025
Volcano Corp recalls Volcano Visions Digital IVUS Catheter: PV.014P (Platinum)
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…
Volcano CorpCAAug 6, 2025
Class IIOngoingZ-2220-2025
INSTITUT GEORGES LOPEZ recalls Brand Name: Celsior Cold Storage Solution Product Name: Celsior Cold Storage Solution…
The potential for risk of microbiological contamination of products due to inability to ensure sterility assurance throughout aseptic manufacturing.
INSTITUT GEORGES LOPEZAug 6, 2025
Class IIOngoingZ-2219-2025
FUJIFILM Healthcare Americas Corporation recalls ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE…
Devices had an unapproved slabbing software function enabled for use.
FUJIFILM Healthcare Am…MAAug 6, 2025
Class IIOngoingZ-2218-2025
Philips North America recalls Upgrade 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.
Philips North AmericaMAAug 6, 2025
Class IIOngoingZ-2217-2025
Philips North America recalls SmartPath to Ingenia Elition X Model Numbers (REF): (1) 782118
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.
Philips North AmericaMAAug 6, 2025
Class IIOngoingZ-2216-2025
Philips North America recalls SmartPath to dStream for XR and 3.0T Model Numbers (REF): (1) 781270
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.
Philips North AmericaMAAug 6, 2025
Class IIOngoingZ-2215-2025
Philips North America recalls SmartPath 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.
Philips North AmericaMAAug 6, 2025
Class IIOngoingZ-2214-2025
Philips North America recalls MR 7700 Model Numbers (REF): (1) 782120
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.
Philips North AmericaMAAug 6, 2025
Class IIOngoingZ-2213-2025
Philips North America recalls MR 5300 Model Numbers (REF): (1) 782110
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.
Philips North AmericaMAAug 6, 2025