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Consumer Product Recalls
127,277 recalls from the U.S. Consumer Product Safety Commission, newest first.
August 6, 2025Medical DevicesFDA
Volcano Corp recalls Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P; PV.014P RX, REF: 014R; and PV.018, REF: 86700, 8
Hazard: 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"
August 6, 2025Medical DevicesFDA
INSTITUT GEORGES LOPEZ recalls Brand Name: Celsior Cold Storage Solution Product Name: Celsior Cold Storage Solution Model/Catalog Number: 533682 Pr
Hazard: The potential for risk of microbiological contamination of products due to inability to ensure sterility assurance throughout aseptic manufacturing.
August 6, 2025Medical DevicesFDA
FUJIFILM Healthcare Americas Corporation recalls ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynt
Hazard: Devices had an unapproved slabbing software function enabled for use.
August 6, 2025Medical DevicesFDA
Philips North America recalls Upgrade to MR 7700 Model Number (REF): 782130;
Hazard: 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.
August 6, 2025Medical DevicesFDA
Philips North America recalls SmartPath to Ingenia Elition X Model Numbers (REF): (1) 782118, (2) 782144;
Hazard: 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.
August 6, 2025Medical DevicesFDA
Philips North America recalls SmartPath to dStream for XR and 3.0T Model Numbers (REF): (1) 781270, (2) 782113, (3) 782129;
Hazard: 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.
August 6, 2025Medical DevicesFDA
Philips North America recalls SmartPath to dStream for 3.0T Model Number (REF): 782145;
Hazard: 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.
August 6, 2025Medical DevicesFDA
Philips North America recalls MR 7700 Model Numbers (REF): (1) 782120, (2) 782153;
Hazard: 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.
August 6, 2025Medical DevicesFDA
Philips North America recalls MR 5300 Model Numbers (REF): (1) 782110, (2) 782135 (China ONLY), (3) 782152;
Hazard: 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.
August 6, 2025Medical DevicesFDA
Philips North America recalls Intera 3.0T Quasar Dual Model Number (REF): 781150;
Hazard: 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.
August 6, 2025Medical DevicesFDA
Philips North America recalls Ingenia Elition X Model Numbers (REF): (1) 781358, (2) 782107, (3) 782119, (4) 782136, (5) 782151 (China ONLY);
Hazard: 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.
August 6, 2025Medical DevicesFDA
Philips North America recalls Ingenia Elition S Model Numbers (REF): (1) 781357, (2) 782106, (3) 782137, (4) 782150 (China ONLY);
Hazard: 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.
August 6, 2025Medical DevicesFDA
Philips North America recalls Ingenia Ambition X Model Numbers (REF): (1) 781356, (2) 782109, (3) 782138;
Hazard: 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.
August 6, 2025Medical DevicesFDA
Philips North America recalls Ingenia Ambition S Model Numbers (REF): (1) 781359, (2) 782108, (3) 782133 (China ONLY), (4) 782139;
Hazard: 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.
August 6, 2025Medical DevicesFDA
Philips North America recalls Ingenia 3.0T CX Model Numbers (REF): (1) 781271, (2) 782105;
Hazard: 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.
August 6, 2025Medical DevicesFDA
Philips North America recalls Ingenia 3.0T Model Numbers (REF): (1) 781342, (2) 781377, (3) 782103;
Hazard: 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.
August 6, 2025Medical DevicesFDA
Philips North America recalls Ingenia 1.5T S Model Number (REF): 781347;
Hazard: 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.
August 6, 2025Medical DevicesFDA
Philips North America recalls Ingenia 1.5T Model Numbers (REF): (1) 781315, (2) 718641, (3) 781396, (4) 782101, (5) 782115, (6) 782140;
Hazard: 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.
August 6, 2025Medical DevicesFDA
Philips North America recalls Evolution Upgrade 3.0T Model Numbers (REF): (1) 782117, (2) 782143;
Hazard: 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.
August 6, 2025Medical DevicesFDA
Philips North America recalls Evolution Upgrade 1.5T Model Numbers (REF): (1) 782116, (2) 782148;
Hazard: 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.
August 6, 2025Medical DevicesFDA
Philips North America recalls Achieva XR; Model Numbers (REF): (1) 781153, (2) 781253;
Hazard: 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.
August 6, 2025Medical DevicesFDA
Philips North America recalls Achieva 3.0T; Model Numbers (REF): (1) 781177, (2) 781277, (3) 781278, (4) 781344, (5) 781345;
Hazard: 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.
August 6, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE010301
Hazard: SwabFlush syringes are affected by the ICU Medical recall of their SwabCap Disinfecting Cap due to a manufacturing issue which affects the seal between the foil lid and plastic container of the Swab Cap. The issue may result in a reduced level of disinfection of the luer access valve, potentially resulting in patient infection/sepsis.
August 6, 2025Medical DevicesFDA
Capnia Inc recalls Precision Sampling Set, REF: C20206 for use with the CoSense End-Tidal Carbon Monoxide Monitor
Hazard: Sampling set nasal cannula used with End-Tidal Carbon Monoxide (ETCO) monitor may have residual carbon monoxide and volatile organic compounds present due to insufficient aeration of the cannula's carbon filter prior to sealing, which may lead to higher than expected ETOCc scores during clinical evaluations.
August 6, 2025Medical DevicesFDA
LTS Therapy Systems, LLC recalls IontoPatch 80, On-the-Go Patch Therapy, Model/Catalog Number: D-0077-080; The IontoPatch is an Iontophoresis transderm
Hazard: The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with the device.
August 6, 2025Medical DevicesFDA
LTS Therapy Systems, LLC recalls IontoPatch STAT, On-the-Go Patch Therapy, Model/Catalog Number D-0062-080; IontoPatch is an Iontophoresis transdermal pa
Hazard: The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with the device.
August 6, 2025Medical DevicesFDA
Microbiologics Inc recalls LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894L
Hazard: KWIK-STIK REF numbers: 0894P, 0894K and LYFO DISK" 0894L may result in failure to recover the target microorganism. All lots of REF 894-76 are impacted.
August 6, 2025Medical DevicesFDA
Microbiologics Inc recalls LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894K (6-pack), 2) REF 0894P (2-pack)
Hazard: KWIK-STIK REF numbers: 0894P, 0894K and LYFO DISK" 0894L may result in failure to recover the target microorganism. All lots of REF 894-76 are impacted.
August 6, 2025Medical DevicesFDA
Maquet Cardiopulmonary Gmbh recalls Sprinter Cart/Sprinter Cart XL Infusion Pole. Component used to hold 2 x 2 kg infusion bags.
Hazard: Device does not comply with the labeling requirements of international standard IEC 60601-1.
August 6, 2025Medical DevicesFDA
Phasor Health, LLC recalls Phasor Drill, REF: 2.70S, 3.20L, 4.50, 5.30, 6.35
Hazard: Drill for use in neurosurgical procedures may have a reverse battery orientation, which may increase surgical time.