September 3, 2025Medical DevicesFDA
Orascoptic Surgical Acuity recalls Orascoptic Superior Visualization Dragonfly Nose Pad Accessory Kit ( nose pad and screw) 1 pk and 20 pk.
Hazard: Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
September 3, 2025Medical DevicesFDA
Orascoptic Surgical Acuity recalls Orascoptic Superior Visualization Phantom Essential kit ( Nose pad, a screw, lens cleaning wipe, side shields, head st
Hazard: Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
September 3, 2025Medical DevicesFDA
Orascoptic Surgical Acuity recalls Orascoptic Superior Visualization Dragonfly Essentials Kit ( Nose pad, a screw, lens cleaning wipe, side shields, head
Hazard: Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
September 3, 2025Medical DevicesFDA
Orascoptic Surgical Acuity recalls Orascoptic Superior Visualization Custom loupes configured with Phantom Frames
Hazard: Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
September 3, 2025Medical DevicesFDA
Orascoptic Surgical Acuity recalls Orascoptic Superior Visualization Custom loupes with Dragonfly frames
Hazard: Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
September 3, 2025Medical DevicesFDA
VANTIVE US HEALTHCARE LLC recalls TherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630, 955515, 955702, 955631
Hazard: Thermax System may be unable to detect the presence of a bag on the Thermax Blood Warmer Unit leading to difficulty setting up therapy, or PrisMax System alarm T2284: Thermax Disposable Not Inserted
September 3, 2025Medical DevicesFDA
VANTIVE US HEALTHCARE LLC recalls PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724
Hazard: Unexpected PrisMax System alarm T0830: Blood Leak Detected, when no blood leak is present, or difficulty normalizing the Blood Leak Detector (BLD) leading to PrisMax System alarms T1313: BLD Normalize Failed, T0853: Normalization Failed, or T1205: BLD Self-Test Failure
September 3, 2025Medical DevicesFDA
VANTIVE US HEALTHCARE LLC recalls PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701
Hazard: Low deaeration chamber level at post priming tests may lead to PrisMax System alarm T2309: Air Detected in Prime resulting in multiple additional priming cycles
September 3, 2025Medical DevicesFDA
Onkos Surgical, Inc. recalls ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED, SLOTTED. Canal filling stem implants.
Hazard: Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
September 3, 2025Medical DevicesFDA
Onkos Surgical, Inc. recalls ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS SEGMENTAL STEM CANAL FILLING STRAIGHT SLOTTED SPLINED 2/3 PLASMA. Canal filli
Hazard: Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
September 3, 2025Medical DevicesFDA
Onkos Surgical, Inc. recalls ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. Canal filling stem implants.
Hazard: Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
September 3, 2025Medical DevicesFDA
Dentsply IH, Inc. recalls Brand Name: Atlantis IO FLO Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04S / 6802034 Product Descript
Hazard: The defect in the thread area will not allow the device to fully engage with an implant or analog (implant replica used for prosthetic modeling). The threads will only engage approximately 2 rotations as opposed to full engagement which is approximately 5 rotations. This equates to approximately 1mm difference in depth of engagement.
September 3, 2025Medical DevicesFDA
Dentsply IH, Inc. recalls Brand Name: Atlantis IO FLO-S Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04B / 68020033 Software Vers
Hazard: The defect in the thread area will not allow the device to fully engage with an implant or analog (implant replica used for prosthetic modeling). The threads will only engage approximately 2 rotations as opposed to full engagement which is approximately 5 rotations. This equates to approximately 1mm difference in depth of engagement.
September 3, 2025Medical DevicesFDA
MAQUET GMBH recalls Corin Operating Tables Model Numbers: (1) 770001A0, (2) 770001A2, (3) 770001B0, (4) 770001B2, (5) 770001F0, (6) 770001F
Hazard: Under certain conditions, such as the simultaneous use of the operating table with other medical devices, including high-frequency (HF) surgical equipment, interference may occur that could prevent the device from performing as intended. If the issue occurs, the operating table is unresponsive to command from both the universal remote control and override panel.
September 3, 2025Medical DevicesFDA
THOR Photomedicine Ltd recalls Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Number: S2186 Software Version: N/A Product De
Hazard: The potential for a failed welded nut to shear off. When this occurs, the gas strut on one side of the device becomes detached from the canopy, making the canopy difficult to lift.
September 3, 2025Medical DevicesFDA
THOR Photomedicine Ltd recalls Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Number: S2189 Software Version: N/A Product De
Hazard: The potential for a failed welded nut to shear off. When this occurs, the gas strut on one side of the device becomes detached from the canopy, making the canopy difficult to lift.
September 3, 2025Medical DevicesFDA
THOR Photomedicine Ltd recalls Brand Name: THOR Product Name: NovoTHOR XL Model/Catalog Number: S2190 Software Version: N/A Product Description: Th
Hazard: The potential for a failed welded nut to shear off. When this occurs, the gas strut on one side of the device becomes detached from the canopy, making the canopy difficult to lift.
September 3, 2025Medical DevicesFDA
THOR Photomedicine Ltd recalls Brand Name: THOR Product Name: NovoTHOR Model/Catalog Number: S2188 Software Version: N/A Product Description: The N
Hazard: The potential for a failed welded nut to shear off. When this occurs, the gas strut on one side of the device becomes detached from the canopy, making the canopy difficult to lift.
September 3, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls Spectrum IQ Infusion Pump, Product Code 3570009
Hazard: Baxter has identified that certain pumps have potentially been released with the grease applied to the cam and motor gears that will break down quickly. The breakdown of the grease will lead to the device having insufficient or ineffective grease applied to the cam, which could lead to premature wear of the mechanism assembly, resulting in excessive therapy.
September 3, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls XL14-3 Transducer Probe
Hazard: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
September 3, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls X8-2t Transducer Probe
Hazard: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
September 3, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls X7-2t Transducer Probe
Hazard: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
September 3, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls X7-2 Transducer Probe
Hazard: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
September 3, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls X6-1 Transducer Probe
Hazard: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
September 3, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls X5-1c Transducer Probe
Hazard: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
September 3, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls X5-1 Transducer Probe
Hazard: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
September 3, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls X3-1 Transducer Probe
Hazard: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
September 3, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls X11-4t Transducer Probe
Hazard: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
September 3, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls VL13-5 Transducer Probe
Hazard: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
September 3, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls V9-2 Transducer Probe
Hazard: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.