Open, ClassifiedPosted Aug 22, 2025·Initiated Jul 3, 2025
TRANSDUCER L12-5 Transducer Probe
Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Root cause: Device Design
Recalling firm: Philips Ultrasound, IncType: System, Imaging, Pulsed Doppler, UltrasonicDistribution: US Nationwide distribution.Recall #Z-2402-2025
Open, ClassifiedPosted Aug 22, 2025·Initiated Jul 3, 2025
V6-2 Transducer Probe
Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Root cause: Device Design
Recalling firm: Philips Ultrasound, IncType: System, Imaging, Pulsed Doppler, UltrasonicDistribution: US Nationwide distribution.Recall #Z-2403-2025
Open, ClassifiedPosted Aug 22, 2025·Initiated Jul 3, 2025
V9-2 Transducer Probe
Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Root cause: Device Design
Recalling firm: Philips Ultrasound, IncType: System, Imaging, Pulsed Doppler, UltrasonicDistribution: US Nationwide distribution.Recall #Z-2404-2025
Open, ClassifiedPosted Aug 22, 2025·Initiated Jul 3, 2025
VL13-5 Transducer Probe
Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Root cause: Device Design
Recalling firm: Philips Ultrasound, IncType: System, Imaging, Pulsed Doppler, UltrasonicDistribution: US Nationwide distribution.Recall #Z-2405-2025
Open, ClassifiedPosted Aug 22, 2025·Initiated Jul 3, 2025
X11-4t Transducer Probe
Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Root cause: Device Design
Recalling firm: Philips Ultrasound, IncType: System, Imaging, Pulsed Doppler, UltrasonicDistribution: US Nationwide distribution.Recall #Z-2406-2025
Open, ClassifiedPosted Aug 22, 2025·Initiated Jul 3, 2025
X3-1 Transducer Probe
Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Root cause: Device Design
Recalling firm: Philips Ultrasound, IncType: System, Imaging, Pulsed Doppler, UltrasonicDistribution: US Nationwide distribution.Recall #Z-2407-2025
Open, ClassifiedPosted Aug 22, 2025·Initiated Jul 3, 2025
X5-1 Transducer Probe
Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Root cause: Device Design
Recalling firm: Philips Ultrasound, IncType: System, Imaging, Pulsed Doppler, UltrasonicDistribution: US Nationwide distribution.Recall #Z-2408-2025
Open, ClassifiedPosted Aug 22, 2025·Initiated Jul 3, 2025
X5-1c Transducer Probe
Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Root cause: Device Design
Recalling firm: Philips Ultrasound, IncType: System, Imaging, Pulsed Doppler, UltrasonicDistribution: US Nationwide distribution.Recall #Z-2409-2025
Open, ClassifiedPosted Aug 22, 2025·Initiated Jul 3, 2025
X6-1 Transducer Probe
Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Root cause: Device Design
Recalling firm: Philips Ultrasound, IncType: System, Imaging, Pulsed Doppler, UltrasonicDistribution: US Nationwide distribution.Recall #Z-2410-2025
Open, ClassifiedPosted Aug 22, 2025·Initiated Jul 3, 2025
X7-2 Transducer Probe
Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Root cause: Device Design
Recalling firm: Philips Ultrasound, IncType: System, Imaging, Pulsed Doppler, UltrasonicDistribution: US Nationwide distribution.Recall #Z-2411-2025
Open, ClassifiedPosted Aug 22, 2025·Initiated Jul 3, 2025
X7-2t Transducer Probe
Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Root cause: Device Design
Recalling firm: Philips Ultrasound, IncType: System, Imaging, Pulsed Doppler, UltrasonicDistribution: US Nationwide distribution.Recall #Z-2412-2025
Open, ClassifiedPosted Aug 22, 2025·Initiated Jul 3, 2025
X8-2t Transducer Probe
Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Root cause: Device Design
Recalling firm: Philips Ultrasound, IncType: System, Imaging, Pulsed Doppler, UltrasonicDistribution: US Nationwide distribution.Recall #Z-2413-2025
Open, ClassifiedPosted Aug 22, 2025·Initiated Jul 3, 2025
XL14-3 Transducer Probe
Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Root cause: Device Design
Recalling firm: Philips Ultrasound, IncType: System, Imaging, Pulsed Doppler, UltrasonicDistribution: US Nationwide distribution.Recall #Z-2414-2025
Open, ClassifiedPosted Aug 22, 2025·Initiated Jul 14, 2025
Spectrum IQ Infusion Pump, Product Code 3570009
Reason: 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.
Root cause: Nonconforming Material/Component
Recalling firm: Baxter Healthcare CorporationType: Pump, InfusionDistribution: US distribution to states of: AZ, FLRecall #Z-2415-2025
Open, ClassifiedPosted Aug 22, 2025·Initiated Jul 24, 2025
Brand Name: THOR
Product Name: NovoTHOR
Model/Catalog Number: S2188
Software Version: N/A
Product Description: The NovoTHOR and NovoTHOR XL are intended to emit energy in the visible and IR spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary increase in local blood circulation, temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, muscle spasm, and temporary relaxation of muscles.
Component: No
Reason: 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.
Root cause: Process control
Recalling firm: THOR Photomedicine LtdType: Lamp, Infrared, Therapeutic HeatingDistribution: Worldwide distribution: US (nationwide): AK, AZ, CA, CO, CT, FL, GA, HI, ID, IN, MA, MD, NC, ND, NJ, NV, NY, OR, PA, TX, UT, VA, WA, WI, WV; and OUS (International): Australia, United Kingdom, Austria, Ireland, Italy, Lithuania, Netherlands, Poland, Serbia, Slovakia, Spain.Recall #Z-2416-2025
Open, ClassifiedPosted Aug 22, 2025·Initiated Jul 24, 2025
Brand Name: THOR
Product Name: NovoTHOR XL
Model/Catalog Number: S2190
Software Version: N/A
Product Description: The NovoTHOR and NovoTHOR XL are intended to emit energy in the visible and IR spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary increase in local blood circulation, temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, muscle spasm, and temporary relaxation of muscles.
Component: No
Reason: 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.
Root cause: Process control
Recalling firm: THOR Photomedicine LtdType: Lamp, Infrared, Therapeutic HeatingDistribution: Worldwide distribution: US (nationwide): AK, AZ, CA, CO, CT, FL, GA, HI, ID, IN, MA, MD, NC, ND, NJ, NV, NY, OR, PA, TX, UT, VA, WA, WI, WV; and OUS (International): Australia, United Kingdom, Austria, Ireland, Italy, Lithuania, Netherlands, Poland, Serbia, Slovakia, Spain.Recall #Z-2417-2025
Open, ClassifiedPosted Aug 22, 2025·Initiated Jul 24, 2025
Brand Name: THOR
Product Name: NovoTHOR Gen 3.0 Reg PRX
Model/Catalog Number: S2189
Software Version: N/A
Product Description: The NovoTHOR and NovoTHOR XL are intended to emit energy in the visible and IR spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary increase in local blood circulation, temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, muscle spasm, and temporary relaxation of muscles.
Component: N/A
Reason: 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.
Root cause: Process control
Recalling firm: THOR Photomedicine LtdType: Lamp, Infrared, Therapeutic HeatingDistribution: Worldwide distribution: US (nationwide): AK, AZ, CA, CO, CT, FL, GA, HI, ID, IN, MA, MD, NC, ND, NJ, NV, NY, OR, PA, TX, UT, VA, WA, WI, WV; and OUS (International): Australia, United Kingdom, Austria, Ireland, Italy, Lithuania, Netherlands, Poland, Serbia, Slovakia, Spain.Recall #Z-2418-2025
Open, ClassifiedPosted Aug 22, 2025·Initiated Jul 24, 2025
Brand Name: THOR
Product Name: NovoTHOR Gen 3.0 Reg PRX
Model/Catalog Number: S2186
Software Version: N/A
Product Description: The NovoTHOR and NovoTHOR XL are intended to emit energy in the visible and IR spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary increase in local blood circulation, temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, muscle spasm, and temporary relaxation of muscles.
Component: N/A
Reason: 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.
Root cause: Process control
Recalling firm: THOR Photomedicine LtdType: Lamp, Infrared, Therapeutic HeatingDistribution: Worldwide distribution: US (nationwide): AK, AZ, CA, CO, CT, FL, GA, HI, ID, IN, MA, MD, NC, ND, NJ, NV, NY, OR, PA, TX, UT, VA, WA, WI, WV; and OUS (International): Australia, United Kingdom, Austria, Ireland, Italy, Lithuania, Netherlands, Poland, Serbia, Slovakia, Spain.Recall #Z-2419-2025
Open, ClassifiedPosted Aug 22, 2025·Initiated Jul 14, 2025
Corin Operating Tables
Model Numbers: (1) 770001A0, (2) 770001A2, (3) 770001B0, (4) 770001B2, (5) 770001F0, (6) 770001F2;
All Software Versions.
Reason: 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.
Root cause: Under Investigation by firm
Recalling firm: MAQUET GMBHType: Table, Operating-Room, Ac-PoweredDistribution: Worldwide - US Nationwide distribution in the states of KY, NY, TX and the countries of Algeria, Australia, Austria, Bulgaria, Canada, China, Colombia, Denmark, Egypt, Estonia, Finland, France, Germany, Ireland, Israel, Italy, Japan, Jordan, Korea, Republic of, Kuwait, Lebanon, Morocco, Netherlands, Norway, Poland, Portugal, Romania, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom.Recall #Z-2420-2025
Open, ClassifiedPosted Aug 21, 2025·Initiated Jul 22, 2025
OtoLase Starter Kit;
UPN: AC-2003748.
Indicated for a
variety of surgical uses including ablation, coagulation, incision, excision, and vaporization of soft tissue.
Reason: The potential for unsterilized product within finished product labeled as sterile.
Root cause: Nonconforming Material/Component
Recalling firm: LUMENIS, LTD.Type: Powered Laser Surgical InstrumentDistribution: Domestic: PA, WI;
International: Germany, India;Recall #Z-2344-2025