Recalls published in September 2025
Everything the FDA, USDA FSIS, CPSC and NHTSA announced in September 2025, newest first.
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Class II · 1+ years ago
Diagnostica Stago, Inc. STA Satellite. Product Code: All references. All software recall: Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen
Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
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Class III · 1+ years ago
Philips Ultrasound, Inc eL18-4 Transducer Probe recall: To provide clarification and labelling to define the useful life
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
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Class III · 1+ years ago
Philips Ultrasound, Inc C6-3 Transducer Probe recall: To provide clarification and labelling to define the useful life
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
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Class II · 1+ years ago
American Contract Systems, Medical Procedure kits and trays labeled recall: During an internal investigation, ACS determined that the rationale
During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some…
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Class III · 1+ years ago
Philips Ultrasound, Inc mL26-8 Transducer Probe recall: To provide clarification and labelling to define the useful life
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
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Class II · 1+ years ago
Orascoptic Superior Visualization Dragonfly Nose Pad Accessory Kit 1 pk recall: Due to complaints, loupe nose pads containing nickel may cause an allergic
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
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Class III · 1+ years ago
Philips Ultrasound, Inc D2cwc Transducer Probe recall: To provide clarification and labelling to define the useful life
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
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Class II · 1+ years ago
American Contract Systems, Medical Procedure kits and trays labeled recall: During an internal investigation, ACS determined that the rationale
During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some…
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Class II · 1+ years ago
Diagnostica Stago, Inc. STA-Liquid Anti-Xa 4. Model/ recall: Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen
Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
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Class II · 1+ years ago
Dentsply IH, Inc. Brand Name: Atlantis IO FLO Product Name: Atlantis IO FLO-S Kit recall: The defect in the thread area will not allow the device to fully engage
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…
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Class III · 1+ years ago
Philips Ultrasound, Inc L18-5 Transducer Probe recall: To provide clarification and labelling to define the useful life
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
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Class III · 1+ years ago
Philips Ultrasound, Inc 3D9-3v Transducer Probe recall: To provide clarification and labelling to define the useful life
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
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Class III · 1+ years ago
Bausch & Lomb Surgical, Inc. Akreos, SKU: AO60P0300. Akreos intraocular lenses recall: An off-power error was identified, which resulted in a diopter of 16
An off-power error was identified, which resulted in a diopter of 16, rather than the intended 3 diopter. Implantation of affected intraocular lens…
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Class III · 1+ years ago
Philips Ultrasound, Inc C9-2 Transducer Probe recall: To provide clarification and labelling to define the useful life
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
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Class III · 1+ years ago
Philips Ultrasound, Inc OMNI II TEE Transducer Probe recall: To provide clarification and labelling to define the useful life
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
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Class III · 1+ years ago
Philips Ultrasound, Inc S4-2 Transducer Probe recall: To provide clarification and labelling to define the useful life
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
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Class III · 1+ years ago
Philips Ultrasound, Inc S4-1 Lumify Transducer Probe recall: To provide clarification and labelling to define the useful life
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
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Class III · 1+ years ago
Philips Ultrasound, Inc VL13-5 Transducer Probe recall: To provide clarification and labelling to define the useful life
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
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Class III · 1+ years ago
Philips Ultrasound, Inc C8-4v Transducer Probe recall: To provide clarification and labelling to define the useful life
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
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Class II · 1+ years ago
American Contract Systems, Medical Procedure kits and trays labeled recall: During an internal investigation, ACS determined that the rationale
During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some…
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Class II · 1+ years ago
Vantive Us Healthcare LLC PrisMax V2-US, Hemodialysis Delivery System recall: Low deaeration chamber level at post priming tests may lead to PrisMax System
Low deaeration chamber level at post priming tests may lead to PrisMax System alarm T2309: Air Detected in Prime resulting in multiple additional…
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Class III · 1+ years ago
Philips Ultrasound, Inc X5-1 Transducer Probe recall: To provide clarification and labelling to define the useful life
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
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Class II · 1+ years ago
Brand Name: Thor Product Name: NovoThor Gen 3.0 Reg PRX Model/ recall: The potential for a failed welded nut to shear off. When this occurs
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…
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Class III · 1+ years ago
Philips Ultrasound, Inc C10-4ec Transducer Probe recall: To provide clarification and labelling to define the useful life
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.