Medical device recalls
38684 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2025-09-03FDA-DevicePhilips Ultrasound, IncClass IIIL12-4 Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- 2025-09-03FDA-DevicePhilips Ultrasound, IncClass IIIL12-3 Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- 2025-09-03FDA-DevicePhilips Ultrasound, IncClass IIIL11-3 Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- 2025-09-03FDA-DevicePhilips Ultrasound, IncClass IIIL10-4LAP Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- 2025-09-03FDA-DevicePhilips Ultrasound, IncClass IIIeL18-4 Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- 2025-09-03FDA-DevicePhilips Ultrasound, IncClass IIID5cwc Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- 2025-09-03FDA-DevicePhilips Ultrasound, IncClass IIID2TCD Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- 2025-09-03FDA-DevicePhilips Ultrasound, IncClass IIID2cwc Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- 2025-09-03FDA-DevicePhilips Ultrasound, IncClass IIIC9-5ec Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- 2025-09-03FDA-DevicePhilips Ultrasound, IncClass IIIC9-4v Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- 2025-09-03FDA-DevicePhilips Ultrasound, IncClass IIIC9-4 Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- 2025-09-03FDA-DevicePhilips Ultrasound, IncClass IIIC9-3v Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- 2025-09-03FDA-DevicePhilips Ultrasound, IncClass IIIC9-3io Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- 2025-09-03FDA-DevicePhilips Ultrasound, IncClass IIIC9-2 Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- 2025-09-03FDA-DevicePhilips Ultrasound, IncClass IIIC8-5 Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- 2025-09-03FDA-DevicePhilips Ultrasound, IncClass IIIC8-4v Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- 2025-09-03FDA-DevicePhilips Ultrasound, IncClass IIIC8-4v Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- 2025-09-03FDA-DevicePhilips Ultrasound, IncClass IIIC6-3 Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- 2025-09-03FDA-DevicePhilips Ultrasound, IncClass IIIC6-2 Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- 2025-09-03FDA-DevicePhilips Ultrasound, IncClass IIIC5-2 Lumify Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- 2025-09-03FDA-DevicePhilips Ultrasound, IncClass IIIC5-2 Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- 2025-09-03FDA-DevicePhilips Ultrasound, IncClass IIIc5-1 Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- 2025-09-03FDA-DevicePhilips Ultrasound, IncClass IIIC10-4ec Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- 2025-09-03FDA-DevicePhilips Ultrasound, IncClass IIIC10-3v Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- 2025-09-03FDA-DevicePhilips Ultrasound, IncClass IIIBP10-5ec Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- 2025-09-03FDA-DevicePhilips Ultrasound, IncClass III7.5MHZ Endo Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- 2025-09-03FDA-DevicePhilips Ultrasound, IncClass III3D9-3v Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- 2025-09-03FDA-DevicePhilips Ultrasound, IncClass III3D6-2 Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- 2025-09-03FDA-DeviceTandem Diabetes Care, Inc.Class IBattery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911; t:slim X2 GS Classic, Replacement, Refurbished, REF: 1003808; t: slim X2, Basal-IQ, mg/dl, REF: 1004219; Pump, t:slim X2, Clinical Use Only, REF: 1004484; Pump, t:slim X2, Control-IQ, REF: 1005611; Pump, t:slim X2, Control-IQ, mmoUL, Refurbished Replacement, REF: 1005613; Pump, t:slim X2, Control-IQ, mg/dl, REF: 1005615; Pump, t:slim X2, Control-IQ, mg/dl, Refurbished Replacement, REF: 1005617; Pump,
Insulin pumps manufactured with speakers from Revision A and B may malfunction ("Malfunction 16") which prevents audible alerts and causes the pumps to become inoperable and stop infusing insulin which could result in a hyperglycemic event, which may lead to injury and/or hospitalization.
- 2025-09-03FDA-DeviceGE Medical Systems, LLCClass IIGE HealthCare OEC 9900 Elite C-arm Systems.
GE HealthCare has become aware of a non-conformance to 21 CFR 1020.30 (k) in certain OEC 9800 and OEC 9900 Elite C-arm Systems. Specifically, impacted systems are missing the full layer of lead tape in the collimator covers, which will lead to a small increase in radiation exposure to the patient and/or operator. The missing lead tape is not detectable by the user.
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