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Week of Jun 30, 2025

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Jul 3, 2025device recall406d agoOrascoptic Surgical Acuity device recall (Cls II)

Orascoptic Superior Visualization Phantom Nose Pad Accessory Kit ( nose pad and screw) 1 pk. and 20 pk. — Reason: Due to complaints, loupe nose pads containing nickel may cause an allergic reaction. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall406d agoPhilips Ultrasound, Inc device recall (Cls III)

L10-4LAP Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall406d agoPhilips Ultrasound, Inc device recall (Cls III)

C10-4ec Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall406d agoPhilips Ultrasound, Inc device recall (Cls III)

X5-1 Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall406d agoPhilips Ultrasound, Inc device recall (Cls III)

C8-4v Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall406d agoPhilips Ultrasound, Inc device recall (Cls III)

VL13-5 Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall406d agoPhilips Ultrasound, Inc device recall (Cls III)Ocuvex Therapeutics Inc

S4-1 Lumify Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall406d agoPhilips Ultrasound, Inc device recall (Cls III)

S4-2 Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall406d agoPhilips Ultrasound, Inc device recall (Cls III)

OMNI II TEE Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall406d agoPhilips Ultrasound, Inc device recall (Cls III)

C9-2 Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall406d agoPhilips Ultrasound, Inc device recall (Cls III)

3D9-3v Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall406d agoPhilips Ultrasound, Inc device recall (Cls III)

L18-5 Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall406d agoPhilips Ultrasound, Inc device recall (Cls III)

D2cwc Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall406d agoOrascoptic Surgical Acuity device recall (Cls II)

Orascoptic Superior Visualization Dragonfly Nose Pad Accessory Kit ( nose pad and screw) 1 pk and 20 pk. — Reason: Due to complaints, loupe nose pads containing nickel may cause an allergic reaction. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall406d agoPhilips Ultrasound, Inc device recall (Cls III)

mL26-8 Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall406d agoPhilips Ultrasound, Inc device recall (Cls III)

C6-3 Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall406d agoPhilips Ultrasound, Inc device recall (Cls III)

eL18-4 Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall406d agoPhilips Ultrasound, Inc device recall (Cls III)

mC12-3 Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall406d agoPhilips Ultrasound, Inc device recall (Cls III)

L15-7io Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall406d agoPhilips Ultrasound, Inc device recall (Cls III)

X5-1c Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall406d agoPhilips Ultrasound, Inc device recall (Cls III)Ocuvex Therapeutics Inc

L12-4 Lumify Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall406d agoPhilips Ultrasound, Inc device recall (Cls III)

S7-3t Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall406d agoPhilips Ultrasound, Inc device recall (Cls III)

S5-2 Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall406d agoPhilips Ultrasound, Inc device recall (Cls III)

3D6-2 Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall406d agoPhilips Ultrasound, Inc device recall (Cls III)

C9-4v Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall406d agoPhilips Ultrasound, Inc device recall (Cls III)

S3-1 Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall406d agoPhilips Ultrasound, Inc device recall (Cls III)

S8-3t Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall406d agoPhilips Ultrasound, Inc device recall (Cls III)

D5cwc Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall406d agoPhilips Ultrasound, Inc device recall (Cls III)

Transducer C10-3v Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall406d agoPhilips Ultrasound, Inc device recall (Cls III)

X11-4t Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall406d agoPhilips Ultrasound, Inc device recall (Cls III)

L12-3 Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall406d agoPhilips Ultrasound, Inc device recall (Cls III)

Mini Multi TEE Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall406d agoPhilips Ultrasound, Inc device recall (Cls III)

S4-1 Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall406d agoPhilips Ultrasound, Inc device recall (Cls III)

c5-1 Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall406d agoPhilips Ultrasound, Inc device recall (Cls III)

V6-2 Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall406d agoPhilips Ultrasound, Inc device recall (Cls III)

C9-4 Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall406d agoPhilips Ultrasound, Inc device recall (Cls III)

L12-5 50 Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall406d agoPhilips Ultrasound, Inc device recall (Cls III)

V9-2 Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall406d agoPhilips Ultrasound, Inc device recall (Cls III)

XL14-3 Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall406d agoPhilips Ultrasound, Inc device recall (Cls III)

X8-2t Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall406d agoPhilips Ultrasound, Inc device recall (Cls III)

C9-3io Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall406d agoPhilips Ultrasound, Inc device recall (Cls III)

L11-3 Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall406d agoPhilips Ultrasound, Inc device recall (Cls III)

OMNI III TEE Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall406d agoOrascoptic Surgical Acuity device recall (Cls II)

Orascoptic Superior Visualization Custom loupes with Dragonfly frames — Reason: Due to complaints, loupe nose pads containing nickel may cause an allergic reaction. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall406d agoPhilips Ultrasound, Inc device recall (Cls III)

D2TCD Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall406d agoPhilips Ultrasound, Inc device recall (Cls III)

C5-2 Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall406d agoPhilips Ultrasound, Inc device recall (Cls III)

L15-7IO TRANSDUCER Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall406d agoPhilips Ultrasound, Inc device recall (Cls III)

X7-2t Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall406d agoOrascoptic Surgical Acuity device recall (Cls II)

Orascoptic Superior Visualization Custom loupes configured with Phantom Frames — Reason: Due to complaints, loupe nose pads containing nickel may cause an allergic reaction. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall406d agoPhilips Ultrasound, Inc device recall (Cls III)

L17-5 Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

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