Calendar

Week of Jun 30, 2025

Jul 3, 2025device recall407d 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 recall407d agoPhilips Ultrasound, Inc device recall (Cls III)

L9-3 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 recall407d agoPhilips Ultrasound, Inc device recall (Cls III)

X7-2 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 recall407d agoTandem Diabetes Care, Inc. device recall (Cls II)TANDEM DIABETES CARE INC

t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app) — Reason: an app defect that occurs when the phone is set to a right-to-left language, which causes app-pump pairing issues and graphical defects, which can potentially lead to incorrect therapy decisions and subsequent hypoglycemia or hyperglycemia. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall407d agoPhilips Ultrasound, Inc device recall (Cls III)

S9-2 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 recall407d agoPhilips Ultrasound, Inc device recall (Cls III)

C8-5 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 recall407d agoPhilips Ultrasound, Inc device recall (Cls III)

mC7-2 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 recall407d agoPhilips Ultrasound, Inc device recall (Cls III)Ocuvex Therapeutics Inc

C5-2 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 recall407d agoPhilips Ultrasound, Inc device recall (Cls III)

X6-1 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 recall407d agoPhilips Ultrasound, Inc device recall (Cls III)

C9-3v 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 recall407d agoPhilips Ultrasound, Inc device recall (Cls III)

L12-4 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 recall407d agoPhilips Ultrasound, Inc device recall (Cls III)

BP10-5ec 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 recall407d agoPhilips Ultrasound, Inc device recall (Cls III)

SCNHD LA L7-4 HDI 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 recall407d agoPhilips Ultrasound, Inc device recall (Cls III)

L8-4 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 recall407d agoPhilips Ultrasound, Inc device recall (Cls III)

7.5MHZ Endo 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 recall407d 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 recall407d 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 recall407d 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 recall407d 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 recall407d 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 recall407d 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 recall407d 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 recall407d 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 recall407d 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 recall407d 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 recall407d 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 recall407d 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 recall407d 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 recall407d 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 recall407d 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 recall407d 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 recall407d 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 recall407d 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 recall407d 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 recall407d 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 recall407d 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 recall407d 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 recall407d 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 recall407d 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 recall407d 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 recall407d 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 recall407d 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 recall407d 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 recall407d 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 recall407d 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 recall407d 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 recall407d 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 recall407d 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 recall407d 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 recall407d 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 ↗

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Week of Jun 30, 2025