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calendar

363 catalysts · 16,384 approval · 2,962 device 510k · 592 device pma · 575 recall · 363 device recall

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type: device recall×to 2025-08-21×clear all

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approval16,384
device 510k2,962
device pma592
recall575
device recall363

therapy area

no tagged catalysts yet

Week of Jun 30, 2025

50

›Jul 2, 2025device recall405d agoGE Medical Systems, LLC device recall (Cls II)

GE HealthCare OEC 9900 Elite C-arm Systems. — Reason: 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. — Status: Ongoing

full page →fda device recalls ↗

›Jul 2, 2025device recall405d agoGE Medical Systems, LLC device recall (Cls II)

GE HealthCare OEC 9800. — Reason: 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. — Status: Ongoing

full page →fda device recalls ↗

›Jul 2, 2025device recall405d agoSpark Biomedical Inc device recall (Cls II)IMPACT BIOMEDICAL INC.

Sparrow Ascent Patient Controller, REF's: 11-110-K, 11-310-K, 11-320-K, 11-321-K, 11-310-K-28, 11-320-K-28, 11-321-K-28 — Reason: Due to manufacturing issue, neurostimulator device may experience "cable disconnect" error message and interruption to stimulation output. — Status: Ongoing

full page →fda device recalls ↗

›Jul 3, 2025device recall404d agoPhilips Ultrasound, Inc device recall (Cls III)

TRANSDUCER L12-5 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 recall404d agoOrascoptic Surgical Acuity device recall (Cls II)

Orascoptic Superior Visualization Dragonfly Essentials Kit ( Nose pad, a screw, lens cleaning wipe, side shields, head strap, and a screwdriver) — Reason: Due to complaints, loupe nose pads containing nickel may cause an allergic reaction. — Status: Ongoing

full page →fda device recalls ↗

›Jul 3, 2025device recall404d agoPhilips Ultrasound, Inc device recall (Cls III)

C6-2 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 recall404d agoPhilips Ultrasound, Inc device recall (Cls III)

L12-5 38mm 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 recall404d 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 recall404d 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 recall404d 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 recall404d 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 recall404d 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 recall404d 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 recall404d 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 recall404d 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 recall404d 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 recall404d 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 recall404d 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 recall404d 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 recall404d 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 recall404d 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 recall404d 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 recall404d 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 recall404d 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 recall404d 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 recall404d 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 recall404d 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 recall404d 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 recall404d 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 recall404d 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 recall404d 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 recall404d 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 recall404d 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 recall404d 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 recall404d 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 recall404d 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 recall404d 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 recall404d 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 recall404d 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 recall404d 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 recall404d 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 recall404d 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 recall404d 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 recall404d 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 recall404d 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 recall404d 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 recall404d 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 recall404d 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 recall404d 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 recall404d 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 ↗

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