FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 141–160 of 396 recalls

Class IICompleted

ARIA Radiation Therapy Management (RTM) VERSIONS 13.6, 15.1, 15.5, 15.6, 16.0, 16.1

Varian Medical Systems Imaging Laboratory GmbH

Software issue for treatment plan and image management application may result in mismatch values which could result in treatment in the wrong location

March 21, 2022 · DeviceView details →

Class IICompleted

Cardinal Health PROTEXIS PI and PI Classic, Surgical Gloves

Cardinal Health 200, LLC

Product was distributed without being sterilized.

March 15, 2022 · DeviceView details →

Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) WC77V; 2) WC77V-DEMO; 3) WC77V-R; used in conjunction with Warming Blankets and Mattresses, veterinary use.

HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error code "EA POST".

FDA Device Recalls

ARIA Radiation Therapy Management (RTM) VERSIONS 13.6, 15.1, 15.5, 15.6, 16.0, 16.1

Cardinal Health PROTEXIS PI and PI Classic, Surgical Gloves

Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) WC77V; 2) WC77V-DEMO; 3) WC77V-R; used in conjunction with Warming Blankets and Mattresses, veterinary use.

Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC71, 2) Model # WC71R (refurbished); used in conjunction with Warming Blankets and Mattresses.

Hillrom Temperature Management Controller, MP, Model # 2083516; used in conjunction with Warming Blankets and Mattresses.

Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC77, 2) Model # WC77D (Demo), 3) Model # WC77R (Refurbished); used in conjunction with Warming Blankets and Mattresses.

Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) WC71V; 2) WC71V-DEMO; 3) WC71V-R; used in conjunction with Warming Blankets and Mattresses, veterinary use.

4.0mm x 10mm Cannulated Screw, Short Thread; Part number 3005-40010

4.0mm x 12mm Cannulated Screw, Short Thread; Part number 3005-40012

Outer Packaging Label: Protekt Sharps Safety Knives - REF: PG 44620MU, Sterile R, Multi-Use 2.2mm Double Bevel Slit, Angled 6 units, Individual Packaging Label: ProTekt Sharps Safety Knives - REF: PG 44620MU,2.2mm double Bevel Slit, Sterile R, Angled 1 unit, Handle Labeling; 2.5mm slit double bevel

iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101

Illumina NextSeq 550Dx, REF: 20005715, CE, IVD

Destino Twist 14F (also branded as Guidestar 14F)

ComposiTCP 30 Interference screw D 7- L:25 mm, REF 110004605

Ingenia 1.5T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781261 781262

Ingenia Ambition X- Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781356

Ingenia 1.5T- a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781341 781396

Ingenia 3.0T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781271

Ingenia Elition X-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781358