All Recalls

95,114 total recalls in our database

ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

Siemens AG/Siemens Healthcare GmbH

🏥 Medical Devices Class I - Dangerous

A potential issue with ARTIS icono systems equipped with a small detector and a corresponding collimator (model # 10843101) was identified. In very rare situations, the first x-ray release following patient registration may be performed with incorrect copper prefiltration. If the described issue occurs, the applied radiation dose rate may be higher than intended by the user.

Jun 26, 2024 Diagnostic Equipment Nationwide View Details →

Sterile surgical convenience kit: Medline Retrograde PK-22025203-LF, Pack #DYNJ47873L, containing a Pure Pouch with component Sterile Curved Kelly Hemostat, Reorder #66175.

MEDLINE INDUSTRIES, LP - Northfield

🏥 Medical Devices Class I - Dangerous

Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails.

Mar 14, 2024 Surgical Instruments Nationwide View Details →

Brand Name: MEGADYNE" MEGA SOFT" Dual Reusable Patient Return Electrode Product Name: MEGADYNE" MEGA SOFT" Dual Reusable Patient Return Electrode Model/Catalog Number: 0835 Software Version: N/A Product Description: Reusable Patient Return Electrode, Mega Soft, Dual Cord, Adult, For Patients Weighing over 25lbs. (11.4kg), 117cm Long x 51cm Wide x 1.25cm Thick Component: No

Megadyne Medical Products

🏥 Medical Devices Class I - Dangerous

To limit the use of the Mega Soft Pads to patients aged 12 or older to mitigate the potential risk of patient burns identified with use of Mega Soft pads.

Jun 17, 2024 Other Medical Devices Nationwide View Details →

First Source iQ Flex M. Portable cart and platform that supports an X-ray system and laptop computer.

First Source

🏥 Medical Devices Class I - Dangerous

Potential for the bolt that secures the positioning arm to the gas spring to come loose and fall onto patient.

May 9, 2024 Other Medical Devices Nationwide View Details →

Prucka 3 Amplifier Model #P1801PA used with CardioLab AltiX electrophysiology recording system and ComboLab AltiX hemodynamic and electrophysiology recording system; and Field Replacement Units spare part #5875569 (Assy CLABIII AMP 128CH 100-240V 50-60HZ).

GE Medical Systems Information Technologies

🏥 Medical Devices Class I - Dangerous

Capacitors in certain Prucka 3 Amplifiers used with CardioLab / ComboLab systems could fail resulting in transient oscillations on the display and inability to view surface and intracardiac ECG waveforms.

Apr 22, 2024 Other Medical Devices Nationwide View Details →

Avalon Ultrasound Transducer. Directs low-energy ultrasound beam toward the fetal heart and externally monitors fetal heart rate.

Philips North America

🏥 Medical Devices Class I - Dangerous

Potential for inaccurate fetal heart rate measurements when monitoring multiples.

May 22, 2024 Diagnostic Equipment Nationwide View Details →

EVOLUTION¿ MP Femoral CS/CR Non-Porous Non-porous MicroPort total knee replacement implants are for cemented use only.

MicroPort Orthopedics

🏥 Medical Devices Class I - Dangerous

One confirmed incident has been received that EFSRN4PR, lot number MP1982170, Size 4 Evolution MP Non-Porous Femoral Right was opened during surgery and contained part number EFSRN3PL, lot number MP1982097, Size 3 Evolution MP Non-Porous Femoral Left in the packaging.

May 3, 2024 Implants & Prosthetics View Details →