cobas c513 Analyzer
Roche Diagnostics Operations
🏥 Medical Devices Class I - Dangerous
Quality issue with high pressure solenoid valves
All Recalls
95,038 total recalls in our database
Cobas 8000 Modular Analyzer Series: cobas 8000 ISE module part Numbers : 05964075001 cobas c 701 module part Numbers : 05641489001 cobas c 702 module part Numbers : 06473245001
Roche Diagnostics Operations
🏥 Medical Devices Class I - Dangerous
Quality issue with high pressure solenoid valves
🏥 Medical Devices Class I - Dangerous
Potential for the presence of two error codes which would make the monitor inoperable.
CE18TKN ACCU-BLOC PERIFIX KIT NRFIT Catalog # 339188
B. Braun Medical
🏥 Medical Devices Class I - Dangerous
The filter capacity is not achieved due to damage of the filter membrane.
CE17TKN CONT EPIDURALTUOHY NRFIT Catalog # 339183
B. Braun Medical
🏥 Medical Devices Class I - Dangerous
The filter capacity is not achieved due to damage of the filter membrane.
BD Kiestra InoqulA Software Version 20.3.IVD automated specimen processing Catalog Number: 447202
Becton Dickinson &
🏥 Medical Devices Class I - Dangerous
An anomaly is present in InoqulA / InoqulA+ software version 20.3, has the potential to cause a mismatch between a specimen and plate
The polarity of the output of power supply was reversed. Due to polarity of the output of power supplies being reversed, it renders the power supplies nonfunctional and the analyzer inoperable.
software error in the central control unit of the floor stand.
Integra Jarit GEMINI CLAMP 9 1/4 inch - used in vascular and cardiothoracic procedures used for clamping and occluding vessels. Cat. #140-332
Integra LifeSciences
🏥 Medical Devices Class I - Dangerous
A small crack at the box lock corner may after multiple cleaning and sterilization cycles produce an increased risk of corrosion, weakening the instrument and resulting in premature need for replacement and/or breakage of the instrument
AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff, 4.5 cm Part Number: 72400161
Boston Scientific
🏥 Medical Devices Class I - Dangerous
Mislabled: AMS 800 occlusive cuff labeled as 4.5 cm was a length of 4.0 cm and therefore..
Norm-O-Temp model 111Z
Cincinnati Sub-Zero Products LLC, a Gentherm Company
🏥 Medical Devices Class I - Dangerous
The manual does not provide instruction stating that exceeding 40 Celsius for extended periods can cause tissue damage.
Flexible Intubation Fiberscope, Model # 11301AB1
Karl Storz Endoscopy
🏥 Medical Devices Class I - Dangerous
The action is being initiated due to intubation scopes improperly manufactured with a double port luer instead of a single port luer.
OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component ApeX-LNK crosslinked Acetabular Insert, 10 deg hood; Product Code : H5-54840
OMNIlife science
🏥 Medical Devices Class I - Dangerous
Acetabular liners failed the oxidation testing performed prior to release. They may experience a higher wear rate, leading to revision surgery.
Fujifilm FDR Go Plus mobile X-ray system
Fujifilm Medical Systems U.S.A.
🏥 Medical Devices Class I - Dangerous
The graphics driver of the FDR Go PLUS might cause the appearance of a Blue Screen of Death (BSoD)
Norm-O-Temp model 111W
Cincinnati Sub-Zero Products LLC, a Gentherm Company
🏥 Medical Devices Class I - Dangerous
The manual does not provide instruction stating that exceeding 40 Celsius for extended periods can cause tissue damage.
🏥 Medical Devices Class I - Dangerous
Reversed expiration and manufacturing date on the label
CE18HKN ACCU-BLOC PERIFIX KIT NRFIT Catalog # 339189
B. Braun Medical
🏥 Medical Devices Class I - Dangerous
The filter capacity is not achieved due to damage of the filter membrane.
OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup Liner 53-28; Product code: H6-25328
OMNIlife science
🏥 Medical Devices Class I - Dangerous
Acetabular liners failed the oxidation testing performed prior to release. They may experience a higher wear rate, leading to revision surgery.
Alaris EtCO2, Model 8300, UDI: 10885403830013, CareFusion for models 11634567 and 8300ADXeN933
CareFusion 303
🏥 Medical Devices Class I - Dangerous
Calibration; it has been determined that the capnographs may have been calibrated during manufacturing using a lower than specified concentration of CO2
AngioDynamics VenaCure EVLT NeverTouch Procedure Kit, 45CM NEVERTOUCH FRS .018 PROCEDURE KIT PG, Catalog Number 11403012
Angiodynamics
🏥 Medical Devices Class I - Dangerous
The affected product is properly labelled with an expiration date of March 31, 2022; but the RFID programmed expiration date is April-2014 which results in an error message when connected to the laser source and prevents the product from being used.