🏥 Medical Devices Class I - Dangerous
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
All Recalls
95,025 total recalls in our database
🏥 Medical Devices Class I - Dangerous
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128
Thera Test Laboratories
🏥 Medical Devices Class I - Dangerous
The cross-reactivity of the device may present an increased level of potential false positives. Submitted as EUA202128
EL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129
Thera Test Laboratories
🏥 Medical Devices Class I - Dangerous
Device did not meet the updated EUA packet requirements for positive percent agreement, thus, not adequately validated. Submitted as EUA202129
🏥 Medical Devices Class I - Dangerous
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
🏥 Medical Devices Class I - Dangerous
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
Merge Hemo, Software packages 10.2, 10.3, and 10.4
Merge Healthcare
🏥 Medical Devices Class I - Dangerous
The firm identified a safety issue affecting the software associated with Merge Hemo versions 9.x and 10.x, used in combination with an HL7 lab interface.
🏥 Medical Devices Class I - Dangerous
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
🏥 Medical Devices Class I - Dangerous
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
Lase DiscectomLase Discectomy Device Kit, Models 1100-002 and 1100-002 SHORTy Device Kit, Models 1100-002
Clarus Medical
🏥 Medical Devices Class I - Dangerous
The sterile barrier seal may be compromised.
🏥 Medical Devices Class I - Dangerous
Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and ankle may not be aligned, causing the anatomic landmark locations to potentially result in limb malalignment.
🏥 Medical Devices Class I - Dangerous
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
🏥 Medical Devices Class I - Dangerous
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
🏥 Medical Devices Class I - Dangerous
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
CombiDiagnost R90 Software Version R1.0 and R1.1
Philips Medical Systems Gmbh, DMC
🏥 Medical Devices Class I - Dangerous
Philips has become aware of a software issue, where the kV and mA values are not locked immediately but change when the collimator shutter position is changed directly after the Lock-In command. This software issue leads to an over or under exposed image.
🏥 Medical Devices Class I - Dangerous
Products labeled as sterile were distributed, but may not have been sterilized. " Baxter confirmed Steril Milano observed nonconformances that were not reported to Baxter. Data was manipulated to appear to be conforming
Products may have been distributed to customers other than laboratories certified under the Clinical Laboratory Improvement Amendments as stipulated in the Emergency Use Authorization.
🏥 Medical Devices Class I - Dangerous
Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and ankle may not be aligned, causing the anatomic landmark locations to potentially result in limb malalignment.
🏥 Medical Devices Class I - Dangerous
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
smiths medical portex Tracheal Intubation Stylet, REF 100/120/200, 4.0mm OD X 335mm, 10/box, sterile.
Smiths Medical ASD
🏥 Medical Devices Class I - Dangerous
The incorrect device is contained in the package.