🏥 Medical Devices Class I - Dangerous
Table may drift in the roll position while in use
All Recalls
95,064 total recalls in our database
🏥 Medical Devices Class I - Dangerous
Instead of having a spherical diameter, the probe was observed to have 2 radii and a flat surface. Additionally, upon further investigation, it was observed that some parts exhibited an edge on the intersection between the radius and the diameter of the probe.
🏥 Medical Devices Class I - Dangerous
Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent.
🏥 Medical Devices Class I - Dangerous
The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient.
Xper Flex Cardio Physiomonitoring System, Software versions 1.5.16.0322 and 1.6.1.0390, Model Numbers 453564241901, 453564241911, 453564483321, 453564483331, 453564621791, 453564621801, 453564669081
Philips Electronics North America
🏥 Medical Devices Class I - Dangerous
There are 3 issues: 1) Under certain conditions, real time waveforms may not be accurately plotted or displayed. 2) The oxygen saturation (SpO2) numeric value displayed on the device may freeze. 3) In auto cycle mode, if the NIBP communication is lost, the pump would not cycle and the non-invasive blood pressure (NIBP) numeric value displayed on the device would not update.
Correction to update the surgical technique for the Compress System. To make users aware of the changes that were made only to the selection criteria section on page 42 regarding which array to use in the placement of the anti-rotation pins.
🏥 Medical Devices Class I - Dangerous
Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent.
🏥 Medical Devices Class I - Dangerous
There have been reports of shortened (T1-T2) results, where some instances of result recovery outside of the range of less than or equal to 15 seconds.
🏥 Medical Devices Class I - Dangerous
There have been reports of distal occlusion alarms during the use of SAPPHIRE Epidural Set Yellow-Striped administration sets.
Genesys 2 Reagent, REF 01-03-0022 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only.
Clark Laboratories, Inc. (dba,Trinity Biotech USA)
🏥 Medical Devices Class I - Dangerous
lack of 510K
🏥 Medical Devices Class I - Dangerous
Insufficient seal on the sterile barrier of the device, compromising the sterility of the device
Genesys Analytical Column, REF 01-05-0017 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only.
Clark Laboratories, Inc. (dba,Trinity Biotech USA)
🏥 Medical Devices Class I - Dangerous
lack of 510K
🏥 Medical Devices Class I - Dangerous
Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging) of the Protexis Neoprene surgical gloves are incorrect. Additionally, breakthrough times for Mitomycin were added to the same label in error.
🏥 Medical Devices Class I - Dangerous
There is a potential for the male connectors on external cables to become damaged. This could include a detached male connector housing, misaligned connector, cracked connector housing, and bent pins.
🏥 Medical Devices Class I - Dangerous
The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient.
🏥 Medical Devices Class I - Dangerous
Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging) of the Protexis Neoprene surgical gloves are incorrect. Additionally, breakthrough times for Mitomycin were added to the same label in error.
🏥 Medical Devices Class I - Dangerous
Some of the pouches containing Brachytherapy Applicator Needles (18g x 20cm) were not sealed
🏥 Medical Devices Class I - Dangerous
Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging) of the Protexis Neoprene surgical gloves are incorrect. Additionally, breakthrough times for Mitomycin were added to the same label in error.
🏥 Medical Devices Class I - Dangerous
The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient.
FoundationOne CDx Test Results
Foundation Medicine
🏥 Medical Devices Class I - Dangerous
An incorrect test result for a single analyte may have been reported for up to 800 physician reports