🏥 Medical Devices Class I - Dangerous
Use of the product may not provide adequate recovery and could result in false negative identification of Legionella pneumophila.
All Recalls
95,114 total recalls in our database
ADVIA Centaur Systems Progesterone Kit, (5 -pack); In Vitro Diagnostic; Catalog number: 01586287; SMN:10315522.
Siemens Healthcare Diagnostics
🏥 Medical Devices Class I - Dangerous
ADVIA Centaur Systems Progesterone Kit Lots Ending in 268 have a high bias on results greater than 30 ng/mL (95.4 nmol/L)
🏥 Medical Devices Class I - Dangerous
A device malfunction may cause the biopsy needle to fail to reach the intended target. If location confirming radiographs are not taken and properly evaluated, biopsy site mislocation can result in non-target tissue being sampled rather than target tissue. May result in an incorrect diagnosis.
🏥 Medical Devices Class I - Dangerous
Defect: A hole or crack was found which may cause air to leak.
Ikaria, INOmax DSIR (Delivery System), Model 10007. Nitric oxide delivery system for use with ventilators.
INO Therapeutics (dba Ikaria)
🏥 Medical Devices Class I - Dangerous
Potential delivery failure alarm condition. INOmax DSIR with software version 2.0.4 and a certain variant of the monitor display may trigger a delivery failure alarm when the display brightness is set to its lowest level. If this condition occurs, therapy will be interrupted.
Philips Medical System Allura Xper X-Ray Angiographic
Philips Medical Systems
🏥 Medical Devices Class I - Dangerous
In certain circumstances, a software error can lead to a situation where the five minute fluoroscopy audible signal does not sound.
🏥 Medical Devices Class I - Dangerous
Outer package product label incorrectly identifies the product as FiberOptix Flex IAB 7.5Fr rather than the correct FiberOptix IAB 8Fr
The I-Cart is used to store, transport, and power video equipment used in medical procedures.
Richard Wolf Medical Instruments
🏥 Medical Devices Class I - Dangerous
The transformers installed on carts used for Richard Wolf medical video systems may overheat causing smoke and black plastic material to leak from the cart chassis.
Xoran MiniCAT X-ray imaging device
Xoran Technologies
🏥 Medical Devices Class I - Dangerous
Out of tolerance kVp, Unexposed (black) frames, and Out of tolerance Dose.
Servo-I ventilator system CO2 analyzer. Part number 65 23 588.
Maquet Cardiovascular Us Sales
🏥 Medical Devices Class I - Dangerous
A calibration problem was detected in a specific number of the Servo-I ventilator system CO2 analyzer models that may have been caused by the module's internal circuit board function.
🏥 Medical Devices Class I - Dangerous
Self-Righting Luer Tip Caps were manufactured and shipped with a missing latex symbol on both single and case labels.
🏥 Medical Devices Class I - Dangerous
Incorrect CT to ED when using the Monaco Image Statistics Tool.
🏥 Medical Devices Class I - Dangerous
Incorrect size printed on the Milex Pessary Kit packaging label
Reports of formation of char adherent to the proximal part of the distal tip electrodes
LFT v40 Femoral Head; Catalog Number 6260-9-032; V40 CoCr LFit Head 32mm/-4. Designed to be assembled onto a femoral hip stem trunnion during surgery for a total hip arthroplasty.
Stryker Howmedica Osteonics
🏥 Medical Devices Class I - Dangerous
Three customer complaints were received for the same batch of V40 LFIT Vitallium femoral heads (part number 6260-9-032, lot 48681201) alleging that the femoral head couldn't be assembled with its corresponding V40 stem trunnion.
🏥 Medical Devices Class I - Dangerous
PMMA coating does not meet specifications. Area of the stem may be missing PMMA coating.
🏥 Medical Devices Class I - Dangerous
The manufacturers seal may not be present on the Nylon pouch resulting in lack of assurance for sterility.
🏥 Medical Devices Class I - Dangerous
The manufacturers seal may not be present on the Nylon pouch resulting in lack of assurance for sterility.
RotoRest Delta Advanced Therapy System. The RotoRest Delta Advanced Kinetic Therapy System offers kinetic therapy for the most aggressive treatment of pulmonary complications.
Arjo Hospital Equipment AB
🏥 Medical Devices Class I - Dangerous
The recalled devices labeling and instructions for use contain unapproved medical claims.
Rotoprone Therapy System. The Rotoprone Therapy System is an advanced patient care system for the treatment and prevention of pulmonary complications.
Arjo Hospital Equipment AB
🏥 Medical Devices Class I - Dangerous
The recalled devices labeling and instructions for use contain unapproved medical claims.