Monitor U.S. medical device recall enforcement reports from the FDA. Review product descriptions, recall reasons, classifications, dates, recalling firms and distribution information where the FDA provides them.
25,099 detailed records are currently available in this category.
Siemens has become aware of a hardware error which affects Cios Spin and Cios Alpha systems after the previous repair of the X-ray Generator with an integrated Energy Storage Unit (ESU).
The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften over time so that it may be more susceptible to damage by scratching or bending,…
During a procedure, when images were acquired, and these images were transferred to PACS /image archival system, the number of images displayed were not the same as originally acquired.
Reports that manipulation of the cable which connects the pre-amplifier to the nerve monitor, and the cable which connects the pre-amplifier to the stimulator pod, may cause damage to the…
The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften over time so that it may be more susceptible to damage by scratching or bending,…
Potential Endotoxin Contamination
Potential Endotoxin Contamination
Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS XT TBIL-ALKP Slides
Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used on certain reusable flexible…
Incorrect lot number for Standard Oral Fluid Negative Calibrator on specification sheet included in kit and/or additionally same error on unit box
The procedure side indicated in the top header of the Shoulder Case Planning Report incorrectly indicated the procedure side as "Left" for surgical plans for a "right" procedure side.
Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used on certain reusable flexible…
The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften over time so that it may be more susceptible to damage by scratching or bending,…
Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used on certain reusable flexible…
The oxygen sensor for certain CARESCAPE R860 devices has a potential issue that may result in an inaccurate display of FiO2 value from what is being delivered.
Potential Endotoxin Contamination
Potential Endotoxin Contamination
The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften over time so that it may be more susceptible to damage by scratching or bending,…
Mislabeled outer carton: packaged with the outer carton label stating the contents were the 70143662 Smart Piston but the inside package contents was the 70142158 Stapes Piston; see image…
In affected software version, of Positron emission tomography and computed tomography system, the CT Hounsfield unit curve may not display in real time when using the bolus tracking…
LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim.
While operating the machine in "Run" mode an unexcepted event may occur during the error-checking for stepper movements and pressure values. The result of this event is a false alarm being…
A problem has been detected with the Philips LI-Polymer rechargeable battery when used with its approved charging station and module charger. When the battery is inserted into a charger…
Multiple lots being recalled due to a product design issue
Medical device recall records can change as the FDA receives additional information. Check the official record identifier and current FDA information before making health or product-use decisions.
Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.
This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.
