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.
26,628 detailed records are currently available in this category.
A manufacturing defect on the amplifier board of the Flow Cytometers my cause signal loss and/or signal drifting resulting in absence of data or a population shift in the data plots. This…
Potential electric leakage affecting the user.
BD Vacutainer Urine Collection Cups may contribute to a slight elevation of Red Blood Cell (RBC) counts when used with the Sysmex UF Series Analyzers. BD recommends following Good Clinical…
Non-conformance with the DeltaVision OMX SR, the interlocks are not wired in a redundant fashion to make the interlock system single-fault tolerant.
There is an issue that could cause the Telligence System Gateway II, NGGTWY2 H, to stop communicating to the hallway devices connected to it. When this occurs, the dome lights connected to…
Potential electric leakage affecting the user.
Potential electric leakage affecting the user.
BD Vacutainer Urine Collection Cups may contribute to a slight elevation of Red Blood Cell (RBC) counts when used with the Sysmex UF Series Analyzers. BD recommends following Good Clinical…
There is a possibility that the liquid suction pump on some AIA-2000 analyzers may not perform as intended and cause an insufficient volume of wash solution to be removed during the washing…
Potential electric leakage affecting the user.
BD Vacutainer Urine Collection Cups may contribute to a slight elevation of Red Blood Cell (RBC) counts when used with the Sysmex UF Series Analyzers. BD recommends following Good Clinical…
Experienced accelerated battery depletion and a shortened replacement interval due to latent internal battery malfunctions.
In vitro diagnostic devices, used greater than 6 months after date of manufacture, may have increased concentration times of greater than the specification of 3 hours and up to 24 hours,…
A manufacturing defect on the amplifier board of the Flow Cytometers my cause signal loss and/or signal drifting resulting in absence of data or a population shift in the data plots. This…
VITROS Chemistry Products dLDL Reagent GENs 26 and 27, negatively biased results
A software issue may cause the liquid volume detection entries for 2nd and 3rd reagent bottles to be overwritten with the data from the 1st reagent bottle. Tosoh has released software…
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
After running the calibration curve, the recovery of the IgM kit control results decrease demonstrating a reduction in accuracy within the same day; control results may be out of range one…
Upgraded Aisys anesthesia devices and Aisys CS2 anesthesia devices with PSVPro Spontaneous Breathing Modes do not provide the PSVPro ventilation mode feature of transitioning to SIMV PCV…
The beds with the high rail side rail option may not be complaint with IEC 60601-2-52/C1:2010. There is a potential risk of entrapment.
The set screw is not able to advance or reverse from the original position in the nail.
Vibrations of the C-arm of the plane B may result in reduced image quality caused by the screw connection to the C-arm in the ceiling support
The set screw is not able to advance or reverse from the original position in the nail.
There is lot to lot variability for QC and patient results when using the identified reagent cartridge lots.
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.
