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.
26,155 detailed records are currently available in this category.
The priming volume values printed on the MAHURKA and Argyle acute catheters and Instructions for Use (IFU) are higher than the volumes required to fill each lumen.
New software version for affected ventilators reduces the probability of the ventilator entering an ambient state, in which the inspiratory channel and expiratory valves are opened, letting…
An incomplete occlusion can be caused by a variation in the wall thickness of the pumping segment of the affected infusion sets used with the. The issue has the potential to lead to…
The bedside panels and latch areas on the Giraffe Bedded Warmer and Panda iRes Warmer can crack or break if the unit is moved using the bedside panels instead of the front handle or the…
The bedside panels and latch areas on the Giraffe Bedded Warmer and Panda iRes Warmer can crack or break if the unit is moved using the bedside panels instead of the front handle or the…
The positive control on some tests of the lots did not appropriately react within the specified timeframe to verify the test was functioning correctly.
The product may not have met sterility requirements . Use of a non-sterile device on a patient may expose the patient to infectious agents.
E-Line Cutting Electrode package 8416.0305 contains E-Line Hook Electrode 8416.09 instead of E-Line Cutting Electrode 8416.03.
The positive control on some tests of the lots did not appropriately react within the specified timeframe to verify the test was functioning correctly.
The potential sporadic performance problems may result in scanning workflow interruptions and unexpected user notifications. This may cause a delay in diagnosis or patient scans.
There is a potential presence of ruptured dialyzer fibers which may lead to a blood leak during treatment.
There is a potential for weak seals of the sterile packaging.
The potential sporadic performance problems may cause scanning workflow interruptions and unexpected user notifications resulting in diagnostic delay or need for patient rescan.
A steady upward trend in blank (u) absorbance was observed
There is a potential for weak seals of the sterile packaging.
The 0-arm 1000 Imaging System uses energy from the batteries to generate X-rays and move the system. If a charger board is not functioning properly, the batteries will not receive a full…
There is a potential for weak seals of the sterile packaging.
There is a potential for the device to fail to deliver energy to the patient.
Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot…
The potential sporadic performance problems may cause scanning workflow interruptions and unexpected user notifications resulting in diagnostic delay or need for patient rescan.
Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot…
When calculating electron Monte Carlo dose with a very large number of histories, the dose calculation may be wrong
Falsely elevated (false positive) urobilinogen patient results due to an increase in the sensitivity of the urobilinogen reaction.
User-induced circumstances can contribute to the EVOLIS Microplate Processor System not handling repeat testing requests/results properly and may contribute to transmitting erroneous…
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.
