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.
Potential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant balloon dilatation (PID).
Products do not meet stability criteria and may impact results.
All-in-One Tab Removal Tool may cause cracking and/or separating at the threaded interface between tool s metal shaft component and handle, resulting in leakage of Loctite from handle cracks
Products do not meet stability criteria and may impact results.
The firm has identified a problem with the control software for the celling arm of the X-Ray System . This software issue could cause the ceiling arm of the device to move after the…
There is a potential that the adjustable handle option on the X-Ray system may have been installed with improper bolts. This could result in improper driving operation which could lead to…
Potential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant balloon dilatation (PID).
The radio within the device can become disassociated with the wireless access point.
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During internal testing, it was found that upon a device reset, the Generator exhibits the incorrect Model Number when interrogated.
The firm has identified a problem with the control software for the celling arm of the X-Ray System . This software issue could cause the ceiling arm of the device to move after the…
Speakers on IntelliVue X2 and IntelliVue MP2 may fail, identified by the display of a Speaker Malfunct. INOP or by the absence of audible sound, may result in delayed treatment of the…
Failing to meet the linearity performance claims quoted on the kit inserts-The linearity is reduced by approximately -30% for Serum/ Plasma and -50% for Urine
Recent product complaints showing an unexpected cell population exhibiting dim CD3 expression that may result in inaccurate results gating.
The firm has identified a problem with the control software for the celling arm of the X-Ray System . This software issue could cause the ceiling arm of the device to move after the…
Possible false negative or false positive results. The incorrect sample collection swabs (non-scored) were assembled into assembled into the in vitro diagnostic kits. If the user does not…
Dimensions of the Luer connector parts out of specification, may cause leakage of fluid and unintended disconnection during use
Dimensions of the Luer connector parts out of specification, may cause leakage of fluid and unintended disconnection during use
A software problem has been identified which could result in the CT Scanner not proceeding to the next actual scan even though automatic start of the next scan is specified. This could…
Potential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant balloon dilatation (PID).
Speakers on IntelliVue X2 and IntelliVue MP2 may fail, identified by the display of a Speaker Malfunct. INOP or by the absence of audible sound, may result in delayed treatment of the…
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Failing to meet the linearity performance claims quoted on the kit inserts-The linearity is reduced by approximately -30% for Serum/ Plasma and -50% for Urine
During system upgrade incorrect comments may be added to existing tests. In such instance: Resting ECG and ABP tests which did not contain comments at the time of the upgrade, may have…
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.
