Complete FDA and NHTSA recall records dated in December 2020.
These records include useful source details for the selected month.
Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
General Motors, LLC (GM) is recalling certain 2020 Chevrolet Bolt EV and 2021 GMC Canyon and Sierra 1500, 2500 and 3500, Yukon, Yukon XL, Cadillac Escalade and Escalade ESV and Chevrolet…
Ford Motor Company (Ford) is recalling certain 2020-2021 Explorer and Lincoln Aviator vehicles. The right hand motor mount fasteners may have been incorrectly tightened, and may loosen over…
General Motors, LLC (GM) is recalling certain 2019-2021 Chevrolet Silverado 1500 and GMC Sierra 1500, 2021 Chevrolet Suburban and Tahoe and GMC Yukon XL and 2020-2021 Chevrolet Silverado…
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…
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
XXX
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…
Potential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant balloon dilatation (PID).
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…
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
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…
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…
Recent product complaints showing an unexpected cell population exhibiting dim CD3 expression that may result in inaccurate results gating.
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
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…
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…
During internal testing, it was found that upon a device reset, the Generator exhibits the incorrect Model Number when interrogated.
XXX
The radio within the device can become disassociated with the wireless access point.
Potential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant balloon dilatation (PID).
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…
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…
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.
