Complete FDA and NHTSA recall records dated in 2021, organized for browsing by month, category and recalling company.
Select a month to review the recall records reported during that period.
Records are ordered by the best available source date.
The rear heater plate and cover assembly that contains the electrical wiring for the heaters does not have sufficient bonding to ground.
There was an increase in complaints related to tip breaks and wobble/vibration.
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrument Stability from 7 days to 5 days
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls Outside of Expected Control Range, potential for delayed results
Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.
Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.
There is a potential that the length of bone screws identified on labeling may not correspond to the actual length of the screw included.
There was an increase in complaints related to tip breaks and wobble/vibration.
Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrument Stability from 7 days to 5 days
There was an increase in complaints related to tip breaks and wobble/vibration.
Ancillary reagent packs used on Atellica IM 1300 and Atellica IM 1600 analyzers may overflow when pierced while on an analyzer located at an altitude of greater than 350m (1148ft) above sea…
Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
Product has a lack of sterility assurance
Due to unapproved raw materials used in the manufacturing of Covid-19 control pack, their is the potential for delayed amplification signals.
Ultrasound system software issue can cause an EchoNavigator error notification, leading to an unresponsive system, necessitating system restart, which could lead to therapy/treatment delay…
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
A software problem has been identified which could result in the diagnostic imaging system not proceeding to the next actual scan even though automatic start of the next scan is specified.…
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
Ancillary reagent packs used on Atellica IM 1300 and Atellica IM 1600 analyzers may overflow when pierced while on an analyzer located at an altitude of greater than 350m (1148ft) above sea…
A Cardiosave Lithium-Ion Battery Pack used during protocol testing failed to meet the minimum runtime requirement per Getinge internal Product Specification. These nonconforming batteries…
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.
