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.
24,239 detailed records are currently available in this category.
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.
Due to misbranded products shipped to customers.
The labeling was missing information on sterilization and prohibition of reuse.
Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.
Due to misbranded products shipped to customers.
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.
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…
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…
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.
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…
Due to unapproved raw materials used in the manufacturing of Covid-19 control pack, their is the potential for delayed amplification signals.
Product has a lack of sterility assurance
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.
Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.
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…
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.
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.
