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.
26,628 detailed records are currently available in this category.
Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product
Kit label states not made with natural rubber latex,however safety goggles within the kits contain natural rubber latex in the goggle strap
Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS Systems
If cables are improperly connected, current may reach high charge density, causing tissue harm.
Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS Systems
There were multiple issues identified in the system software which required an update.
Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product
There is a potential to generate falsely elevated serum or plasma chloride results when using the product.
Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS Systems
The application may be closed by the operating system without alerting the user the app is no longer running or communicating with the transmitter resulting in the user not receiving alerts…
Kit label states not made with natural rubber latex,however safety goggles within the kits contain natural rubber latex in the goggle strap
Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product
There were multiple issues identified in the system software which required an update.
Continuous operation at very high tube output may result in increased wear of the radiation emitting components. This may occur when tube voltages of 125 kV are used for a long period, e.g.…
There were multiple issues identified in the system software which required an update.
Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS Systems
Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product
There is no warning in the Elekta Unity manual for the administration of gadolinium-based or other contrast agents for imaging or image guidance purposes has not been validated.
There is a potential of fracture, bending or shearing of the driver.
Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to a software issue found in syngo CT VB10A for the Siemens Healthineers CT scanners with a…
hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations.
The firm has confirmed complaints regarding signal drops on the cobas e 801 module after a ProCell II M bottle changeover, which may lead to incorrect medical decisions with respect to…
Positive bias anti-thyroglobulin with ADVIA Centaur aTG kit lots ending in 316 and lower and Atellica IM aTG kit lots ending in 317 and lower when compared to the standardization to World…
During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss of one…
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.
