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.
Due to two (2) issues: 1) The firm distributed COVID-19 Rapid Test Cassettes outside of the Emergency Use Authorization to non-certified Clinical Laboratories. 2) COVID-19 Rapid Test…
There is the potential of a bent or disconnected needle in one of the components of the convenience kits.
GE Healthcare has become aware of a potential issue on Revolution Apex, Revolution CT with Apex Edition, Revolution CT, and Revolution CT ES systems where the table pinch protector could be…
Potential for false negative diagnosis of gastroparesis. Certain GEBT kits containing 13C-Spirulina elicit unusually high 13CO2-excretion rates
There is the potential of a bent or disconnected needle in one of the components of the convenience kits.
complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.
Potential for variation in radiopaque marking visibility under radiographic imaging for adjustable and fixed-pressure valves that are used in the management of hydrocephalus
Device requires the use of an Isolation Transformer in combination with the SDM in home care settings to comply with applicable safety standards.
complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.
complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.
complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.
Observations of potential false positive results in the specified lots. Use of these test strips may result in false positive patient test results and potential exposure to unnecessary…
Potential for variation in radiopaque marking visibility under radiographic imaging for adjustable and fixed-pressure valves that are used in the management of hydrocephalus
Potential for variation in radiopaque marking visibility under radiographic imaging for adjustable and fixed-pressure valves that are used in the management of hydrocephalus
When using software 1.90.2.09 or 1.90.8.06 and using modality worklist functionality for patient data transfer, the selection of the patient in the patient list may not match the patient…
complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.
GE Healthcare has become aware of a potential issue on Revolution Apex, Revolution CT with Apex Edition, Revolution CT, and Revolution CT ES systems where the table pinch protector could be…
There is the potential of a bent or disconnected needle in one of the components of the convenience kits.
Distributed COVID test kits without emergency use authorization.
complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.
The potential that the plastic inlet hose connections may deform or break as a result of material fatigue and/or over tightening of the clamps. A broken hose connection may lead to a…
There is the potential of a bent or disconnected needle in one of the components of the convenience kits.
Ingredients were not pasteurized after blending as required by State of Wisconsin.
Ingredients were not pasteurized after blending as required by State of Wisconsin.
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.
