Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1,501–1,512 of 2,908 recalls
Due to a manufacturing issue, disinfecting cap for needle-free connectors may have an incomplete seal between the foil lid and plastic container, which may result in isopropyl alcohol evaporation from the sponge, which m…
Beckman Coulter has received complaints of erroneous Vitamin B12 results when using Access Vitamin B12 Reagent lot 439850.…
Eye syncing issues causing the device to be inoperable. Unable to be repaired due to discontinuation of support for the Pico 2 platform, which was no longer in production or serviceable as of August 31, 2023.
The remote interlock connector, which is required by 21 CFR 1040.10(f)(3), in the remote stop box was not installed the connector or was mechanically installed but not wired.…
The remote interlock connector, which is required by 21 CFR 1040.10(f)(3), in the remote stop box was not installed the connector or was mechanically installed but not wired.…
The remote interlock connector, which is required by 21 CFR 1040.10(f)(3), in the remote stop box was not installed the connector or was mechanically installed but not wired.…
Potential for faulty devices as a result of depleted batteries.
Certain Spectrum infusion pumps may have an incorrect version of software.
Certain Spectrum infusion pumps may have an incorrect version of software.
Due to the potential that some units within specific lots were damaged during the manufacturing process. The area of damage is within the same area of the lidding.…
Due to the potential that some units within specific lots were damaged during the manufacturing process. The area of damage is within the same area of the lidding.…
Due to the potential that some units within specific lots were damaged during the manufacturing process. The area of damage is within the same area of the lidding.…