Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1,897–1,908 of 2,908 recalls
The frequency inverter is not programmed by supplier according to specification which causes the circulation pump to start earlier than expected, resulting in additional wear and tear, earlier than expected, on the axial…
The frequency inverter is not programmed by supplier according to specification which causes the circulation pump to start earlier than expected, resulting in additional wear and tear, earlier than expected, on the axial…
A single lot of the ImmunoCard STAT! Crypto/Giardia Test Kit was inadvertently stored in Medline warehouses at temperatures outside of the labeled storage requirements.
Vials of implant bone granules may contain less product then specified on labeling.
Inadequate weld that can potentially cause the product to disassemble.
Inadequate weld that can potentially cause the product to disassemble.
There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.
There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.
In response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjunction with implantation of enVista Aspire and enVista Envy IOLs, and certain enVista monofocal lenses in the U.S.
In response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjunction with implantation of enVista Aspire and enVista Envy IOLs, and certain enVista monofocal lenses in the U.S.
Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.
Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.