Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1,969–1,980 of 2,908 recalls
The mounting hardware that is supplied with the 4FXS-60 monitor bracket does not provide adequate thread engagement to support the weight of the frame and monitor.…
Unintended motion issues related to Interventional Control that may lead to collision of the Gantry/table with the operator or patient.
ABL90 FLEX and ABL90 FLEX PLUS analyzers running with Radiometer Windows 10 versions RWIN10 1.0 and RWIN10 1.1 may unexpectedly freeze (the analyzer ceases to operate) during a sample measurement.…
Due to product outer packaging incorrectly labeled.
Devices for the affected lot were not assembled according to product specifications. The distraction rod outer diameter was assembled with a 5.5mm rod versus the required 5.0mm.
When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used.…
When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used.…
When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used.…
When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used.…
When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used.…
A specific lot of Latitude Humeral Trial Stems has the incorrect direct part marking. " Laser Marked: 9030103, Humeral Stem Trial 150mm Large / Right, Yellow color indicator (incorrect) " Device Actually: 9030092, Hume…
Insulin pens may have been incorrectly assembled therefore users could experience the following: either the insulin cartridge will not fit into the cartridge holder;…