Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 541–552 of 816 recalls
Devices had an unapproved slabbing software function enabled for use.
SwabFlush syringes are affected by the ICU Medical recall of their SwabCap Disinfecting Cap due to a manufacturing issue which affects the seal between the foil lid and plastic container of the Swab Cap.…
Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both.
Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both.
The DFPM yoke assembly ("yoke assembly") may detach from the spring arm. Should the yoke assembly detach from the spring arm, the yoke assembly would not be expected to fully detach but rather hang from the wiring within…
The DFPM yoke assembly ("yoke assembly") may detach from the spring arm. Should the yoke assembly detach from the spring arm, the yoke assembly would not be expected to fully detach but rather hang from the wiring within…
Ventilator coaxial breathing circuit may have a crack in blue tubing, which is used to deliver fresh gas to the patient. The crack will compromise inspiratory and expiratory flows, leading to partial or complete rebreath…
Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
The firm issued a field safety notice after becoming aware of three lots of products not having quarterly dose audits being completed on time in the first quarter of 2024.…