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.
Misaligned placement of an axis mark can cause the patient to experience blurred vision
Misaligned placement of an axis mark can cause the patient to experience blurred vision
Misaligned placement of an axis mark can cause the patient to experience blurred vision
Latch mechanism on the Lift-Off foot section of the Affinity Four Birthing Bed is damaged, it could potentially cause the installed foot section to be improperly engaged onto the bed, could…
Potential for oxygen tubing to disconnect from mask or loosen. Disconnected tubing results in a loss of device function and use of the device could result in inappropriate or a lack of…
The seating system unexpectedly detached, which resulted in the seating system falling to the ground, causing injury.
The device may show unexpected locus specific signals in addition to those at 22q. Users may observe faint additional locus specific signals at 20p12/13.
Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized
Misaligned placement of an axis mark can cause the patient to experience blurred vision
Initial delivery positions will be set incorrectly when having setup beam(s) at the localization point.
Misaligned placement of an axis mark can cause the patient to experience blurred vision
During product complaint investigation, it was determined that during stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of the graft cover.
Misaligned placement of an axis mark can cause the patient to experience blurred vision
Due to a design issue, inflation syringe handle separating from the inflation device when handle is withdrawn.
Masimo SpO2 Saturation Values can become frozen after an extended length of use without a power down.
The patient may be exposed to potential aluminum ion release during warming therapy under certain use conditions.
Misaligned placement of an axis mark can cause the patient to experience blurred vision
Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized
The seating system unexpectedly detached, which resulted in the seating system falling to the ground, causing injury.
Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized
There is a potential that the coin cell battery used to monitor X-Ray tube temperature may deplete early causing the system to become inoperable.
There is the potential for contaminated water to enter parts of the Heater-Cooler Unit circuits. There is a potential risk of bacterial contamination including Mycobacteria species.
During stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of the graft cover.
Misaligned placement of an axis mark can cause the patient to experience blurred vision
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.
