Monitor U.S. medical device recall enforcement reports from the FDA. Review product descriptions, recall reasons, classifications, dates, recalling firms and distribution information where the FDA provides them.
24,725 detailed records are currently available in this category.
During stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of the graft cover.
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.
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.
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
Misaligned placement of an axis mark can cause the patient to experience blurred vision
The patient may be exposed to potential aluminum ion release during warming therapy under certain use conditions.
Masimo SpO2 Saturation Values can become frozen after an extended length of use without a power down.
Due to a design issue, inflation syringe handle separating from the inflation device when handle is withdrawn.
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
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
Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized
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.
The seating system unexpectedly detached, which resulted in the seating system falling to the ground, causing injury.
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…
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…
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
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.
Medical device recall records can change as the FDA receives additional information. Check the official record identifier and current FDA information before making health or product-use decisions.
Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.
This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.
