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.
1,218 detailed records are currently available in this category.
Due to increased complaints for broken/frayed grip cables for reusable instruments.
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the…
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Urgent Medical Device Correction for the Volara system single-patient use circuit due to the potential that patients or caregivers may be unaware of a possible decrease in oxygen levels…
In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential…
Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system to become inoperable.…
Potential for the balloon in the device to not meet burst specifications.
Due to increased complaints for broken/frayed grip cables for reusable instruments.
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated…
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the…
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential…
In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments
Potential for attenuation degradation over time, decreasing the lifespan.
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames to display out of sequence.
Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use.
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.
