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.
27,577 detailed records are currently available in this category.
Software discrepancy of not showing all the EE constants, when the screen is filled.
A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.
Certain lots of the defibrillation electrodes model DF59N and DF59NC may have a delay in connecting or not connect at all with the defibrillator ZOLL AED PLUS. This may cause a situation in…
It was discovered during a procedure that when the operator made an exposure on the wireless x-ray detector and the image data was sent to the digital radiography system, and error message…
A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.
A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.
The device history record (DHR) was missing its test documentation for final HIPOT (high potential) electrical testing.
Complaints were received reporting the system would freeze/shut down while in Fulgurate mode.
The firm received increased customer complaints for Missing Red Line, Patient Slow Flow, Solution Slow Flow, and Inadequate Drain alerts on certain lots of the AMIA Automated Peritoneal…
Some anomalies have been identified during manufacturing controls.
Failure to comply with performance standard requirements (21 CFR 1040.10(f))when operated in the user accessible auto and music modes of operation
A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.
A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.
Fujifilm is reporting a corrective action due to an FDA inspection.
Beckman Coulter has determined that additional clarification for the Blast Suspect messages is necessary. In rare situations, the LH 750, LH 780, LH 500 and HmX Analyzers may not flag or…
Three (3) complaints were identified in which the potential for utilization of the JTS Grower Drive in the incorrect orientation in relation to the limb entry point of the device, together…
There is a potential for the hydrophilic coating on the guidewire to delaminate from the guidewire.
The software is not identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation.
Specific lots have been reported to produce falsely lower than expected results for Vitamin D
The firm manufactured and distributed Presource(R) kits which contained BD SafetyGlide" 22GA 1 inch Needles. BD subsequently recalled these needles because, " Loose polypropylene…
False blood back detection alarm and the ingress of fluids into the IABP affecting various electronic circuit boards could potentially prevent initiation or continuation of therapy.
Mix-up RGA (Return Goods Authorization) leading to 5 devices being redistributed and implanted 2 patients.
False blood back detection alarm and the ingress of fluids into the IABP affecting various electronic circuit boards could potentially prevent initiation or continuation of therapy.
False blood back detection alarm and the ingress of fluids into the IABP affecting various electronic circuit boards could potentially prevent initiation or continuation of therapy.
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.
