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.
24,239 detailed records are currently available in this category.
Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the…
Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the…
SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis .
Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the…
Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the…
Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
Software anomalies that may lead to the generation of erroneous results.
Traces of corrosion on the laser marking was detected on cannulated graduated drill bit, which could lead to the emission of wear / corrosion particles in the operated area, potentially…
Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological adverse events…
Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological adverse events…
Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological adverse events…
Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking or separation of the posts from the bezel. The…
Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
Major errors (Resistant result instead of Susceptible result) were observed with Pseudomonas aeruginosa strains.
Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological adverse events…
There is a potential that a package sheath contains an incorrect dilator.
System errors were noted following changes the customers implemented to the configuration of their network and server systems. Gateway Server System performance anomalies resulted in…
Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological adverse events…
Excess nylon flash on the clip.
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.
