Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 781–792 of 4,586 recalls
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Products were incorrectly labeled with a 5-year shelf life. The approved and validated shelf life is four years.
Potential for product to contain foreign matter, confirmed to be inspect fragments.
Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test Systems.…
Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test Systems.…
Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test Systems.…
Unapproved design changes to the products outside of the 510(k) clearance.
Unapproved design changes to the products outside of the 510(k) clearance.