Device contains indications for use and device compatibility claims that have not be reviewed and approved for safety and effectiveness by the FDA. Instructions for use are not consistent with product training.
Class IIReported terminated
Distribution: Worldwide - US Nationwide distribution in the states of TX, MO, FL, MI and the countries of Albania, Azerbaijan, Bangladesh, Brazil, Cambodia, Colombia, Hong Kong, India, Indone...
Device contains indications for use and device compatibility claims that have not be reviewed and approved for safety and effectiveness by the FDA. Instructions for use are not consistent with product training.
These examples come from this result page and are not a ranking of every recall reason.
Checking Insightra Medical Inc
Is there a recall on insightra medical inc right now?
This archive contains 1 records, including 0 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.
How do I check my package or product?
Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.
Does a matching name mean every item is included?
A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.
What if the search finds no matching record?
This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.
Where can I find older records?
Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.