Complete FDA and NHTSA recall records dated in 2021, organized for browsing by month, category and recalling company.
Select a month to review the recall records reported during that period.
Records are ordered by the best available source date.
There is a potential for flaking metal and/or brown spots on the hemostats sold as individual units or packaged in the kits
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
The device components experienced a manufacturing process error that resulted in surface damage from product handling.
Due to a software issue, patients with a urine drug screen (UDS) received access to a contingency management wheel spin for potential rewards regardless of the UDS results. Positive UDS…
No 510k for the product to be used in a natural or surgical opening to the body
No 510k for the product to be used in a natural or surgical opening to the body
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Due to issue with product sterility. Sterilization service provider had falsified records.
No 510k for the product to be used in a natural or surgical opening to the body
No 510k for the product to be used in a natural or surgical opening to the body
Reports received of NO measured below desired dose during transition between primary console and backup console since Software Version 2.2.3 was uploaded to consoles in the field.
Due to a component failure, ventilators may unexpectedly shut down or have a loss of blower function while in patient use. The shutdown potentially prevents the ventilator from providing…
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
No 510k for the product to be used in a natural or surgical opening to the body
SARS-CoV-2 lgG II numerical results may potentially be multiplied by a factor of 1000 on systems running with assay protocol file (APF) and access assay file (AAF) versions resulting in…
No 510k for the product to be used in a natural or surgical opening to the body
Product may be contaminated with Listeria monocytogenes.
Product may be contaminated with Listeria monocytogenes.
Product may be contaminated with Listeria monocytogenes.
Product may be contaminated with Listeria monocytogenes.
Product may be contaminated with Listeria monocytogenes.
Product may be contaminated with Listeria monocytogenes.
Products are deficient in multiple nutrients required for infant formula, and the firms contract manufacturer does not test for Cronobacter, a pathogen that can be particularly dangerous to…
Product may be contaminated with Listeria monocytogenes.
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.
