Complete FDA and NHTSA recall records dated in June 2021.
These records include useful source details for the selected month.
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.
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
Elevated rates of false negative results may occur when using blood culture panels due to issues in the manufacturing process. Pouches contained OPP from FilmArray Blood Culture…
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 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
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.
If a certain sequence of events occur, the pdf test report that belongs to one patient will appear in a different patient's record when viewed in an Electronic Medical Record (EMR) or a…
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.
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…
There is a potential for flaking metal and/or brown spots on the hemostats sold as individual units or packaged in the kits
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.
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.
No 510k for the product to be used in a natural or surgical opening to the body
There is a potential for flaking metal and/or brown spots on the hemostats sold as individual units or packaged in the kits
No 510k for the product to be used in a natural or surgical opening to the body
There is a potential for flaking metal and/or brown spots on the hemostats sold as individual units or packaged in the kits
Product contamination-a trace amount of dried bodily fluids may expose patients, health care providers to contaminates
Certain low-voltage DC power supplies (DCPS) used in these products may be subject to an increased probability of failure. Failure of a DCPS may result in the sudden loss of imaging…
No 510k for the product to be used in a natural or surgical opening to the body
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.
