Complete FDA and NHTSA recall records dated in June 2021.
These records include useful source details for the selected month.
No 510k for the product to be used in a natural or surgical opening to the body
LED pads with cord connectors that have v-shaped notches may not have been assembled properly. This issue could lead to a power interruption, causing the controller and power supply to shut…
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 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…
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.
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
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.
