Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 25–31 of 31 recalls
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
Potential risk of Quality Control failures and/or false resistant antibiotic results when testing isolates of Enterobacterales/Enterobacteriaceae species and/or Pseudomonas aeruginosa with the identified antibiotic formu…
Reason for the voluntary recall is some products in this lot are not passing through a 25ga cannula smoothly.
Multiple plate failures documented as a result of the Low Positive Template Control being too high and out of range using the affected lot of ColoSense Test Kit.
There is a potential for the Inline Controller to be using the spring out of specification causing a loss of positive pressure resulting in the Neo-Tee Resuscitator and/or Circuit will not reach the high and low ends of…
Red button used to engage side rails can break or become stuck making it difficult to engage the side rail.