Has there been a GranuFlo / NaturaLyte FDA recall?

Yes. The FDA issued a Class I recall for NaturaLyte and GranuFlo on March 29, 2012. Class I recalls are the most serious type of recall. They involve situations in which there is a reasonable probability that use of the recalled products will cause serious adverse health consequences or death. The FDA also issued a general safety communication on May 25, 2012, related to inappropriate prescription and resultant alkali dosing errors in dialysate concentrates used in hemodialysis.