The Biomed Guys

FDA Regulatory Profile

The Biomed Guys appears in FDA public data with 1 recall — including 1 Class I (most serious) —, 0 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-1651-2021, Class I) was initiated on March 25, 2021.

Summary

Total Recalls
1 (1 Class I)
510(k) Clearances
0
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1651-2021Class IAlaris Infusion Pump Module, Model 8100, serviced/repaired by The Biomed Guys, with the impacted bezMarch 25, 2021