Erbe Medical, LLC

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2062-2026Class IIERBEFLO CleverCap CO2: Hybrid CO2 Tubing/Cap Set for Olympus Scopes & CO2 Sources, REF: 20325-239; HMarch 31, 2026
Z-2063-2026Class IIERBEFLO CleverCap: Hybrid Tubing/Cap Set for Olympus Scopes, 20325-201; ERBEFLO CleverCap Hybrid TubMarch 31, 2026
Z-2064-2026Class IIERBEFLO 2, Endoscopy Pump Tubing/Cap Set, REF: 20325-222March 31, 2026