Erbe Medical, LLC FDA Recalls

3 recalls on file across devices, 0 of them Class I and 3 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
ERBEFLO 2, Endoscopy Pump Tubing/Cap Set, REF: 20325-222Class IIMar 31, 2026Devices providing sterile water/CO2/air to endoscopes were m	Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment conne	Class IIDevices	Mar 31, 2026
ERBEFLO CleverCap CO2: Hybrid CO2 Tubing/Cap Set for Olympus Scopes & CO2 Sources, REF: 20325-239; Hybrid CO2 Tubing/CapClass IIMar 31, 2026Devices providing sterile water/CO2/air to endoscopes were m	Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment conne	Class IIDevices	Mar 31, 2026
ERBEFLO CleverCap: Hybrid Tubing/Cap Set for Olympus Scopes, 20325-201; ERBEFLO CleverCap Hybrid Tubing/Cap Set for FujiClass IIMar 31, 2026Devices providing sterile water/CO2/air to endoscopes were m	Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment conne	Class IIDevices	Mar 31, 2026