Home › Richard Wolf GmbH › HIGHFLOW

HIGHFLOW

Richard Wolf GmbH · Model 2235611 · UDI-DI 04055207056592

HIF

510(k) clearances

7,497

Adverse events (34 deaths)

Recalls

140

Facilities

Description

INSUFFLATOR 45 EVAC FR 45L/MIN US version, compatible with core nova, touch screen, color display, with smoke evacuation, U: 100-240VAC, 50/60Hz, Dim. (wxhxd): 300x160x455mm

Recalls

Date	Firm	Reason
2026-06-16	Olympus Corporation of the Americas	Potential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases.
2026-05-14	ConMed Corporation	Potential for overpressure alerts.
2026-05-14	ConMed Corporation	Potential for overpressure alerts.
2026-05-14	ConMed Corporation	Potential for overpressure alerts.
2026-05-14	ConMed Corporation	Potential for overpressure alerts.
2026-05-14	ConMed Corporation	Potential for overpressure alerts.
2026-05-14	ConMed Corporation	Potential for overpressure alerts.
2026-05-14	ConMed Corporation	Potential for overpressure alerts.
2026-05-14	ConMed Corporation	Potential for overpressure alerts.
2026-05-14	ConMed Corporation	Potential for overpressure alerts.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.