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Richard Wolf GmbH · Model 4170502 · UDI-DI 04055207054116

HIF

510(k) clearances

7,600

Adverse events (34 deaths)

Recalls

141

Facilities

Description

INSUFFLATION TUBE SET L 3M high-flow with heating coil and integrated hygiene filter, PVC, PACK=10 PCS, for insufflators 2235021, 2235031, 2235621 and 2235631, sterile, for single use

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.

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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.