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Richard Wolf GmbH · Model 8170865 · UDI-DI 04055207014196

HIF
10
510(k) clearances
7,497
Adverse events (34 deaths)
29
Recalls
140
Facilities

Description

IRRIGATION CANNULA FOR TEM WL 215MM for 0.5 liter irrigation bottle in combination with TEM pump, reusable

Recalls

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