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THERMOFLATOR

Karl Storz GmbH & Co. KG · Model 26432020-1 · UDI-DI 04048551069264

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

Description

THERMOFLATOR® SCB

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.