FDA Device Intelligence
HomeSTERIS CORPORATION › HexaLux

HexaLux

STERIS CORPORATION · Model HexaLux Ceiling Mount · UDI-DI 00724995244286

KZF
10
510(k) clearances
401
Adverse events
5
Recalls
92
Facilities

Description

The HexaLux Ceiling-Mount Light is a powerful, next-generation LED exam light designed to be used in a multitude of rooms including the exam room, birthing suite, or intensive care unit.

Recalls

DateFirmReason
2025-10-13MRIMed Inc.Due to battery component overheating while charging resulting in melting of internal components and causing smoke.
2017-04-21Stryker CommunicationsThe exam light may have a tolerance issue with the adapter assembly, which could potentially not allow the snap ring to be seated correctly. If this is the case, there could be in
2016-11-18Ohmeda MedicalCertain power cords could overheat. The affected power cords were manufactured by Electric-Cord and are referred to as Taller Bridge power cords. The overheating of the power cord
2013-07-25Stryker CommunicationsPotential incomplete final weld on the drop tube flange.
2004-02-19Burton Medical Products CorpPivot joint on these ceiling mount lights may fail and lights may fall onto patients.

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 keyRead 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.