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econom® XL 3.5 V,

Rudolf Riester GmbH · Model 2052-202 · UDI-DI 04045396130616

EPY

510(k) clearances

Adverse events

Recalls

231

Facilities

Description

The Riester otoscope is produced for illumination and examination of the auditory canal in combination with Riester ear specula The Riester ophthalmoscope is produced for the examination of the eye and the eyeground. The nasal speculum is produced for illumination and therefore examination of the inside of the nose. The blade holder is produced for examination of the oral cavity and pharynx in combination with commercial wooden and plastic blades. The laryngeal mirrors are produced for mirroring or examination of the oral cavity and pharynx in combination with the Riester bent-arm illuminator.

Recalls

Date	Firm	Reason
2024-12-03	Sklar Instruments	Reports of various packaging issues that may result in a breach of the sterile barrier.
2024-02-23	MEDLINE INDUSTRIES, LP - Northfield	Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.

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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.