Olympus Corporation of the Americas
Olympus Corporation of the Americas holds FDA 510(k) medical device clearance, cleared in 2014, with 415 FDA device recalls on record.
Top product codes for Olympus Corporation of the Americas
FDA recalls by Olympus Corporation of the Americas
10 most recent of 415- Z-3035-2026 — POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Electrosurgical, cutting & coagulation & accessories
- Z-2761-2026 — Olympus 4K UHD LCD Monitor. Model Number: OEV321UH. An electrically powered visual display unit designed for displaying graphical information in color.
- Z-2776-2026 — Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4
- Z-2676-2026 — Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olympus duodenovideoscopes to cover the distal end of the insertion tube and around the forceps elevator; duodenoscope and accessories, flexible/rigid
- Z-2720-2026 — Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb. Model Number: 194.
- Z-2718-2026 — Olympus Toomey Evacuator 30cc with Adaptor. Model Number: 188.
- Z-2721-2026 — Olympus Glass Body for 194 Ellik Evacuator. Model Number: 190A.
- Z-2719-2026 — Olympus Toomey Evacuator 50cc with Adaptor. Model Number: 188A.
- Z-1903-2026 — OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2115.
- Z-1901-2026 — OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2113.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Olympus Corporation of the Americas
Data sourced from openFDA. This site is unofficial and independent of the FDA.