Recall Database
Olympus Recalls
A hospital operating room with medical equipment (representative file photo). Specific recalled device: see recall details below. Photo: FDA / Public Domain.
- Recalls in database
- 16
- Agency
- FDA
- Years covered
- 2026
- Primary hazards
- Medical Device Defects (16)
Olympus Corporation of the Americas has 16 records, all FDA medical-device recalls, and every one classifies as a medical-device defect. All 16 were published in 2026, reflecting the current FDA ingestion window.
This is an FDA-only, single-hazard hub. Use it to look up an affected device — Olympus's recalls here center on its endoscopy and surgical lines. Each row links to the FDA enforcement record with the recall classification and the firm's corrective action.
How this hub is built. This page collects the 16 recall records tied to Olympus in the current 411 Press recall dataset. Records are grouped by a normalized version of the recalling firm's name (normalizer version 2026-07-28.C3.2). Parent, subsidiary, and "doing business as" relationships are not merged unless the agency data states them, so a corporate family can appear under more than one name. Regulator for these records: FDA. They were published 2026. A recall count reflects how much recall activity fell inside the ingestion window — roughly February 2023 through May 2026, refreshed late May 2026 — not a ranking of relative safety. Larger manufacturers and higher-volume product lines file more notices. This is the current dataset, not an all-time total, and it grows as new notices are ingested. Every row links to the original agency notice.
2026 (16)
- Class II
OER-ELITE Endoscope Reprocessor Connecting Tubes.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
- Class II
OER-ELITE Endoscope Reprocessor Connecting Tubes.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
- Class II
OER-ELITE Endoscope Reprocessor Connecting Tubes.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
- Class II
OER-ELITE Endoscope Reprocessor Connecting Tubes.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
- Class II
OER-ELITE Endoscope Reprocessor Connecting Tubes.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
- Class II
OER-ELITE Endoscope Reprocessor Connecting Tubes.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
- Class II
OER-ELITE Endoscope Reprocessor Connecting Tubes.
XXX
- Class II
OER-ELITE Endoscope Reprocessor Connecting Tubes.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
- Class II
OER-ELITE Endoscope Reprocessor Connecting Tubes.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
- Class II
OER-ELITE Endoscope Reprocessor Connecting Tubes.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
- Class II
OER-ELITE Endoscope Reprocessor Connecting Tubes.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
- Class II
OER-ELITE Endoscope Reprocessor Connecting Tubes.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
- Class II
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm.
Potential for detachment of a distal tip component of the device during use.
- Class II
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm.
Potential for detachment of a distal tip component of the device during use.
- Class II
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 25cm.
Potential for detachment of a distal tip component of the device during use.
- Class II
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm.
Potential for detachment of a distal tip component of the device during use.