Olympus Corporation Of The Americas recalls Olympus M3 Gold Autoclavable Lateral Telescope 70. Model Number: M3-70A.
Reason for recall
There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- Olympus M3 Gold Autoclavable Lateral Telescope 70. Model Number:M3-70AUDI-DI 00821925005686.Model Number
What the firm is doing
Olympus notified the single Japanese distributor on about 08/24/2026 via emailed "URGENT: FIELD SAFETY NOTICE." Consignees and end users are being instructed to store a copy of the provided correct sterilization parameters with current package insert, use only the corrected sterilization parameters, complete and return the provided reply form, and if units have been further distributed, notify those customers.
DistributionShow detailsHide
International distribution to the country of Japan.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-3300-2026
- FDA 510(k) clearance · K890328The device's official FDA premarket clearance record
- FDA device classification · HIHOfficial FDA classification for this device type
- CFR regulation · 21 CFR 884.1690The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Olympus Corporation of the AmericasSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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