CLASS II ONGOING Device recall · Reported 15 Jul 2026 · FDA Enforcement Report
Olympus Single Use Distal Cover recalled by Olympus Corporation of the
Olympus Corporation of the Americas is recalling Olympus Single Use Distal Cover, distributed nationwide in the US. The recall was initiated on 5 Jun 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2676-2026
- FDA event ID
- 99106
- Recalling firm
- Olympus Corporation of the Americas, Center Valley, PA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 5 Jun 2026
- FDA classified
- 7 Jul 2026
- Reported
- 15 Jul 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 5 Jun 2026 | Recall initiated by company | |
| 7 Jul 2026 | Classified by FDA | +32 days |
| 15 Jul 2026 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers.
Product as listed by the FDA
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
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers.
Which lots are affected?
UDI/DI: 04953170441271, Lot Numbers: H2530 or later
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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