CLASS II ONGOING Device recall · Reported 11 Mar 2026 · FDA Enforcement Report
Olympus Single Use Biopsy Valve recalled by Olympus Corporation of the
Olympus Corporation of the Americas is recalling Olympus Single Use Biopsy Valve, distributed nationwide in the US. The recall was initiated on 29 Jan 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-1489-2026
- FDA event ID
- 98240
- Recalling firm
- Olympus Corporation of the Americas, Center Valley, PA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 29 Jan 2026
- FDA classified
- 3 Mar 2026
- Reported
- 11 Mar 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Surgical Instruments
Timeline
| 29 Jan 2026 | Recall initiated by company | |
| 3 Mar 2026 | Classified by FDA | +33 days |
| 11 Mar 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
Potential for rubber fragment detachment during use.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per box. The MAJ-1218 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent leakage of body fluids.
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
Potential for rubber fragment detachment during use.
Which lots are affected?
Model/Catalog Number: MAJ-1218. UDI-DI: 14953170154291. All Lot Numbers. 20 units per box.
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.
Other products in this recall event
1 other product · FDA event 98240This product is part of a recall event; the main page for the event is Olympus Single use Biopsy Valve recalled by Olympus Corporation of the.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Olympus Single use Biopsy Valve recalled by Olympus Corporation of the | Olympus Corporation of the Americas | Foreign Material | Nationwide |
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