Olympus MAJ-209 Single Use Suction Valves — Class II medical device recall Z-2148-2019
Terminated recall by Olympus Corporation of the Americas, reported 2019-08-14, distributed nationwide. There is a potential for the single use suction valve to come apart and/or remain stuck inside the endoscope.
| Recall number | Z-2148-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Olympus Corporation of the Americas, Center Valley, PA, United States |
| Recall initiated | 2019-04-01 |
| Classified | 2019-08-02 |
| Reported by FDA | 2019-08-14 |
| Terminated | 2020-06-09 |
| Distributed | Nationwide (US) |
| Quantity | 310,000 |
| Lot numbers | 88H, 89H, 8XH, 8YH, 8ZH, 91H |
| Model numbers | MAJ-209 |
Product
Olympus MAJ-209 Single Use Suction Valves, Model Number MAJ-209 Product Usage: This product has been designed to be attached to the suction cylinder of compatible endoscopes for aspirating fluid from the distal end of the endoscopes through the instrument channel. Compatible endoscopes include Olympus bronchoscopes, cystoscopes, rhino-laryngoscopes and pleurascopes models.
Reason for recall
There is a potential for the single use suction valve to come apart and/or remain stuck inside the endoscope.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2148-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.