Pentax Video Bronchoscope Designed to be used with a Pentax Video… — Class II medical device recall Z-2875-2016
Terminated recall by Pentax of America Inc, reported 2016-09-28, distributed nationwide. Pentax America Inc. is recalling various bronchoscopes which contain an incorrect Operation and Reprocessing I
| Recall number | Z-2875-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pentax of America Inc, Montvale, NJ, United States |
| Recall initiated | 2016-05-31 |
| Classified | 2016-09-22 |
| Reported by FDA | 2016-09-28 |
| Terminated | 2017-12-21 |
| Distributed | Nationwide (US) |
| Quantity | 1,719 units |
Product
Pentax Video Bronchoscope Designed to be used with a Pentax Video Processor (including light source), documentation equipment, video monitor, endo-therapy accessories (such as biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.
Reason for recall
Pentax America Inc. is recalling various bronchoscopes which contain an incorrect Operation and Reprocessing IFUS.
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-2875-2016. 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.