Rigid Laryngostroboscopes The Rigid Laryngostroboscopes — Class II medical device recall Z-1075-2017
Terminated recall by Pentax of America Inc, reported 2017-02-01, distributed nationwide. Pentax is initiating a Field Correction to revise the Instructions for Use of the Rigid Laryngostroboscopes Mo
| Recall number | Z-1075-2017 |
|---|---|
| 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 | 2016-12-12 |
| Classified | 2017-01-23 |
| Reported by FDA | 2017-02-01 |
| Terminated | 2019-03-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BE, BG, BR, CA, CL, DE, DK, EC, EG, ES, FI, FR, GB, HK, HR, IE, IL, IN, IT, JP, KR, KW, LB, LT, MX, MY, NL, NZ, OM, PH, PT, SA, SE, SG, TH, TR, TT, TW, ZA |
| Model numbers | 9106, 9108 |
Product
Rigid Laryngostroboscopes The Rigid Laryngostroboscopes, Models 9106 and 9108 are intended to observe glottic action with the use of a stroboscopic light source. The instrument is inserted per-orally when indications consistent with the need for observation are observed.
Reason for recall
Pentax is initiating a Field Correction to revise the Instructions for Use of the Rigid Laryngostroboscopes Model 9106 and 9108.
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-1075-2017. 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.