EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video… — Class II medical device recall Z-2116-2014
Terminated recall by Pentax Medical Company, reported 2014-07-30, distributed nationwide. Aspiration needles used in combination with Ultrasound Gastroscopes can derail from the accessory elevator at
| Recall number | Z-2116-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pentax Medical Company, Montvale, NJ, United States |
| Recall initiated | 2014-06-12 |
| Classified | 2014-07-24 |
| Reported by FDA | 2014-07-30 |
| Terminated | 2015-11-17 |
| Distributed | Nationwide (US) |
| Quantity | 531 units |
| Model numbers | A01013, A01014, A01017, A01019, A01020, A01022, A01025, A01026, A01028, A01029, A01030, A01031, A01033, A01036, A01040, A01046, A01049, A01053, A01054, A01055, A01056, A01057, A01068, A01070, A01074 and 471 more |
Product
EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG-36UX Ultrasound Fiber Gastroscope Used to provide optical and sonographic visualization of and therapeutic access to the Upper Gastrointestinal Tract.
Reason for recall
Aspiration needles used in combination with Ultrasound Gastroscopes can derail from the accessory elevator at the distal end of the endoscope. This may result in patient injury if the Instruction for Use is not followed carefully by the user.
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-2116-2014. 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.