Pentax of America Inc recalls PENTAX Medical Ultrasound Endoscope.
- Recalling company
- Pentax of America Inc
- Product
- PENTAX Medical Ultrasound Endoscope. Model Numbers. EG38-J10UT, EG34-J10U.
- Reason
- Warnings added to the IFU for ultrasound endoscopes and water bottle assembly to ensure there is deaerated sterile water in the assembly prior to and during the procedure.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Sep 9, 2026
- Reported
- Nov 4, 2026
- Distribution
- Worldwide - US Nationwide and International distribution - Pending.
- Status
- Ongoing
- Quantity
- 182 units
- Lot / codes
- 1. Model No. EG38-J10UT; UDI-DI: 04961333239474, 04961333239481, 04961333239498, 04961333239504, 04961333239528, 04961333252770; All Serial Numbers. 2. Model No. EG34-J10U; UDI-DI: 04961333239672, 04961333239689, 04961333239696, 04961333239702, 04961333239726, 04961333248834, 04961333248841, 04961333248858, 04961333248872, 04961333248896, 04961333252732; All Serial Numbers.
- Company location
- Montvale, NJ
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-0307-2027
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0307-2027 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.