Z-0307-2027

PENTAX Medical Ultrasound Endoscope. Model Numbers. EG38-J10UT, EG34-J10U

Name: Z-0307-2027 PENTAX Medical Ultrasound Endoscope. Model Numbers. EG38-J10UT, EG34-J10U
Creator: Pentax of America Inc
Published: 2026-09-09
License: https://open.fda.gov/license/

Pentax of America Inc / initiated 2026-09-09 / Open, Classified

FDA source

Recall record

Recall number: Z-0307-2027
Status: Open, Classified
Initiated: 2026-09-09
Posted: 2026-10-28
Recalling firm: Pentax of America Inc
Product: PENTAX Medical Ultrasound Endoscope. Model Numbers. EG38-J10UT, EG34-J10U.
Product code: ODG Endoscopic Ultrasound System, Gastroenterology-Urology
Reason for recall: 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.
FDA root cause: Unknown/Undetermined by firm
Action: An Urgent Field Safety Notice dated 09/02/2026 was mailed to consignees. The notice informs consignees of two updates to the IFU of PENTAX Medical products, specifically the ultrasound endoscope devices and water bottle assembly. Consignees are to inform their staff of this notice and include the warning and updates to their IFUs. Additionally, consignees are instructed to change water for each procedure and fill the bottle approximately 2/3 full, or to the 200 marking on the bottle scale, with sterile water. If the water/balloon feeding function does not work consignees are to fill the water bottle with deaerated sterile water. PENTAX Medical can be contacted by phone at 1-800-431-5880 Monday through Friday from 8:30 AM EST to 5:00 PM EST, or by email at [email protected].
Quantity in commerce: 182 units
Distribution: Worldwide - US Nationwide and International distribution - Pending.
Product codes and lots: 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.

Product code ODG

K200090Class IIPENTAX Medical EG-J10U Endoscopic Ultrasound System - EG34-J10U Ultrasound Upper GI Video Scope (Convex Array Type), EG36-J10UR Ultrasound Upper GI Video Scope (Radial Array Type), EG38-J10UT Ultrasound Upper GI Video Scope (Convex Array Type)Pentax of America, Inc. / cleared 2020-07-23

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About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-21, the FDA export date for this dataset. Page last changed 2026-10-30. View this recall on fda.gov (opens on fda.gov)