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U.S. Department of Health and Human Services

Class 2 Device Recall PENTAX Medical Ultrasound Endoscope

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 Class 2 Device Recall PENTAX Medical Ultrasound Endoscopesee related information
Date Initiated by FirmSeptember 09, 2026
Date PostedOctober 28, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0307-2027
Recall Event ID 99782
510(K)NumberK200090 
Product Classification Endoscopic ultrasound system, gastroenterology-urology - Product Code ODG
ProductPENTAX Medical Ultrasound Endoscope. Model Numbers. EG38-J10UT, EG34-J10U.
Code Information 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.
FEI Number 1000080301
Recalling Firm/
Manufacturer		 Pentax of America Inc
3 Paragon Dr
Montvale NJ 07645-1782
For Additional Information ContactPENTAX Medical Customer Service
800-431-5880
Manufacturer 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 Determined
Cause 2		Unknown/Undetermined by firm
ActionAn 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 customeradvisories@pentaxmedical.com.
Quantity in Commerce182 units
DistributionWorldwide - US Nationwide and International distribution - Pending.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = ODG
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