Pentax Of America Inc: Endoscopic Ultrasound System, Gastroenterology-urology
Recall Summary Pentax of America is recalling certain ultrasound endoscopes (models EG38-J10UT and EG34-J10U) used in gastroenterology and urology procedures. The company is adding warnings to the instruction manuals and water bottle assembly instructions to emphasize the need for deaerated sterile water during procedures. This Class II recall affects devices distributed nationwide and internationally.
- Recalling firm
- 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
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-09-09
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide - US Nationwide and International distribution - Pending.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/2836bb1d-b9ce-4439-8e6f-15c8bd9d6279