Pentax Of America Inc: Endoscopic Ultrasound System, Gastroenterology-urology
Recall Summary Pentax of America is recalling the PENTAX Medical Ultrasound Endoscope Model EG36-J10UR because updated warnings need to be added to the instructions for use regarding proper preparation of sterile water in the water bottle assembly before procedures. This is a Class II recall affecting devices distributed nationwide and internationally.
- Recalling firm
- Pentax of America Inc
- Product
- PENTAX Medical Ultrasound Endoscope. Model Number. EG36-J10UR.
- 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/e82cfaf8-8796-4cb0-88cb-6ae063cff79d