Pentax Of America Inc: Endoscopic Ultrasound System, Gastroenterology-urology
Recall Summary Pentax of America is recalling the PENTAX Medical Ultrasound Endoscope Model EG-3270UK due to missing warnings in the instruction manual. The warnings address the need for deaerated sterile water in the water bottle assembly before and during procedures. This device is used in gastroenterology and urology procedures and has been distributed nationwide and internationally.
- Recalling firm
- Pentax of America Inc
- Product
- PENTAX Medical Ultrasound Endoscope. Model Number. EG-3270UK.
- 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/5bce26eb-b368-4aa7-85a0-7bd9b3b0cc5f