Pentax Of America Inc: Endoscopic Ultrasound System, Gastroenterology-urology
Recall Summary Pentax Medical is recalling two ultrasound endoscope models (EG-3870UTK and EG-3670URK) used in gastroenterology and urology procedures. The company is adding warnings to the instruction manual and water bottle assembly to require that sterile water used during procedures be free of air bubbles before and during use. The recall affects devices distributed nationwide and internationally.
- Recalling firm
- Pentax of America Inc
- Product
- PENTAX Medical Ultrasound Endoscope. Model Numbers. EG-3870UTK, EG-3670URK.
- 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/b8d2391b-b9ca-4c43-8ed3-21dd1dc71329