Pentax Of America Inc: Endoscope, Accessories, Image Post-processing For Color Enhancement
Recall Summary Pentax of America is recalling the PENTAX Medical Water bottle assembly (Model OS-H5) used with ultrasound endoscopes. The company is adding warnings to the instruction manual to clarify that the water bottle must contain deaerated sterile water before and during procedures. This recall affects medical facilities nationwide and internationally that use this equipment.
- Recalling firm
- Pentax of America Inc
- Product
- PENTAX Medical Water bottle assembly. Model Number. OS-H5.
- 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/9c32898b-dffd-4634-ad0f-9ca03074701a