Recall Z-0310-2027 ยท PEA Endoscope, Accessories, Image Post-Processing For Color Enhancement
Pentax of America Inc
PENTAX Medical Water bottle assembly. Model Number. OS-H5.
| Date | Oct 28, 2026 (initiated Sep 9, 2026) |
| Status | Open, Classified |
| 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. |
| Root cause | Unknown/Undetermined by firm |
| Action | An Urgent Field Safety Notice dated 09/02/2026 was mailed to consignees. The notice informs consignees of two updates to the IFU of PENTAX Medical products, specifically the ultrasound endoscope devices and water bottle assembly. Consignees are to inform their staff of this notice and include the warning and updates to their IFUs. Additionally, consignees are instructed to change water for each procedure and fill the bottle approximately 2/3 full, or to the 200 marking on the bottle scale, with sterile water. If the water/balloon feeding function does not work consignees are to fill the water |
| Quantity | 2,972 units |
| Distribution | Worldwide - US Nationwide and International distribution - Pending. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K191282 | PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family Pentax of America, Inc., Nov 8, 2019 |