Recall Z-0310-2027— Pentax of America Inc

Name: FDA recall Z-0310-2027
Creator: U.S. Food and Drug Administration
Published: 2026-09-09

Class II · Ongoing

Class II FDA medical device recall by Pentax of America Inc, initiated 2026-09-09. It names one FDA 510(k) clearance: K191282. 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..

Recalling firm: Pentax of America Inc
Classification: Class II
Status: Ongoing
Initiated: 2026-09-09
Firm location: Montvale, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K191282 — PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI FamilyPentax of America, Inc.·cleared 2019-11-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

PENTAX Medical Water bottle assembly. Model Number. OS-H5.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.