Device recall

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

FDA recall source

Recall number

Z-0310-2027

Event id

99782

Status

Ongoing

FDA classification

Class II

Recalling firm

Pentax of America Inc

Report date

Nov 4, 2026

Posted

Oct 28, 2026

Initiated

Sep 9, 2026

Center classification date

Oct 28, 2026

Product code

PEA

Device type

Endoscope, Accessories, Image Post-Processing For Color Enhancement

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

Quantity

2,972 units

Code info

Model No. OS-H5; UDI-DI: 04961333219940, 04961333247486, 04961333251032, 04961333251049; All Serial Numbers.

Distribution

Worldwide - US Nationwide and International distribution - Pending.

Voluntary or mandated

Voluntary: Firm initiated

Related 510(k)s

K191282

Location

Montvale, NJ, United States