Recall

Could cause harm

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

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.

FDA enforcement record

What to do

Does your product match this recall?

Scan your barcode or label to compare your product with this notice. We’ll help you check the lot or date code when needed.

Scan Barcode

No account or app download needed. A barcode may need a lot code to confirm a match.

  1. 1Compare the product, size and lot or date code with this notice.
  2. 2If your product matches, stop using it and follow the official recall instructions.
  3. 3Read the official notice for return, refund or disposal instructions.

Recall details

Firm
Pentax of America Inc
Status
Posted
Reported
Oct 28, 2026
Started
Sep 9, 2026
Where sold
Worldwide - US Nationwide and International distribution - Pending.
Quantity
2,972 units
Notice number
Z-0310-2027

Lots, UPC, dates

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

Agency wording

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

Source: FDA enforcement. This is not medical advice. Compare your package codes before you act.