Reported Nov 4, 2026 · Ongoing
PENTAX Medical Water bottle assembly. Model Number. OS-H5.
Pentax of America Inc
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Pentax of America Inc · 3 Paragon Dr · Montvale, NJ · 07645-1782
Is this the product you have?
- PENTAX Medical Water bottle assembly. Model Number. OS-H5.
- Lot codes and dates
- Model No. OS-H5
- UDI-DI
04961333219940049613332474860496133325103204961333251049All Serial Numbers
- Amount recalled
- 2,972 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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