Moderate riskFDA DeviceClass II
PENTAX OS-H5 water bottle assembly recalled for labeling gap
Pentax of America is recalling the PENTAX Medical water bottle assembly, Model OS-H5, used with ultrasound endoscopes. The company added warnings to the instructions for use to make sure the assembly contains deaerated sterile water before and during procedures. No injuries have been reported.
From the FDA notice · Read the official notice ↗
What to do
- Check whether your water bottle assembly is Model OS-H5 with a UDI-DI listed in the notice.
- Follow the updated instructions to confirm deaerated sterile water is in the assembly before and during procedures.
- Contact Pentax of America for next steps, since the notice does not list a specific remedy.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- PENTAX Medical Water bottle assembly. Model Number. OS-H5.
- Sold in
- Nationwide
- Made for
- All ages (under 100 years)
This recall covers 5 products — see all of them.
Details
- Units affected
- 2,972 units
- Illnesses reported
- None reported
- Manufactured in
- 3 Paragon Dr, Montvale, New Jersey, United States
- Classification
- Class II
- Recall number
- Z-0310-2027
In the FDA's words
- Description
- 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. Model No. OS-H5; UDI-DI: 04961333219940, 04961333247486, 04961333251032, 04961333251049; All Serial Numbers. Distribution: Worldwide - US Nationwide and International distribution - Pending. Affected quantity: 2,972 units
- Hazard
- 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.
5 products in this recall
The agency lists each product separately. Check every one you might have.
- PENTAX Medical Ultrasound Endoscope. Model Number. EG36-J10UR.Z-0306-2027 · 84 units
- PENTAX Medical Ultrasound Endoscope. Model Numbers. EG38-J10UT, EG34-J10U.Z-0307-2027 · 182 units
- PENTAX Medical Ultrasound Endoscope. Model Numbers. EG-3870UTK, EG-3670URK.Z-0308-2027 · 737 units
- PENTAX Medical Ultrasound Endoscope. Model Number. EG-3270UK.Z-0309-2027 · 65 units
- PENTAX Medical Water bottle assembly. Model Number. OS-H5. (this page)Z-0310-2027 · 2,972 units