Moderate riskFDA DeviceClass II
Pentax ultrasound endoscopes recalled over sterile water warnings
Pentax of America is updating the instructions for use on certain PENTAX Medical ultrasound endoscopes (models EG38-J10UT and EG34-J10U) and their water bottle assemblies. The new warnings instruct users to make sure deaerated sterile water is in the assembly before and during procedures. The recall covers 182 units, all serial numbers, and no injuries have been reported.
From the FDA notice · Read the official notice ↗
What to do
- Review the updated instructions for use before using affected endoscopes.
- Confirm deaerated sterile water is in the water bottle assembly before and during each procedure.
- Contact Pentax of America for questions about affected units or next steps.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- PENTAX Medical Ultrasound Endoscope. Model Numbers. EG38-J10UT, EG34-J10U.
- Sold in
- Nationwide
- Made for
- All ages (under 100 years)
This recall covers 5 products — see all of them.
Details
- Units affected
- 182 units
- Illnesses reported
- None reported
- Manufactured in
- 3 Paragon Dr, Montvale, New Jersey, United States
- Classification
- Class II
- Recall number
- Z-0307-2027
In the FDA's words
- Description
- PENTAX Medical Ultrasound Endoscope. Model Numbers. EG38-J10UT, EG34-J10U. 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. 1. Model No. EG38-J10UT; UDI-DI: 04961333239474, 04961333239481, 04961333239498, 04961333239504, 04961333239528, 04961333252770; All Serial Numbers. 2. Model No. EG34-J10U; UDI-DI: 04961333239672, 04961333239689, 04961333239696, 04961333239702, 04961333239726, 04961333248834, 04961333248841, 04961333248858, 04961333248872, 04961333248896, 04961333252732; All Serial Numbers. Distribution: Worldwide - US Nationwide and International distribution - Pending. Affected quantity: 182 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. (this page)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.Z-0310-2027 · 2,972 units