Moderate riskFDA DeviceClass II
Pentax EG36-J10UR endoscope recalled over water deaeration warnings
Pentax of America added warnings to the instructions for use for certain PENTAX Medical ultrasound endoscopes and their water bottle assemblies. The warnings ask users to make sure deaerated sterile water is in the assembly before and during each procedure. The recall covers 84 units of model EG36-J10UR, 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 the affected endoscope.
- Confirm deaerated sterile water is in the water bottle assembly before and during each procedure.
- Contact Pentax of America for details on affected units, since no remedy has been specified.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- PENTAX Medical Ultrasound Endoscope. Model Number. EG36-J10UR.
- Sold in
- Nationwide
- Made for
- Adults (18 years to 100 years)
This recall covers 5 products — see all of them.
Details
- Units affected
- 84 units
- Illnesses reported
- None reported
- Manufactured in
- 3 Paragon Dr, Montvale, New Jersey, United States
- Classification
- Class II
- Recall number
- Z-0306-2027
In the FDA's words
- Description
- PENTAX Medical Ultrasound Endoscope. Model Number. EG36-J10UR. 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. EG36-J10UR; UDI-DI: 04961333239573, 04961333239580, 04961333239597, 04961333239603, 04961333239627, 04961333248919, 04961333248926, 04961333248933, 04961333248957, 04961333252756; All Serial Numbers. Distribution: Worldwide - US Nationwide and International distribution - Pending. Affected quantity: 84 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. (this page)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.Z-0310-2027 · 2,972 units