Moderate riskFDA DeviceClass II
Pentax ultrasound endoscopes recalled over water bottle instructions
Pentax of America added new warnings to the instructions for use for certain ultrasound endoscopes and their water bottle assemblies. The warnings say users must confirm the assembly holds deaerated sterile water before and during each procedure. The recall covers 737 units of models EG-3870UTK and EG-3670URK, all serial numbers. No injuries have been reported.
From the FDA notice · Read the official notice ↗
What to do
- Review the updated instructions for use before using these endoscopes.
- Confirm the water bottle assembly contains deaerated sterile water before and during procedures.
- Contact Pentax of America with questions about your device.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- PENTAX Medical Ultrasound Endoscope. Model Numbers. EG-3870UTK, EG-3670URK.
- Sold in
- Nationwide
- Made for
- Adults (18 years to 100 years)
This recall covers 5 products — see all of them.
Details
- Units affected
- 737 units
- Illnesses reported
- None reported
- Manufactured in
- 3 Paragon Dr, Montvale, New Jersey, United States
- Classification
- Class II
- Recall number
- Z-0308-2027
In the FDA's words
- Description
- PENTAX Medical Ultrasound Endoscope. Model Numbers. EG-3870UTK, EG-3670URK. 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. EG-3870UTK; UDI-DI: 04961333237098, 04961333239344, 04961333226603, 04961333228409, 04961333254217, 04961333237104, 04961333225828, 04961333228423; All Serial Numbers. 2. Model No. EG-3670URK; UDI-DI: 04961333237074, 04961333237081, 04961333226597, 04961333228362, 04961333254200, 04961333228386; All Serial Numbers. Distribution: Worldwide - US Nationwide and International distribution - Pending. Affected quantity: 737 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. (this page)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