PENTAX Medical Ultrasound Endoscope. Model Numbers. EG-3870UTK recall (Pentax of America Inc)
Medical deviceClass IIOngoing
Summary: Pentax of America Inc is recalling PENTAX Medical Ultrasound Endoscope. Model Numbers. EG-3870UTK, EG-3670URK.. Reason: 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.
What is being recalled
PENTAX Medical Ultrasound Endoscope. Model Numbers. EG-3870UTK, EG-3670URK.
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Worldwide - US Nationwide and International distribution - Pending.
How to tell if yours is affected
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.
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-0308-2027 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | September 9, 2026 |
| Reported | November 4, 2026 |
| Company | Pentax of America Inc |
| Company location | Montvale, NJ, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 737 units |
More recalls from Pentax of America Inc · all medical device recalls · recalls from September 2026