FDA recall, , Moderate risk
Pentax Medical Ultrasound Endoscopes and Water Bottle Assembly
Warnings were added to the instructions for use for ultrasound endoscopes and water bottle assembly.
Summary by Recall Canary from the FDA notice
What happened
Pentax of America Inc, located in Montvale, New Jersey, voluntarily initiated a recall of its Pentax Medical Ultrasound Endoscope and Pentax Medical Water bottle assembly after warnings were added to the instructions for use to ensure there is deaerated sterile water in the assembly prior to and during the procedure.
The recall began on September 9, 2026, and was added to the FDA's Enforcement Report on October 28, 2026. Distribution is worldwide, including US nationwide and international distribution.
The affected products include the ultrasound endoscope models EG36-J10UR, EG38-J10UT, EG34-J10U, EG-3870UTK, EG-3670URK, and EG-3270UK, as well as the water bottle assembly model OS-H5. Customers were notified by letter.
What to do
The FDA notice gives no instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your bottle affected?
5 products
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
A UDI-DI is the device identifier printed with the barcode on the device label.
PENTAX Medical Water bottle assembly. Model Number. OS-H5.
- UDI-DI
- 04961333219940
- 04961333247486
- 04961333251032
- 04961333251049
- Lot code
- Model No. OS-H5; UDI-DI: 04961333219940
- 04961333251049; All Serial Numbers.
PENTAX Medical Ultrasound Endoscope. Model Number. EG36-J10UR.
- UDI-DI
- 04961333239573
- 04961333239580
- 04961333239597
- 04961333239603
- 04961333239627
- 04961333248919
- 04961333248926
- 04961333248933
- 04961333248957
- 04961333252756
- Lot code
- Model No. EG36-J10UR; UDI-DI: 04961333239573
- 04961333252756; All Serial Numbers.
PENTAX Medical Ultrasound Endoscope. Model Numbers. EG38-J10UT, EG34-J10U.
- UDI-DI
- 04961333239474
- 04961333239481
- 04961333239498
- 04961333239504
- 04961333239528
- 04961333252770
- 04961333239672
- 04961333239689
- 04961333239696
- 04961333239702
- 04961333239726
- 04961333248834
- 04961333248841
- 04961333248858
- 04961333248872
- 04961333248896
- 04961333252732
- Lot code
- 1. Model No. EG38-J10UT; UDI-DI: 04961333239474
- 04961333252770; All Serial Numbers. 2. Model No. EG34-J10U; UDI-DI: 04961333239672
- 04961333252732; All Serial Numbers.
PENTAX Medical Ultrasound Endoscope. Model Numbers. EG-3870UTK, EG-3670URK.
- UDI-DI
- 04961333237098
- 04961333239344
- 04961333226603
- 04961333228409
- 04961333254217
- 04961333237104
- 04961333225828
- 04961333228423
- 04961333237074
- 04961333237081
- 04961333226597
- 04961333228362
- 04961333254200
- 04961333228386
- Lot code
- 1. Model No. EG-3870UTK; UDI-DI: 04961333237098
- 04961333228423; All Serial Numbers. 2. Model No. EG-3670URK; UDI-DI: 04961333237074
- 04961333228386; All Serial Numbers.
PENTAX Medical Ultrasound Endoscope. Model Number. EG-3270UK.
- UDI-DI
- 04961333237050
- 04961333237067
- 04961333226580
- 04961333254187
- 04961333233793
- Lot code
- Model No. EG-3270UK; UDI-DI: 04961333237050
- 04961333233793; All Serial Numbers.
Recall details
- Posted by FDA
- Recall began
- Status
- Open
- Weekly archive
- Listed the week of Oct 26, 2026
- Sold in
Worldwide - US Nationwide and International distribution - Pending.
- Recalled by
- Pentax of America IncMontvale, New Jersey
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- FDA event number
- 99782
- Recall numbers
- Z-0306-2027 to Z-0310-2027
- Recall type
- Voluntary: Firm initiated
- How the company first told customers
- Letter
All recalls from Pentax of America Inc
Timeline
FDA's Enforcement Report is its public list of recalls; FDA posts a recall by adding it there.
Pentax began the recall
FDA posted the recall to its Enforcement Report and rated it Class II (moderate risk)
Added to Recall Canary
Summary updated
