PENTAX Medical Ultrasound Endoscope. Model Number. EG36-J10UR.
Pentax of America Inc · 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 th…
Open FDA's page for this record- Cfres ID
- 222476
- Product res number
- Z-0306-2027
- Event date initiated
- 2026-09-09
- Event date posted
- 2026-10-28
- Recall status
- Open, Classified
- Res event number
- 99782
- Product code
- ODG
- Product description
- PENTAX Medical Ultrasound Endoscope. Model Number. EG36-J10UR.
- Firm FEI number
- 1000080301
- Recalling firm
- Pentax of America Inc
- Address 1
- 3 Paragon Dr
- City
- Montvale
- State
- NJ
- Postal code
- 07645-1782
- Additional info contact
- PENTAX Medical Customer Service 800-431-5880
- Root cause description
- Unknown/Undetermined by firm
- Product quantity
- 84 units
- Distribution pattern
- Worldwide - US Nationwide and International distribution - Pending.
- Code info
Model No. EG36-J10UR; UDI-DI: 04961333239573, 04961333239580, 04961333239597, 04961333239603, 04961333239627, 04961333248919, 04961333248926, 04961333248933, 04961333248957, 04961333252756; All Serial Numbers.
- Reason for recall
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.
- Action
An Urgent Field Safety Notice dated 09/02/2026 was mailed to consignees. The notice informs consignees of two updates to the IFU of PENTAX Medical products, specifically the ultrasound endoscope devices and water bottle assembly. Consignees are to inform their staff of this notice and include the warning and updates to their IFUs. Additionally, consignees are instructed to change water for each procedure and fill the bottle approximately 2/3 full, or to the 200 marking on the bottle scale, with sterile water. If the water/balloon feeding function does not work consignees are to fill the water bottle with deaerated sterile water. PENTAX Medical can be contacted by phone at 1-800-431-5880 Monday through Friday from 8:30 AM EST to 5:00 PM EST, or by email at customeradvisories@pentaxmedical.com.
- K numbers
- K200090
- Harmonized identifiers (openFDA)
- Device name
- Endoscopic Ultrasound System, Gastroenterology-Urology
- Medical specialty description
- Gastroenterology, Urology
- Regulation number
- 876.1500
- Device class
- 2
- K number
- K221952, K130247, K112198, K023401, K061068, K162447, K231813, K221238, K011886, K926514, K090196, K173184, K042140, K212852, K021278, K251859, K090197, K110030, K232518, K163058, K031789, K260428, K203166, K200090, K251542, K133312, K182004, K021276, K982734, K010591, K183433, K214089, K961048, K130206, K160845, K180731, K031347, K171207, K904573, K953876 +4 more
- Registration number
- 3003782610, 3006161756, 9610877, 3015924373, 9610595, 3005580113, 3013440400, 3007738736, 9611680, 3010273872, 9614641, 3009526575, 3001845648, 3035950510, 3008386005, 3043226252, 8010047, 3012494290, 3014579161, 1225687, 3014769442, 3042172882, 2025773, 3017968993, 3017140456, 3042225166, 3002807314, 3005099803, 1528319, 3003637092, 3002808148, 3000296634, 1000121056, 3043585886, 9681260, 3014605202, 1828132, 3004837686, 3011050570
- FEI number
- 3003782610, 3015924373, 3005580113, 3013440400, 3007738736, 3001451463, 3010273872, 3002806565, 3009526575, 3002807969, 3001845648, 3035950510, 3002807795, 3002808127, 3002964398, 3008386005, 3043226252, 3012494290, 3014579161, 1000122656, 3014769442, 3042172882, 2025773, 3017968993, 3017140456, 3042225166, 3002807314, 3005099803, 3003637092, 3003995201, 3002808148, 3000296634, 1000121056, 3043585886, 3014605202, 1828132, 3004837686, 3011050570, 3008185830