AZNO news
FDA Posts Instruction Correction for PENTAX Ultrasound Endoscopes
FDA records posted October 28 describe an earlier PENTAX ultrasound-endoscope instruction correction. Check the listed models, dates and current manufacturer notice.
Source announcement:
FDA recall records; observed October29,2026
A new FDA posting of a September instruction correction
FDA recall records posted on October 28 describe an instruction correction for five PENTAX Medical ultrasound-endoscope models and the OS-H5 water bottle assembly. The publication date is new; the records identify September 9, 2026 as the firm’s initiation date and cite an urgent field safety notice dated September 2.
The endoscope models listed are EG38-J10UT, EG34-J10U, EG-3870UTK, EG-3670URK and EG-3270UK. Four database entries link these products and the water bottle assembly under recall event 99782. Each entry identifies all serial numbers for its listed model or models. The records classify the action as Class II and show it as open at the time AZNO reviewed them.
According to the FDA entries, the correction adds warnings to the instructions for use concerning deaerated sterile water in the water bottle assembly. The listed action asks recipients to inform staff and incorporate the warnings and updates into their IFUs. The current PENTAX notice and applicable product instructions remain the sources for the complete handling procedure; this news report is a summary of the public records.
AZNO editorial interpretation
Check the documentation for the exact endoscope and accessory
For equipment owners and teams evaluating secondhand endoscopic-ultrasound equipment, the practical documentation question is whether the exact endoscope and accessory are supported by the current instructions. Keep the full model, serial number, accessory identity and version of the applicable notice together when checking the record. A model-family description or an older manual alone leaves that question unresolved.
The FDA entries describe an instruction update. They do not by themselves establish a failed transducer, the need for a replacement probe, or the outcome for a particular unit. AZNO has not inspected affected equipment or verified that an individual facility has completed the correction. Confirm model applicability and the current manufacturer instructions through the responsible equipment and clinical teams.