Pentax Ultrasound Endoscope Recall for Water Bottle Assembly Warnings
Pentax of America Inc is recalling 84 units of the EG36-J10UR Ultrasound Endoscope to add warnings ensuring deaerated sterile water is used in the water bottle assembly.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is an FDA Class II involving the addition of warnings to ensure the use of deaerated sterile water in the water bottle assembly. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Pentax of America Inc is recalling 84 units of the PENTAX Medical Ultrasound Endoscope, Model Number EG36-J10UR. The recall involves the addition of warnings to the Instructions for Use (IFU) for the ultrasound endoscopes and water bottle assembly. These warnings are intended to ensure that deaerated sterile water is present in the assembly prior to and during the procedure.
The affected units were distributed worldwide, including US Nationwide and International distribution, though the specific distribution status is pending. The recall covers all serial numbers for the specified model and UDI-DI codes.
The source text does not report any illnesses, injuries, or deaths associated with this recall. Users should refer to the updated Instructions for Use to ensure proper use of deaerated sterile water in the water bottle assembly.
The recalled product
- Product
- PENTAX Medical Ultrasound Endoscope. Model Number. EG36-J10UR.
- Manufacturer
- Pentax of America Inc
- Category
- Medical Device — Endoscope
- Affected units
- 84
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (12)
- Model No. EG36-J10UR
- UDI-DI: 04961333239573
- 04961333239580
- 04961333239597
- 04961333239603
- 04961333239627
- 04961333248919
- 04961333248926
- 04961333248933
- 04961333248957
- 04961333252756
- All Serial Numbers.
Distribution
Distributed nationwide across the United States.
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