Pentax Ultrasound Endoscope Recall for Missing Deaerated Water Warnings
Pentax of America Inc is recalling 65 ultrasound endoscopes to add warnings ensuring deaerated sterile water is used in the assembly during procedures.
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 a Class II action to add warnings to the Instructions for Use regarding the use of deaerated sterile water. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Pentax of America Inc is recalling 65 units of the PENTAX Medical Ultrasound Endoscope, Model Number EG-3270UK. The recall involves all serial numbers for this model, identified by specific UDI-DI codes. The distribution is listed as worldwide, including US Nationwide and International, though the specific scope is pending.
The recall is being conducted to add 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 source text does not report any illnesses, injuries, or deaths associated with this product.
Healthcare facilities and users should stop using the affected devices and follow the instructions provided by the recalling firm regarding the updated documentation. The recall is classified as Class II by the FDA.
The recalled product
- Product
- PENTAX Medical Ultrasound Endoscope. Model Number. EG-3270UK.
- Manufacturer
- Pentax of America Inc
- Category
- Medical Device — Endoscope
- Affected units
- 65
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 (7)
- Model No. EG-3270UK
- UDI-DI: 04961333237050
- 04961333237067
- 04961333226580
- 04961333254187
- 04961333233793
- All Serial Numbers.
Distribution
Distributed nationwide across the United States.
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