Pentax Medical Ultrasound Endoscope Recall for Warning Label Updates
Pentax of America Inc is recalling 182 ultrasound endoscopes to add warnings ensuring deaerated sterile water is used in the 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 the Instructions for Use to ensure proper use of deaerated sterile water. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Pentax of America Inc is recalling 182 units of PENTAX Medical Ultrasound Endoscopes, specifically models EG38-J10UT and EG34-J10U. The recall involves all serial numbers for these specific model numbers.
The recall was initiated 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 affected devices were distributed worldwide, including US Nationwide and International distribution, though the specific distribution status is listed as pending. The source text does not report any illnesses, injuries, or deaths associated with this recall.
The recalled product
- Product
- PENTAX Medical Ultrasound Endoscope. Model Numbers. EG38-J10UT, EG34-J10U.
- Manufacturer
- Pentax of America Inc
- Category
- Medical Device — Endoscope
- Hazard
- Affected units
- 182
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 (20)
- 1. Model No. EG38-J10UT
- UDI-DI: 04961333239474
- 04961333239481
- 04961333239498
- 04961333239504
- 04961333239528
- 04961333252770
- All Serial Numbers. 2. Model No. EG34-J10U
- UDI-DI: 04961333239672
- 04961333239689
- 04961333239696
- 04961333239702
- 04961333239726
- 04961333248834
- 04961333248841
- 04961333248858
- 04961333248872
- 04961333248896
- 04961333252732
- All Serial Numbers.
Distribution
Distributed nationwide across the United States.
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