Pentax Medical Water Bottle Assembly Recalled for Sterile Water Warnings
Pentax of America Inc is recalling 2,972 units of the OS-H5 water bottle assembly to add warnings ensuring deaerated sterile water is used.
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. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Pentax of America Inc is recalling 2,972 units of the PENTAX Medical Water bottle assembly, Model Number OS-H5. The recall covers all serial numbers and includes specific UDI-DI codes. The product was distributed worldwide, including US Nationwide and International distribution.
The recall was initiated to add warnings to the Instructions for Use (IFU) for ultrasound endoscopes and the 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 recall. Consumers and healthcare providers should refer to the updated Instructions for Use to ensure proper use of deaerated sterile water.
The recalled product
- Product
- PENTAX Medical Water bottle assembly. Model Number. OS-H5.
- Manufacturer
- Pentax of America Inc
- Affected units
- 2,972
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 (6)
- Model No. OS-H5
- UDI-DI: 04961333219940
- 04961333247486
- 04961333251032
- 04961333251049
- All Serial Numbers.
Distribution
Distributed nationwide across the United States.
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