FDA Medical devices recall ·
PENTAX Medical Water bottle assembly recall
- Recall number
- Z-0310-2027
- Date
- (initiated September 9, 2026)
- Company / brand
- Pentax of America Inc
3 Paragon Dr, Montvale, NJ, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 2,972 units
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
PENTAX Medical Water bottle assembly. Model Number. OS-H5.
Why was it recalled?
Warnings added to the IFU for ultrasound endoscopes and water bottle assembly to ensure there is deaerated sterile water in the assembly prior to and during the procedure.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model No. OS-H5; UDI-DI: 04961333219940, 04961333247486, 04961333251032, 04961333251049; All Serial Numbers.
Distribution
Worldwide - US Nationwide and International distribution - Pending.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0310-2027. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.