CLASS II ONGOING Device recall · Reported 4 Nov 2026 · FDA Enforcement Report
Pentax Medical Water bottle assembly recalled by Pentax of America
Pentax of America is recalling Pentax Medical Water bottle assembly, distributed nationwide in the US. The recall was initiated on 9 Sep 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0310-2027
- FDA event ID
- 99782
- Recalling firm
- Pentax of America, Montvale, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 9 Sep 2026
- FDA classified
- 28 Oct 2026
- Reported
- 4 Nov 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 9 Sep 2026 | Recall initiated by company | |
| 28 Oct 2026 | Classified by FDA | +49 days |
| 4 Nov 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
PENTAX Medical Water bottle assembly. Model Number. OS-H5.
Where it was distributed
Worldwide - US Nationwide and International distribution - Pending.
Questions about this recall
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.
Which lots are affected?
Model No. OS-H5; UDI-DI: 04961333219940, 04961333247486, 04961333251032, 04961333251049; All Serial Numbers.
Where was it sold?
Worldwide - US Nationwide and International distribution - Pending.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 10 Nov 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 99782This product is part of a recall event; the main page for the event is Pentax Medical Ultrasound Endoscope recalled by Pentax of America.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Pentax Medical Ultrasound Endoscope recalled by Pentax of America | Pentax of America | Sterility | Nationwide | |
| CLASS II | Pentax Medical Ultrasound Endoscope recalled by Pentax of America | Pentax of America | Sterility | Nationwide | |
| CLASS II | Pentax Medical Ultrasound Endoscope recalled by Pentax of America | Pentax of America | Sterility | Nationwide | |
| CLASS II | Pentax Medical Ultrasound Endoscope recalled by Pentax of America | Pentax of America | Sterility | Nationwide |
More recalls from Pentax of America
All 38| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Pentax Medical Ultrasound Endoscope recalled by Pentax of America | Pentax of America | Sterility | Nationwide |
| Device | CLASS II | Pentax Medical Ultrasound Endoscope recalled by Pentax of America | Pentax of America | Sterility | Nationwide |
| Device | CLASS II | Pentax Medical Ultrasound Endoscope recalled by Pentax of America | Pentax of America | Sterility | Nationwide |
| Device | CLASS II | Pentax Medical Ultrasound Endoscope recalled by Pentax of America | Pentax of America | Sterility | Nationwide |
| Device | CLASS II | Pentax Medical Video Processor recalled by Pentax of America | Pentax of America | Other | 20 states |
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