CLASS II Device recall · Reported 3 Aug 2016 · FDA Enforcement Report
Signmoidoscope Product Usage: Intended to provide optical recalled
Pentax Medical is recalling Signmoidoscope Product Usage: Intended to provide optical, distributed nationwide in the US. The recall was initiated on 6 Apr 2016 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-2280-2016
- FDA event ID
- 73985
- Recalling firm
- Pentax Medical, Montvale, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Apr 2016
- FDA classified
- 22 Jul 2016
- Reported
- 3 Aug 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 6 Apr 2016 | Recall initiated by company | |
| 22 Jul 2016 | Classified by FDA | +107 days |
| 3 Aug 2016 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.
Product as listed by the FDA
Signmoidoscope Product Usage: Intended to provide optical visualization of, therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Large Bowel to the Sigmoid Colon. The instrument is introduced via the rectum when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
Where it was distributed
US Nationwide Distribution
Questions about this recall
Why was it recalled?
Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.
Which lots are affected?
Model #'s FS-34V, ES-3831, ES-3870K and ES-3840
Where was it sold?
US Nationwide Distribution
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 26 Sep 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
5 other products · FDA event 73985| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Colonoscope Product Usage: Intended to provide optical visualization recalled | Pentax Medical | Other | Nationwide | |
| CLASS II | Ultrasound Gastroscope recalled by Pentax Medical | Pentax Medical | Other | Nationwide | |
| CLASS II | Gastroscope Product Usage: Intended to provide optical visualization recalled | Pentax Medical | Other | Nationwide | |
| CLASS II | Duodenoscope Product Usage: Intended to provide optical recalled | Pentax Medical | Other | Nationwide | |
| CLASS II | Confocal GI Scope recalled by Pentax Medical | Pentax Medical | Other | Nationwide |
More recalls from Pentax Medical
All 26| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Confocal GI Scope recalled by Pentax Medical | Pentax Medical | Other | Nationwide |
| Device | CLASS II | Duodenoscope Product Usage: Intended to provide optical recalled | Pentax Medical | Other | Nationwide |
| Device | CLASS II | Gastroscope Product Usage: Intended to provide optical visualization recalled | Pentax Medical | Other | Nationwide |
| Device | CLASS II | Ultrasound Gastroscope recalled by Pentax Medical | Pentax Medical | Other | Nationwide |
| Device | CLASS II | Colonoscope Product Usage: Intended to provide optical visualization recalled | Pentax Medical | Other | Nationwide |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |