CLASS II Device recall · Reported 6 Jul 2016 · FDA Enforcement Report
Confocal GI Scope Intended to provide optical visualization recalled
Pentax Medical is recalling Confocal GI Scope Intended to provide optical visualization of an therapeutic access to, distributed in Puerto Rico. 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-2069-2016
- FDA event ID
- 73894
- Recalling firm
- Pentax Medical, Montvale, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Apr 2016
- FDA classified
- 28 Jun 2016
- Reported
- 6 Jul 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 | |
| 28 Jun 2016 | Classified by FDA | +83 days |
| 6 Jul 2016 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.
Product as listed by the FDA
Confocal GI Scope Intended to provide optical visualization of an therapeutic access to the Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Esophagus, Stomach and Duodenum, and Large Bowel to the Cecum. The instrument is introduced via the mouth or rectum as decided by the anatomy being accessed when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
Where it was distributed
Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam
Questions about this recall
Why was it recalled?
Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.
Which lots are affected?
Model #'s EG-3870CIK, EC-3870CILK
Where was it sold?
Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam
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
15 other products · FDA event 73894This product is part of a recall event; the main page for the event is Bronchoscope Intended to provide optical visualization recalled.
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 |