CLASS II Device recall · Reported 6 Jul 2016 · FDA Enforcement Report
Gastroscope Intended to provide optical visualization recalled
Pentax Medical is recalling Gastroscope Intended to provide optical visualization of and therapeutic access to the, 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-2071-2016
- 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
Gastroscope Intended to provide optical visualization of and therapeutic access to the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Esophagus, Stomach and Duodenum. The instrument is introduced via the mouth 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
Is Gastroscope Intended to provide optical visualization of and therapeutic access to the recalled?
Yes. Pentax Medical recalled Gastroscope Intended to provide optical visualization of and therapeutic access to the on 6 Apr 2016. The recall is Class II and its status is Terminated. Recall number Z-2071-2016.
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 FG-16V, FG-24V, FG-29V, EG-1540, EG-1580K, EG1840, EG-2540, EG-2940, EG-3840T, EG-3831T, EG-3870TK, EG-1870K, EG-2470K, EG-2530, EG-2730K, EG-2731, EG-2770K, EG-290KP, EG-2930K, EG-2931, EG-2931K, EG-2970K, EG-3430Z, EG-3470K, EG-3470ZK, EG-1690K, EG-2490K, EG-2790I, EG-2790K, EG27-I10, EG-2990I, EG-2990K, EG29-I10, EG-3490K and EG-3890TK
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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 |
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| 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 |