CLASS II Device recall · Reported 6 Jul 2016 · FDA Enforcement Report
Bronchoscope Intended to provide optical visualization recalled
Pentax Medical is recalling Bronchoscope 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-2065-2016
- 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
Bronchoscope Intended to provide optical visualization of and therapeutic access to the Airway and Bronchial Tree. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Nasal Passage, Trachea and Bronchial Tree. The instrument is introduced via the mouth or the nose, as decided by the physician, 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 Bronchoscope Intended to provide optical visualization of and therapeutic access to the recalled?
Yes. Pentax Medical recalled Bronchoscope 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-2065-2016.
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 FB-10V, FB015BS, FB-15P, FB-15RBS, FB-15V, FB-18BS, FB-18P, FB-18RBS, FB-18V, FB-19TV, FB-8V, EB--1530T3, EB-1170K, EB01570K, EB-1575K, EB-1970K, EB-1970-TK and EB-1975K
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.
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