Reported Jul 6, 2016 · Terminated
Ultrasound Bronchoscope Intended to provide optical visualization of, ultrasonic visualization of and therapeutic…
Pentax Medical Company
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Pentax Medical Company · 3 Paragon Dr · Montvale, NJ · 07645-1782
Is this the product you have?
- Ultrasound Bronchoscope Intended to provide optical visualization of, ultrasonic visualization of and therapeutic access to, the Pulmonary Tract including but not restricted to organs
- tissues and subsystemsNasal Passage, Pharynx, Larynx, Trachea, Bronchial Tree (including access beyond the stem), and underlying areas. The instrument is introduced orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations
- Lot codes and dates
- Model #EB-1970UK
- Amount recalled
- 115 units
This recall covers 16 products
The agency filed one notice per product. You are reading one of them; the other 15 are below.
3 more are in the archive.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Pentax Medical Company recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.