Food, drugs, devices › Pentax Medical Company
Device recall: Bronchoscope Intended to provide optical visualization of and therapeutic access to the Airway and Bronchial Tree. This
Pentax Medical Company (Montvale, NJ) initiated this device recall on 6 Apr 2016; FDA lists 16 product records under event 73894, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,232 device enforcement events initiated in 2016 carry the same class.
Status: Terminated, terminated 21 Dec 2017. Initiation: voluntary: firm initiated. Pentax Medical Company has 6 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Pentax Medical Company, Montvale, NJ.
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."
Distribution
"Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2065-2016 | 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… | 4,195 units | Class II | Terminated | 6 Jul 2016 |
| Z-2066-2016 | Choledocho-Nephroscope Intended to provide optical visualization of and therapeutic access to the Abdominal Cavity. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Biliary tree with access to the Common bile Duct, Hepatic Duct, Cystic Duct, Kidney, Renal Cavity and Renal Calyces.… | 126 units | Class II | Terminated | 6 Jul 2016 |
| Z-2067-2016 | Choledochoscope Intended to provide optical visualization of and therapeutic access to the Biliary Tree. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Common Bile, Hepatic, Cystic and Pancreatic Ducts. The instrument is introduced via the working channel of a Duodenoscope… | 50 units | Class II | Terminated | 6 Jul 2016 |
| Z-2068-2016 | Colonoscope Intended to provide optical visualization of and therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Large Bowel to the Cecum. The instrument is introduced via the rectum when indications consistent with the need for… | 12,412 units | Class II | Terminated | 6 Jul 2016 |
| Z-2069-2016 | 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… | 17 units | Class II | Terminated | 6 Jul 2016 |
| Z-2070-2016 | Cystoscope Intended to provide optical visualization of and therapeutic access to the Urinary Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Urethra to the Bladder. The instrument is introduced via the urethra when indications consistent with the need for procedure are… | 120 units | Class II | Terminated | 6 Jul 2016 |
| Z-2071-2016 | 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… | 9,669 units | Class II | Terminated | 6 Jul 2016 |
| Z-2072-2016 | Intubation Scope Intended to provide optical visualization of, therapeutic access to, and use to facilitate routine or difficult tracheal intubations of the Upper Airway. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Larynx and Trachea. The instrument is introduced via the mouth… | 1,220 units | Class II | Terminated | 6 Jul 2016 |
| Z-2073-2016 | Laryngo Stroboscope Product Usage Intended to provide optical visualization of, therapeutic access to, the Upper Airway and Vocal Folds. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Larynx, Pharynx and Vocal Cords. The instrument is introduced via the mouth or the nose, as… | 206 units | Class II | Terminated | 6 Jul 2016 |
| Z-2074-2016 | Naso-Pharyngo-Laryngoscope Intended to provide optical visualization of, therapeutic access to, the Upper Airway. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Ear, Nasal Passage and Trachea. The instrument is introduced via the mouth or the nose, as decided by the physician,… | 215 units | Class II | Terminated | 6 Jul 2016 |
| Z-2075-2016 | Signmoidoscope 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… | 1,596 units | Class II | Terminated | 6 Jul 2016 |
| Z-2076-2016 | 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 subsystems: Nasal Passage, Pharynx, Larynx, Trachea, Bronchial Tree (including access beyond the stem), and underlying… | 115 units | Class II | Terminated | 6 Jul 2016 |
| Z-2077-2016 | Ultrasound Gastroscope Intended to provide optical visualization of, ultrasonic visualization of and therapeutic access to, the Upper Gastrointestinal Track including but not restricted to organs, tissues and subsystems: Esophagus, Stomach, Duodenum, Small Bowel and underlying areas. The instrument is introduced… | 819 units | Class II | Terminated | 6 Jul 2016 |
| Z-2078-2016 | Ureteroscope Intended to provide optical visualization of and therapeutic access to the Urinary Track. This anatomy includes but is not restricted to the organs, tissues and subsystems: Urethra, Bladder and Renal Pelvis. The instrument is introduced via the urethra when indications consistent with the requirement for… | 32 units | Class II | Terminated | 6 Jul 2016 |
| Z-2079-2016 | Esophagoscope 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. | 405 units | Class II | Terminated | 6 Jul 2016 |
| Z-2080-2016 | Small Bowel Scope 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. | 96 units | Class II | Terminated | 6 Jul 2016 |
Context
Other enforcement events for Pentax Medical Company
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 6 Apr 2016 | Colonoscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Lower Gastrointest | Device | Class II | 6 |
| 22 Feb 2016 | Video Duodenoscope | Device | Class II | 1 |
| 17 Jul 2014 | PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve | Device | Class II | 1 |
| 12 Jun 2014 | EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG- | Device | Class II | 1 |
| 16 Sep 2013 | PENTAX Endoscopic Accessories. OF-B194. Made in Japan. PENTAX Upper/Lower G.I. Endoscopes are provided with Air/Water Va | Device | Class I | 1 |
All 6 events for Pentax Medical Company
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 21 Dec 2017. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.