FDA (Devices) recall action 73894

Pentax Medical Company recalled 16 products on 2016-07-06

The FDA (Devices) publishes a recall like this one as 16 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 16 pages.

Products: 16
Announced: 2016-07-06
Critical: 0
Units: 31,293

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–16 of 16

HighFDA (Devices)··2016-07-06
Pentax Laryngo Stroboscope Recalled Due to Lodged Accessories Risk
Pentax Medical Company is recalling 206 Laryngo Stroboscopes because operational and therapeutic accessories can become lodged in the instrument channel.
Product
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 introd
Category
Distribution
2 states
HighFDA (Devices)··2016-07-06
Pentax Choledocho-Nephroscope Recalled Due to Lodged Accessories in Instrument Channel
Pentax Medical is recalling 126 Choledocho-Nephroscope units because operational and therapeutic accessories can become lodged in the instrument channel.
Product
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, K
Category
Distribution
2 states
HighFDA (Devices)··2016-07-06
Pentax Choledochoscope Recall Due to Potential Instrument Channel Lodging
Pentax Medical is recalling 50 units of FCP-8P and FCP-9P choledochoscopes because accessories and therapeutic devices may become lodged in the instrument channel.
Product
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 w
Category
Distribution
2 states
HighFDA (Devices)··2016-07-06
Pentax Recalls 9,669 Gastroscope Units Due to Lodged Accessories
Pentax Medical is recalling 9,669 gastroscope units because operational or cleaning accessories can become lodged in the instrument channel.
Product
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 w
Category
Distribution
2 states
HighFDA (Devices)··2016-07-06
Pentax Medical Recalls Colonoscopes Due to Lodged Accessories
Pentax Medical is recalling 12,412 colonoscopes because operational and cleaning accessories can become lodged in the instrument channel.
Product
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 in
Category
Distribution
2 states
HighFDA (Devices)··2016-07-06
Pentax Small Bowel Scope Recall Due to Lodged Accessories
Pentax Medical Company is recalling 96 Small Bowel Scopes because operational and cleaning accessories can become lodged in the instrument channel.
Product
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 adul
Category
Distribution
2 states
HighFDA (Devices)··2016-07-06
Pentax Ultrasound Bronchoscopes Recalled for Lodged Accessories Risk
Pentax Medical is recalling 115 Ultrasound Bronchoscopes because operational and therapeutic accessories can become lodged in the instrument channel.
Product
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 acc
Category
Distribution
2 states
HighFDA (Devices)··2016-07-06
Pentax Medical Recalls Bronchoscopes Due to Lodged Accessories
Pentax Medical is recalling 4,195 bronchoscopes because operational and cleaning accessories can become lodged in the instrument channel.
Product
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
Category
Distribution
2 states
HighFDA (Devices)··2016-07-06
Pentax Intubation Scope Recall Due to Lodged Accessories in Instrument Channel
Pentax Medical Company is recalling 1,220 intubation scopes because operational and therapeutic accessories can become lodged in the instrument channel.
Product
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
Category
Distribution
2 states
HighFDA (Devices)··2016-07-06
Pentax Sigmoidoscopes Recalled Due to Risk of Lodged Accessories
Pentax Medical Company is recalling 1,596 sigmoidoscopes because operational and therapeutic accessories can become lodged in the instrument channel.
Product
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 rectu
Category
Distribution
2 states
HighFDA (Devices)··2016-07-06
Pentax Ultrasound Gastroscope Recall Due to Lodged Accessories
Pentax Medical Company is recalling ultrasound gastroscopes because operational and therapeutic accessories can become lodged in the instrument channel.
Product
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 a
Category
Distribution
2 states
HighFDA (Devices)··2016-07-06
Pentax Medical Recalls Esophagoscopes Due to Lodged Accessories Risk
Pentax Medical is recalling 405 esophagoscopes because operational accessories can become lodged in the instrument channel.
Product
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 an
Category
Distribution
2 states
HighFDA (Devices)··2016-07-06
Pentax Medical Recalls Ureteroscopes Due to Lodged Accessories Risk
Pentax Medical is recalling 32 ureteroscopes because operational accessories may become lodged in the instrument channel.
Product
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 indicati
Category
Distribution
2 states
HighFDA (Devices)··2016-07-06
Pentax Cystoscopes Recalled Due to Risk of Lodged Accessories in Instrument Channel
Pentax Medical Company is recalling 120 cystoscopes because operational and therapeutic accessories can become lodged in the instrument channel.
Product
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 consist
Category
Distribution
2 states
HighFDA (Devices)··2016-07-06
Pentax Naso-Pharyngo-Laryngoscope Recall Due to Lodged Accessories
Pentax Medical Company is recalling 215 Naso-Pharyngo-Laryngoscopes because operational and therapeutic accessories can become lodged in the instrument channel.
Product
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 th
Category
Distribution
2 states
HighFDA (Devices)··2016-07-06
Pentax Confocal GI Scope Recall Due to Lodged Accessories
Pentax Medical is recalling 17 Confocal GI Scopes because operational and therapeutic accessories can become lodged in the instrument channel.
Product
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
Category
Distribution
2 states