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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 73894

16 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 06, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Pentax Medical Company

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

16 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 16

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.

Z-2065-2016
Recall number
Z-2065-2016
Initiated
April 06, 2016
Classification
Class II
Status
Terminated
Recalling firm
Pentax Medical Company
Quantity
4,195 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam

device · product 2 of 16

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. The instrument is introduced via percutaneous cut when indications consistent with the need for procedure are observed in adult and pediatric patient populations.

Z-2066-2016
Recall number
Z-2066-2016
Initiated
April 06, 2016
Classification
Class II
Status
Terminated
Recalling firm
Pentax Medical Company
Quantity
126 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Model #'s ECN-1530 and FCN-15X

Distribution pattern

Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam

device · product 3 of 16

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 positioned for access to the Common bile Duct when indications consistent with the need for procedure are observed in adult and pediatric patient populations.

Z-2067-2016
Recall number
Z-2067-2016
Initiated
April 06, 2016
Classification
Class II
Status
Terminated
Recalling firm
Pentax Medical Company
Quantity
50 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Model #'s FCP-8P and FCP-9P

Distribution pattern

Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam

device · product 4 of 16

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 procedure are observed in adult and pediatric patient populations.

Z-2068-2016
Recall number
Z-2068-2016
Initiated
April 06, 2016
Classification
Class II
Status
Terminated
Recalling firm
Pentax Medical Company
Quantity
12,412 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Model #'s EC-3430L, EC-3430LK, EC-3470LK, EC-380LKP, EC-3830LK, EC-3930LZ, EC-3831L, EC-3832L, EC-3832LK, EC-3870LK, EC-3870LZK, EC-3872LK, FC-38LV, EC-3830TLK, EC-3832TL, EC-3870TLK, EC-3872TLK, EC-3440L, EC-3840K, EC-2990LI, EC-3490LI, EC-3490LK, EC-3490TLI, EC34-I10L, EC-3890LI, EC-3890LK, EC-3890TLK and EC38-I10L

Distribution pattern

Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam

device · product 5 of 16

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 as decided by the anatomy being accessed when indications consistent with the need for procedure are observed in adult and pediatric patient populations.

Z-2069-2016
Recall number
Z-2069-2016
Initiated
April 06, 2016
Classification
Class II
Status
Terminated
Recalling firm
Pentax Medical Company
Quantity
17 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Model #'s EG-3870CIK, EC-3870CILK

Distribution pattern

Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam

device · product 6 of 16

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 observed in adult and pediatric patient populations.

Z-2070-2016
Recall number
Z-2070-2016
Initiated
April 06, 2016
Classification
Class II
Status
Terminated
Recalling firm
Pentax Medical Company
Quantity
120 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Model #'s ECY-1530, ECY-1570K, FCY-15P2 and FCY-15RBS

Distribution pattern

Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam

device · product 7 of 16

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.

Z-2071-2016
Recall number
Z-2071-2016
Initiated
April 06, 2016
Classification
Class II
Status
Terminated
Recalling firm
Pentax Medical Company
Quantity
9,669 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam

device · product 8 of 16

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 or the nose, as decided by the physician, when indications consistent with the need for procedure are observed in adult and pediatric patient populations.

Z-2072-2016
Recall number
Z-2072-2016
Initiated
April 06, 2016
Classification
Class II
Status
Terminated
Recalling firm
Pentax Medical Company
Quantity
1,220 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Model #'s FI-10BS, FI-10P2, FI-10RBS, FI-13BS, FI-13P, FI-13RBS, FI-16BS, FI-16RBS, FI-9BS and FI-9RBS

Distribution pattern

Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam

device · product 9 of 16

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 decided by the physician, when indications consistent with the need for procedure are observed in adult and pediatric patient populations.

Z-2073-2016
Recall number
Z-2073-2016
Initiated
April 06, 2016
Classification
Class II
Status
Terminated
Recalling firm
Pentax Medical Company
Quantity
206 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Model #VNL-1570STK

Distribution pattern

Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam

device · product 10 of 16

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, when indications consistent with the need for procedure are observed in adult and pediatric patient populations

Z-2074-2016
Recall number
Z-2074-2016
Initiated
April 06, 2016
Classification
Class II
Status
Terminated
Recalling firm
Pentax Medical Company
Quantity
215 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Model #'s FNL-10RAP, FNL-13RAP, FNL-15RP3 and VNL-1530T

Distribution pattern

Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam

device · product 11 of 16

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 need for procedure are observed in adult and pediatric patient populations

Z-2075-2016
Recall number
Z-2075-2016
Initiated
April 06, 2016
Classification
Class II
Status
Terminated
Recalling firm
Pentax Medical Company
Quantity
1,596 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Model #'s FS-34V, ES-3831, ES-3870K and ES-3840

Distribution pattern

Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam

device · product 12 of 16

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 areas. The instrument is introduced orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations

Z-2076-2016
Recall number
Z-2076-2016
Initiated
April 06, 2016
Classification
Class II
Status
Terminated
Recalling firm
Pentax Medical Company
Quantity
115 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Model #EB-1970UK

Distribution pattern

Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam

device · product 13 of 16

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 orally when indications consistent with the requirement for procedure are observed in adult and pediatric

Z-2077-2016
Recall number
Z-2077-2016
Initiated
April 06, 2016
Classification
Class II
Status
Terminated
Recalling firm
Pentax Medical Company
Quantity
819 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Model #'s EG-3630U, EG-3630UR, EG-3670URK, EG-3830UT, EG-3870UTK, FG-34UX, FG-36UX and FG-38UX

Distribution pattern

Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam

device · product 14 of 16

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 procedure are observed in adult and pediatric patient populations.

Z-2078-2016
Recall number
Z-2078-2016
Initiated
April 06, 2016
Classification
Class II
Status
Terminated
Recalling firm
Pentax Medical Company
Quantity
32 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Model #'s FUR-9P and FUR-9RBS

Distribution pattern

Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam

device · product 15 of 16

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.

Z-2079-2016
Recall number
Z-2079-2016
Initiated
April 06, 2016
Classification
Class II
Status
Terminated
Recalling firm
Pentax Medical Company
Quantity
405 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Model #'s EE-1540 and EE-1580k

Distribution pattern

Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam

device · product 16 of 16

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.

Z-2080-2016
Recall number
Z-2080-2016
Initiated
April 06, 2016
Classification
Class II
Status
Terminated
Recalling firm
Pentax Medical Company
Quantity
96 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Model #VSB-3430

Distribution pattern

Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam