Exact FDA event identifier

Event 73985

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

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

6 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 6

Colonoscope Product Usage: 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-2275-2016

Recall number: Z-2275-2016
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 Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.

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 Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.

Code information

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

Distribution pattern

US Nationwide Distribution

device · product 2 of 6

Confocal GI Scope Product Usage: Intended to provide optical visualization of and therapeutic access to the Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, and Large Bowel to the Cecum. The instrument is introduced via the mouth or rectum as decided by the the anatomy being accessed when indications consistent with the need for procedure are observed in adult and pediatric patient populations.

Z-2276-2016

Recall number: Z-2276-2016
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 Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.

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 Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.

Code information

Model #'s EG-3870CIK and EC-3870CIK

Distribution pattern

US Nationwide Distribution

device · product 3 of 6

Duodenoscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, and Large Bowel to the Cecum. The instrument is introduced via the mouth or rectum as decided by the the anatomy being accessed when indications consistent with the need for procedure are observed in adult and pediatric patient populations.

Z-2277-2016

Recall number: Z-2277-2016
Initiated: April 06, 2016
Classification: Class II
Status: Terminated
Recalling firm: Pentax Medical Company
Quantity: 433 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.

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 Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.

Code information

Model #'s FD-34V and ED-3490TK

Distribution pattern

US Nationwide Distribution

device · product 4 of 6

Gastroscope Product Usage: 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-2278-2016

Recall number: Z-2278-2016
Initiated: April 06, 2016
Classification: Class II
Status: Terminated
Recalling firm: Pentax Medical Company
Quantity: 10,074 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.

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 Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.

Code information

Model #'s FG-16V, FG-24V, FG-29V, EE-1540, EE-1580K, EG-1540, EG-1580K, EG-1840, 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, VSB-3430K, EG-1690K, EG-2490K, EG-2790I, EG-2790K, EG27-I10, EG-2990I, EG-2990K, EG29-I10, EG-3490K and EG-3890TK.

Distribution pattern

US Nationwide Distribution

device · product 5 of 6

Ultrasound Gastroscope Product Usage: Intended to provide optical visualization of, ultrasonic Visualization of, and therapeutic access to the Upper Gastrointestinal Tract including but not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, Small Bowel and underlying areas. The instrument is introduced via per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.

Z-2279-2016

Recall number: Z-2279-2016
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 Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.

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 Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.

Code information

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

Distribution pattern

US Nationwide Distribution

device · product 6 of 6

Signmoidoscope Product Usage: 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-2280-2016

Recall number: Z-2280-2016
Initiated: April 06, 2016
Classification: Class II
Status: Terminated
Recalling firm: Pentax Medical Company
Quantity: N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.

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 Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.

Code information

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

Distribution pattern

US Nationwide Distribution