Pentax of America Inc: 33 FDA recall reports
Every medical device recall the FDA has published for Pentax of America Inc. The fault, and how the agency graded it.
33Reports
0Class I
6Ongoing
2025-08-27Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Pentax Medical Video Processor; Model Number: EPK-i8020c;
Z-2329-2025 · Class II · reported 2025-08-27 · Ongoing
- Why it was recalled
- During endoscopic procedures using a combination of the video processor EPK-i8020c and i20c series video endoscope, the observed image can become reddish or dark. Users have observed smoke like steam and noted that the light guide at the tip is hot during use / after the endoscope is removed from the patient and may cause thermal injury to the patient s mucous membrane.
- Product
- Pentax Medical Video Processor; Model Number: EPK-i8020c;
- Where it went
- US Distribution to states of: AZ, CA, DC, FL IA, ID, IL, KS, MA, MD, MI, MO, NC, NJ, NM, NY, OK, PA, TX, WA.
- How much
- 144 units
Pentax Medical Video Processor- Intended to be used with PENTAX Medical endoscopes, monitors and other periphe
Z-1238-2025 · Class II · reported 2025-03-05 · Ongoing
- Why it was recalled
- During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c series video endoscope, the observed image can become reddish or dark (1.8%). Users have observed smoke-like steam and noted that the light guide at the tip is hot during use / after the endoscope is removed from the patient, and may cause thermal injury to the patient's mucous membranes.
- Product
- Pentax Medical Video Processor- Intended to be used with PENTAX Medical endoscopes, monitors and other peripheral devices for endoscopic diagnosis, treatment, and video observation. Model: EPK-i8020c
- Where it went
- Nationwide
- How much
- 94 units
PENTAX Medical Video Upper GI Scope-Intended to provide optical visualization of (via a video monitor), and th
Z-1237-2025 · Class II · reported 2025-03-05 · Ongoing
- Why it was recalled
- During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c series video endoscope, the observed image can become reddish or dark (1.8%). Users have observed smoke-like steam and noted that the light guide at the tip is hot during use / after the endoscope is removed from the patient, and may cause thermal injury to the patient's mucous membranes.
- Product
- PENTAX Medical Video Upper GI Scope-Intended to provide optical visualization of (via a video monitor), and therapeutic access to the lower gastrointestinal tract Model: EG29-i20c
- Where it went
- Nationwide
- How much
- 138 units
PENTAX Medical Video Colonoscope- Intended to provide optical visualization of (via a video monitor), and the
Z-1236-2025 · Class II · reported 2025-03-05 · Ongoing
- Why it was recalled
- During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c series video endoscope, the observed image can become reddish or dark (1.8%). Users have observed smoke-like steam and noted that the light guide at the tip is hot during use / after the endoscope is removed from the patient, and may cause thermal injury to the patient's mucous membranes.
- Product
- PENTAX Medical Video Colonoscope- Intended to provide optical visualization of (via a video monitor), and therapeutic access to the lower gastrointestinal tract Model: EC38-i20cL
- Where it went
- Nationwide
- How much
- 152 units
Gastroscope Family # 1-Gastroscopes without a Water Jet Channel Models: EG-2790i, EG-1690K, EG-2490K, EG-2790K
Z-2449-2021 · Class II · reported 2021-09-22 · Ongoing
- Why it was recalled
- Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Video Upper GI Scopes (EG) and Video Colonoscopes (EC) families
- Product
- Gastroscope Family # 1-Gastroscopes without a Water Jet Channel Models: EG-2790i, EG-1690K, EG-2490K, EG-2790K, EG27-i10; Gastroscope Family # 2- Gastroscopes with a Water Jet Channel Models: EG-2990i, EG-2990K, EG-3490K, EG29-i10; Gastroscope Family # 3-Gastroscopes with Two Instrument Channels and a Water Jet Channel Models: EG-3890TK
- Where it went
- Nationwide
- How much
- 28849 units Total
Colonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One Instrument Channel and a Water Jet Chann
Z-2448-2021 · Class II · reported 2021-09-22 · Ongoing
- Why it was recalled
- Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Video Upper GI Scopes (EG) and Video Colonoscopes (EC) families
- Product
- Colonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One Instrument Channel and a Water Jet Channel Models: EC-2990Li, EC-3490Li, EC-3890Li, EC-3490TLi, EC-3490LK, EC-3890LK, EC3890LZi, EC34-i10L, EC38-i10L; Colonoscope Family # 2-Pentax Video Colonoscopes with Two Instrument Channels and a Water Jet Channel Model: EC-3890TLK
- Where it went
- Nationwide
- How much
- 28849 units Total
Pentax Medical Video Duodenoscope - Product Usage: intended to be used with endoscopic devices and other ancil
Z-1682-2021 · Class II · reported 2021-06-02 · Terminated
- Why it was recalled
- IFU updated: The warning section of the IFU for both the OE-A63 distal end cap and ED34-i10T2 duodenoscope has been updated to notify users of the associated risks with the distal end cap (OE-A63) unexpectedly becoming detached during a procedure and updated to notify users of what immediate actions should be taken in case the event occurs. This can result in unforseen events such as mucosal injury, lacerations, or bleeding of the patient. Detachment of the distal end cap (OE-A63) into the oral cavity of the patient may also result in aspiration
- Product
- Pentax Medical Video Duodenoscope - Product Usage: intended to be used with endoscopic devices and other ancillary equipment to provide optical visualization of (via a video monitor), and therapeutic access to, Biliary Tract via the Upper Gastrointestinal Tract, Model Number: ED34-i10T2.
- Where it went
- US Nationwide distribution in the states of Alabama, California, Louisiana, Maryland, Michigan, Missouri, New Jersey, North Carolina, Pennsylvania, Texas, Washington, D.C.
- How much
- 108 units
9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal),
Z-0292-2021 · Class II · reported 2020-11-04 · Terminated
- Why it was recalled
- There is an intermittent software issue that could affect the systems, in which an exam video for one patient (Patient A) might be copied to another patient (Patient B). This does not occur at the time the user performs and initially reviews an exam; it is not evident until a follow-up review occurs.
- Product
- 9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal),
- Where it went
- US Nationwide and Canada
- How much
- 39 total
9310HD Digital Video Capture Module with software version 3.4.0 or higher configured with 9263 endoPortal
Z-0293-2021 · Class II · reported 2020-11-04 · Terminated
- Why it was recalled
- There is an intermittent software issue that could affect the systems, in which an exam video for one patient (Patient A) might be copied to another patient (Patient B). This does not occur at the time the user performs and initially reviews an exam; it is not evident until a follow-up review occurs.
- Product
- 9310HD Digital Video Capture Module with software version 3.4.0 or higher configured with 9263 endoPortal
- Where it went
- US Nationwide and Canada
- How much
- 39 total
Pentax Video Colonoscope Model: EC38-i10L
Z-1268-2020 · Class II · reported 2020-02-26 · Terminated
- Why it was recalled
- Distributed in the USA without an approved 510K
- Product
- Pentax Video Colonoscope Model: EC38-i10L
- Where it went
- NC, MA
- How much
- 1 unit
Pentax Video Colonoscope Model: EC34-i10L
Z-1267-2020 · Class II · reported 2020-02-26 · Terminated
- Why it was recalled
- Distributed in the USA without an approved 510K
- Product
- Pentax Video Colonoscope Model: EC34-i10L
- Where it went
- NC, MA
Pentax Medical C2 CryoBalloon Standard Focal Catheter, Model FG 1028, Sterile, RX. Product Usage: The C2 C
Z-1325-2019 · Class II · reported 2019-05-22 · Terminated
- Why it was recalled
- Incorrect default dose and dose increments may be transmitted to the controller if the catheter RFID tag is not correct or is not being correctly or completely readable by the controller.
- Product
- Pentax Medical C2 CryoBalloon Standard Focal Catheter, Model FG 1028, Sterile, RX. Product Usage: The C2 CryoBalloon Ablation System is intended to be used as a cryosurgical tool in the field of general surgery, specifically for endoscopic application and the ablation of dysplastic Barrett s Esophagus. The system includes the following components: (1) CryoBalloon Catheter connects to the Controller, which controls the operation of the Catheter such as diffuser (sprayer) positioning and ablation (nitrous oxide release); (2) CryoBalloon Controller contains the cartridge heater and cryogen delivery valve, which is controlled with the foot pedal; (3) Foot Pedal; and (4) CryoBalloon Cartridge containing 36 grams of nitrous oxide.
- Where it went
- Distribution was made to CA, DC, FL, LA, MA, MD, MN, NC, NJ, NY, OH, PA, SC, TN, TX, VA, and WA. There was no government/military distribution. Foreign distribution was made to Canada, Germany, and the Netherlands.
- How much
- 157 devices
Pentax Medical C2 CryoBalloon Pear Focal Catheter, Model FG 1024, Sterile, RX. Product Usage: The C2 CryoB
Z-1326-2019 · Class II · reported 2019-05-22 · Terminated
- Why it was recalled
- Incorrect default dose and dose increments may be transmitted to the controller if the catheter RFID tag is not correct or is not being correctly or completely readable by the controller.
- Product
- Pentax Medical C2 CryoBalloon Pear Focal Catheter, Model FG 1024, Sterile, RX. Product Usage: The C2 CryoBalloon Ablation System is intended to be used as a cryosurgical tool in the field of general surgery, specifically for endoscopic application and the ablation of dysplastic Barrett s Esophagus. The system includes the following components: (1) CryoBalloon Catheter connects to the Controller, which controls the operation of the Catheter such as diffuser (sprayer) positioning and ablation (nitrous oxide release); (2) CryoBalloon Controller contains the cartridge heater and cryogen delivery valve, which is controlled with the foot pedal; (3) Foot Pedal; and (4) CryoBalloon Cartridge containing 36 grams of nitrous oxide.
- Where it went
- Distribution was made to CA, DC, FL, LA, MA, MD, MN, NC, NJ, NY, OH, PA, SC, TN, TX, VA, and WA. There was no government/military distribution. Foreign distribution was made to Canada, Germany, and the Netherlands.
- How much
- 68 devices
Pentax Medical C2 CryoBalloon Standard 90 degree Catheter, Model FG 1030, Sterile, RX. Product Usage: The
Z-1327-2019 · Class II · reported 2019-05-22 · Terminated
- Why it was recalled
- Incorrect default dose and dose increments may be transmitted to the controller if the catheter RFID tag is not correct or is not being correctly or completely readable by the controller.
- Product
- Pentax Medical C2 CryoBalloon Standard 90 degree Catheter, Model FG 1030, Sterile, RX. Product Usage: The C2 CryoBalloon Ablation System is intended to be used as a cryosurgical tool in the field of general surgery, specifically for endoscopic application and the ablation of dysplastic Barrett s Esophagus. The system includes the following components: (1) CryoBalloon Catheter connects to the Controller, which controls the operation of the Catheter such as diffuser (sprayer) positioning and ablation (nitrous oxide release); (2) CryoBalloon Controller contains the cartridge heater and cryogen delivery valve, which is controlled with the foot pedal; (3) Foot Pedal; and (4) CryoBalloon Cartridge containing 36 grams of nitrous oxide.
- Where it went
- Distribution was made to CA, DC, FL, LA, MA, MD, MN, NC, NJ, NY, OH, PA, SC, TN, TX, VA, and WA. There was no government/military distribution. Foreign distribution was made to Canada, Germany, and the Netherlands.
- How much
- 4 devices
C2 CryoBalloon Controller, REF: FG-1017, with Controller Software v1.18.258 The C2 CryoBalloon Ablation Sys
Z-0970-2019 · Class II · reported 2019-03-13 · Terminated
- Why it was recalled
- The Controller does not detect overpressure in the balloon during the application of non-dosing puffs of Nitrous Oxide, which can contribute to balloon over pressurization, if the intended vent lumen of the catheter is significantly occluded to prevent relieving balloon pressure due to a kinked catheter condition.If a patient is exposed to higher than physiologic pressures, adverse events such as perforation or mucosal laceration may occur.
- Product
- C2 CryoBalloon Controller, REF: FG-1017, with Controller Software v1.18.258 The C2 CryoBalloon Ablation System is intended to be used as a cryosurgical tool in the field of general surgery, specifically for endoscopic application and the ablation of dysplastic Barrett s Esophagus.
- Where it went
- Worldwide Distribution: US (nationwide) to states of:: CA, DC, FL, LA, MA, MD, MN, NC, NJ, NY, OH, PA, SC, TN, TX, VA, WA;; and countries: Canada, Germany, and Netherlands.
- How much
- 45
C2 CryoBalloon Focal Catheter, REF FG-1009. C2 CryoBalloon Ablation System is used as a cryosurgical tool in
Z-2256-2018 · Class II · reported 2018-06-27 · Terminated
- Why it was recalled
- The catheter alignment arrow printed onto the strain relief is not aligned with the detachment feature of the catheter connector, resulting in the potential for the catheter to be attached to the controller in the detach orientation. In this orientation, the catheter is not securely attached to the controller and may be partially (~1cm) ejected from controller.
- Product
- C2 CryoBalloon Focal Catheter, REF FG-1009. C2 CryoBalloon Ablation System is used as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications.
- Where it went
- Distribution US nationwide.
- How much
- 57 units
Pentax Video Duodenoscope Model: ED-3490TK (UDI of design being recalled: 04961333232420) These instrumen
Z-0643-2018 · Class II · reported 2018-02-28 · Terminated
- Why it was recalled
- The duodenoscopes are being recalled in order to replace the forceps elevator mechanism, the O-rings, and the distal end covering to be consistent with the updated design as well as provide an updated periodic inspection as part of the Operation Manual in order to mitigate the potential risk of infection in flexible endoscopy.
- Product
- Pentax Video Duodenoscope Model: ED-3490TK (UDI of design being recalled: 04961333232420) These instruments are intended to provide optical visualization of (via a video monitor), and therapeutic access to, the biliary tract via the upper GI tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: esophagus, stomach, duodenum, common bile, hepatic, and cystic ducts.
- Where it went
- USA (nationwide) Distribution to the states of including Puerto Rico : AL, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NV, NY, OH, OK, PA, TN, TX, UT, VA, WA, WI, WV and WY, and the District of Columbia.
- How much
- 559
Video Cystoscope models ECY-1570 and ECY-1570K
Z-0615-2018 · Class II · reported 2018-02-21 · Terminated
- Why it was recalled
- The video cytoscopes lack 510(k) premarket notification clearance.
- Product
- Video Cystoscope models ECY-1570 and ECY-1570K
- Where it went
- Distributed in 8 states: CA, IL, MD, MI, ND, NH, NY, SD, and Guam.
- How much
- 24
Ultrasound Video Gastroscope, Model EG-3670URK, The product is intended to be used in combination with the
Z-3067-2017 · Class II · reported 2017-08-30 · Terminated
- Why it was recalled
- Error in reprocessing instructions in Revisions 13 and 14 of IFU Z845, used with EG-3670URK and EG-3870UTK ultrasound gastroscopes. In the disinfection step, the IFU has a warning indicating the cleaning detergent solution should remain in contact with the all internal channels and external endoscope surfaces. The disinfecting solution, not the cleaning detergent, should be used for this step.
- Product
- Ultrasound Video Gastroscope, Model EG-3670URK, The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of the upper gastrointestinal tract from esophagus through duodenum.
- Where it went
- Nationwide
- How much
- US: 118 units
Ultrasound Video Gastroscope, Model EG-3870UTK. The product is intended to be used in combination with the
Z-3068-2017 · Class II · reported 2017-08-30 · Terminated
- Why it was recalled
- Error in reprocessing instructions in Revisions 13 and 14 of IFU Z845, used with EG-3670URK and EG-3870UTK ultrasound gastroscopes. In the disinfection step, the IFU has a warning indicating the cleaning detergent solution should remain in contact with the all internal channels and external endoscope surfaces. The disinfecting solution, not the cleaning detergent, should be used for this step.
- Product
- Ultrasound Video Gastroscope, Model EG-3870UTK. The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of the upper gastrointestinal tract from esophagus through duodenum.
- Where it went
- Nationwide
- How much
- US: 116 units
9400 Laryngeal Strobe Product Usage: The 9310HD is used to electronically record, display, transfer, and
Z-2744-2017 · Class II · reported 2017-07-26 · Terminated
- Why it was recalled
- Pentax Medical did not always provide transformers with 9175 isolation transformers are used with 7245C, 7245C/E, 7245D, 9200Cs, 9200Ds, 9310HDs, and 9400s computer systems.
- Product
- 9400 Laryngeal Strobe Product Usage: The 9310HD is used to electronically record, display, transfer, and store digital video data of laryngeal or pharyngeal structures, and audio data, for medical and pedagogical applications.
- Where it went
- Worldwide Distribution - US Nationwide
- How much
- 241 units in total
9200C and 9200D Laryngeal Strobe Product Usage: The 9310HD is used to electronically record, display, tra
Z-2745-2017 · Class II · reported 2017-07-26 · Terminated
- Why it was recalled
- Pentax Medical did not always provide transformers with 9175 isolation transformers are used with 7245C, 7245C/E, 7245D, 9200Cs, 9200Ds, 9310HDs, and 9400s computer systems.
- Product
- 9200C and 9200D Laryngeal Strobe Product Usage: The 9310HD is used to electronically record, display, transfer, and store digital video data of laryngeal or pharyngeal structures, and audio data, for medical and pedagogical applications.
- Where it went
- Worldwide Distribution - US Nationwide
- How much
- 241 units in total
7245C, 7245C/E, 7245D Computer Digital Video System Product Usage: The 7245C, 7245C/E and 7245D are used
Z-2742-2017 · Class II · reported 2017-07-26 · Terminated
- Why it was recalled
- Pentax Medical did not always provide transformers with 9175 isolation transformers are used with 7245C, 7245C/E, 7245D, 9200Cs, 9200Ds, 9310HDs, and 9400s computer systems.
- Product
- 7245C, 7245C/E, 7245D Computer Digital Video System Product Usage: The 7245C, 7245C/E and 7245D are used to electronically record, display, transfer, and store digital video data of behavior related to swallowing in the pharyngeal area for medical and pedagogical applications.
- Where it went
- Worldwide Distribution - US Nationwide
- How much
- 241 units in total
9310HD Digital Video Capture Modules Product Usage: The 9310HD is used to electronically record, display,
Z-2743-2017 · Class II · reported 2017-07-26 · Terminated
- Why it was recalled
- Pentax Medical did not always provide transformers with 9175 isolation transformers are used with 7245C, 7245C/E, 7245D, 9200Cs, 9200Ds, 9310HDs, and 9400s computer systems.
- Product
- 9310HD Digital Video Capture Modules Product Usage: The 9310HD is used to electronically record, display, transfer, and store digital video data of laryngeal or pharyngeal structures, and audio data, for medical and pedagogical applications.
- Where it went
- Worldwide Distribution - US Nationwide
- How much
- 241 units in total
Video Duodenoscope These instruments are intended to provide optical visualization of (via a video monitor)
Z-2713-2017 · Class II · reported 2017-07-19 · Terminated
- Why it was recalled
- Pentax initiated a field correction/safety alert for two (2) models of the Video Duodenoscope to determine how soiling may have occurred on the surface of the suction cylinder and under the distal cap during testing.
- Product
- Video Duodenoscope These instruments are intended to provide optical visualization of (via a video monitor), and therapeutic access to, the biliary tract via the upper GI tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: esophagus, stomach, duodenum, common bile, hepatic and cystic ducts.
- Where it went
- Worldwide Distribution-US (Nationwide) including states of: AL, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NH, NJ, NV, NY, OH, OK, PA, PR, TN, TX, UT, VA, WA, WI, WV, WY;. and country of: CANADA.
- How much
- 2,015 (US - 519 (ED-3490TK) and 5 (ED-3270K); OUS - 1,491)
Video Cytoscopes
Z-2325-2017 · Class II · reported 2017-06-21 · Terminated
- Why it was recalled
- This field action serves to retrospectively document the actions that were taken by Pentax to correct the loose suction arms on eleven (11) models of endoscopes and to notify FDA of these actions taken in 2010-2011.
- Product
- Video Cytoscopes
- Where it went
- US Nationwide and Internationally
- How much
- 1,349 - (Total - US) and 352 (Total - OUS)
Video Bronchoscope
Z-2324-2017 · Class II · reported 2017-06-21 · Terminated
- Why it was recalled
- This field action serves to retrospectively document the actions that were taken by Pentax to correct the loose suction arms on eleven (11) models of endoscopes and to notify FDA of these actions taken in 2010-2011.
- Product
- Video Bronchoscope
- Where it went
- US Nationwide and Internationally
- How much
- 1,349 - (Total - US) and 352 (Total - OUS)
Video Naso pharyngo Laryngoscopes
Z-2326-2017 · Class II · reported 2017-06-21 · Terminated
- Why it was recalled
- This field action serves to retrospectively document the actions that were taken by Pentax to correct the loose suction arms on eleven (11) models of endoscopes and to notify FDA of these actions taken in 2010-2011.
- Product
- Video Naso pharyngo Laryngoscopes
- Where it went
- US Nationwide and Internationally
- How much
- 1,349 - (Total - US) and 352 (Total - OUS)
Rigid Laryngostroboscopes The Rigid Laryngostroboscopes, Models 9106 and 9108 are intended to observe glott
Z-1075-2017 · Class II · reported 2017-02-01 · Terminated
- Why it was recalled
- Pentax is initiating a Field Correction to revise the Instructions for Use of the Rigid Laryngostroboscopes Model 9106 and 9108.
- Product
- Rigid Laryngostroboscopes The Rigid Laryngostroboscopes, Models 9106 and 9108 are intended to observe glottic action with the use of a stroboscopic light source. The instrument is inserted per-orally when indications consistent with the need for observation are observed.
- Where it went
- Worldwide Distribution-US (nationwide) and countries of: Albania, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, Croatia, Denmark, Ecuador, Egypt, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Oman, Philippines, Portugal, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand, Trinidad, Turkey, United Arab Emirates, and United Kingdom.
- How much
- 2,056 (1,545 (US) and 511 (OUS))
Ultrasound Video Bronchoscope The EB-1970UK, Ultrasound Video Bronchoscope, is intended to provide optical v
Z-0757-2017 · Class II · reported 2016-12-21 · Terminated
- Why it was recalled
- The EB-1970UK Ultrasound Video Bronchoscope shipped between the clearance date of April 2014 and September 2015 contained the Operation and Reprocessing IFUs that were in use prior to the 2014 clearance, and therefore did not include the cleared Operation and Reprocessing IFUs.
- Product
- Ultrasound Video Bronchoscope The EB-1970UK, Ultrasound Video Bronchoscope, is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Pulmonary Track including but not restricted to organs, tissues, and subsystem: Nasal Passage, Pharynx, Larynx, Trachea, Bronchial Tree (including access beyond the stem), and underlying areas. The instrument is introduced per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.
- Where it went
- Nationwide Distribution
- How much
- 113 units
Showing the 30 most recent of 33. The rest are searchable at the FDA enforcement report database.
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
← All device recalls