Pentax Video Duodenoscope Recalled to Mitigate Infection Risk
Pentax of America Inc is recalling 559 Video Duodenoscopes to replace specific components and update inspection protocols to mitigate the potential risk of infection.
The agency’s classification
FDA (Devices): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall addresses a 'potential risk of infection' in a medical device without reported illnesses or injuries, which aligns with the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Pentax of America Inc is recalling 559 units of the Pentax Video Duodenoscope, Model ED-3490TK. These instruments are intended to provide optical visualization and therapeutic access to the biliary tract via the upper GI tract. The recall covers all serial numbers of the affected design.
The recall is being conducted to replace the forceps elevator mechanism, O-rings, and distal end covering to align with an updated design. Additionally, the recall includes providing an updated periodic inspection protocol as part of the Operation Manual. These measures are intended to mitigate the potential risk of infection associated with flexible endoscopy.
The affected devices were distributed nationwide in the United States, including Puerto Rico and the District of Columbia. Specific states listed include 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. Users should contact Pentax of America Inc for instructions on replacing the components and updating their inspection procedures.
The recalled product
- 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…
- Manufacturer
- Pentax of America Inc
- Category
- Medical Device — Endoscopy
- Hazard
- Affected units
- 559
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Serial Numbers
Distribution
Related recalls
Same manufacturer · Pentax of America Inc
See all →- HighEndoscopy video processors recalled over hot light guide and thermal injury risk
FDA (Devices) · 2025-08-27
- HighVideo Colonoscope May Cause Thermal Burns to Tissue During Use
FDA (Devices) · 2025-03-05
- HighPENTAX Medical Video Upper GI Endoscope Thermal Burn Risk Recall
FDA (Devices) · 2025-03-05
- HighPentax EPK-i8020c Video Processor Recalled for Thermal Burn Risk
FDA (Devices) · 2025-03-05
- HighPentax Upper GI Endoscopes and Colonoscopes: Updated Reprocessing Instructions
FDA (Devices) · 2021-09-22
Same hazard · infection
See all →- SevereStryker Bard EP XT Decapolar Steerable Diagnostic EP Catheter Recalled for Sterile Barrier Breach
FDA (Devices) · 2026-10-14
- SevereSafeguard US Operating LLC Recalls Compression Bandages Due to Degradation
FDA (Devices) · 2026-10-14
- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- HighFDA Recalls Performance Pro Nitrile Gloves Due to Defects
FDA (Devices) · 2026-10-07
- SevereAurolab Trust Recalls FOCUS PI Eye Drops Due to Sterility Concerns
FDA (Drugs) · 2026-10-07
Similar recalls
- HighPentax Medical Video Duodenoscope Recalled for Distal End Cap Detachment Risk
FDA (Devices) · 2021-06-02
- HighPentax Video Duodenoscope Recall for Surface Soiling Investigation
FDA (Devices) · 2017-07-19
- ModeratePentax Video Gastroscope Recall for Updated Operation and Reprocessing Instructions
FDA (Devices) · 2016-11-02
- ModeratePentax Video Colonoscope Recall for Missing Operation and Reprocessing Instructions
FDA (Devices) · 2016-11-30
- ModerateFujifilm Medical Systems Recalls Duodenoscopes for Reprocessing Design Changes
FDA (Devices) · 2015-12-23
- ModeratePentax Video Bronchoscopes Recalled for Loose Suction Arms
FDA (Devices) · 2017-06-21