Lower riskMedical device recall · FDA · Published July 14, 2021
Pentax Gastroscopes Recalled: Water Jet Channel Missing in Some Models
Pentax recalls certain gastroscopes made between April 2014 and May 2021 that lack a water jet channel, which could lead to improper cleaning and infection risks.
“Pentax Gastroscopes Recalled: Water Jet Channel Missing in Some Models.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62205-pentax-gastroscopes-recalled-water-jet-channel-missing-in-some-models. Based on FDA recall #Z-2449-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2449-2021%22&limit=1).
Pentax of America Inc recalled Gastroscope models EG-2790i, EG-1690K, EG-2490K, and EG-2790K on July 14, 2021, according to the FDA. The recall addresses an updated Reprocessing Instruction for Use regarding impacted PENTAX Medical Video Upper GI Scopes and Video Colonoscopes families.
How to tell if you have it
Brand: Pentax
Models: EG-2790i, EG-1690K, EG-2490K, EG-2790K, EG27-i10 (Gastroscope Family # 1)
Models: EG-2990i, EG-2990K, EG-3490K, EG29-i10 (Gastroscope Family # 2)
Model: EG-3890TK (Gastroscope Family # 3)
Units affected: 28,849
Distribution: Nationwide between April 2014 and May 2021
The hazard
The recall involves an updated Reprocessing Instruction for Use (rIFU) for impacted PENTAX Medical Video Upper GI Scopes (EG) and Video Colonoscopes (EC) families. The record does not report specific incidents or injuries associated with this update.
Context
GovInfoNow's records show Pentax of America Inc has 10 other recalls on record since July 13, 2017. Other recent recalls include a Pentax EPK-i8020c Medical Video Processor recall dated July 16, 2025, and a Pentax Medical Duodenoscope recall dated April 21, 2021. Other recent recalls of similar products include a Canon Alphenix INFX-8000H X-ray System recall dated Dec. 19, 2025, and a Philips Brilliance CT 64 Medical Scanner recall dated Aug. 7, 2026.
How to tell if you have this one
Check for model numbers EG-2790i, EG-1690K, EG-2490K, EG-2790K, or EG27-i10 (no water jet channel) or EG-2990i, EG-2990K, EG-3490K, EG29-i10 (with water jet channel) produced between April 2014 and May 2021.
Brand
Pentax
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
Nationwide
Recall number
Product, codes & lots
Z-2448-2021
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; All devices distributed by Pentax in the US between April 2014 and May 2021
Z-2449-2021
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; All devices distributed by Pentax in the US between April 2014 and May 2021
Based on the official FDA remedy
What to do — step by step
Check Model Number
Identify the model number on the device to determine if it is in the recalled list.
Contact Manufacturer
Reach out to Pentax of America Inc for guidance on next steps if the device is recalled.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2449-2021 (July 14, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2449-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.