UnratedMedical device recall · FDA · Published January 3, 2020
Pentax EC38-i10L Colonoscope Recall: Missing FDA Approval
Pentax recalls EC38-i10L colonoscopes sold without FDA approval. Affected units lack required safety clearance. Consumers should contact manufacturer for details.
“Pentax EC38-i10L Colonoscope Recall: Missing FDA Approval.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/66172-pentax-ec38-i10l-colonoscope-recall-missing-fda-approval. Based on FDA recall #Z-1268-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1268-2020%22&limit=1).
The FDA announced on Jan. 3, 2020, that Pentax of America Inc recalled one Pentax Video Colonoscope Model EC38-i10L because it was distributed in the USA without an approved 510(k).
How to tell if you have it
Brand: Pentax
Product: Video Colonoscope
Model: EC38-i10L
Serial Number: L110746
Quantity: 1 unit
Distribution: NC, MA
The hazard
The device was distributed in the USA without an approved 510(k).
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 on July 16, 2025, and a Pentax Medical Colonoscope recall on Jan. 29, 2025. Other recent recalls of similar products include a Covidien Mon-a-Therm Stethoscope recall (April 23, 2026), a Siemens SOMATOM X.ceed Software Applications recall (Dec. 19, 2025), and a Medline Angiography Kits recall (Feb. 25, 2026).
How to tell if you have this one
Check for model EC38-i10L and serial numbers L110746 on the device. These colonoscopes were sold in the US without FDA clearance.
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
Terminated
Distribution
NC, MA
Recall number
Product, codes & lots
Quantity
Z-1267-2020
Pentax Video Colonoscope Model: EC34-i10L; Serial Numbers: L110300, L110301, L110303, L110306
—
Z-1268-2020
Pentax Video Colonoscope Model: EC38-i10L; Serial Numbers:L110746
1 unit
Based on the official FDA remedy
What to do — step by step
Contact Manufacturer
Reach out to Pentax of America Inc for specific instructions on handling affected units.
Where it went and when
Where it was distributed
Distributed in Massachusetts and North Carolina.
Listed by the agency
Not listed
FDA distribution: “NC, MA” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Massachusetts, North Carolina.
Recall timeline
FDA terminated this recall 13 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
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-1268-2020 (January 3, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1268-2020 to see it in context.
Plain-language summary written by qwen3:4b on September 23, 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.