Pentax of America Inc Pentax Video Colonoscope Model: EC34-i10L Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Pentax Video Colonoscope Model: EC34-i10L
Brand
Pentax of America Inc
Lot Codes / Batch Numbers
Serial Numbers: L110300, L110301, L110303, L110306
Products Sold
Serial Numbers: L110300, L110301, L110303, L110306
Pentax of America Inc is recalling Pentax Video Colonoscope Model: EC34-i10L due to Distributed in the USA without an approved 510K. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Distributed in the USA without an approved 510K
Recommended Action
Per FDA guidance
Pentax Medical contacted US Affected Customers by telephone to inform them of the pending action and to advise they quarantine the affected products Pentax issued URGENT MEDICAL DEVICE CORRECTIONAND REMOVAL Letter via UPS dated 1/3/20 states: reason for recall, health risk and action to take: Please quarantine the units your facility owns, complete the response form, and return it to PENTAX Medical using the e-mail address or fax number listed below. Upon return of the response form, PENTAX will contact your facility to arrange the return of the affected units. Loaner units will be supplied until this issue is resolved. Question contact: 1-800-431-5880 (8:30 AM 5:00 PM, Monday Friday, EST) Fax: 201-799-4063 (alternate 201-391-4189) Email: customeradvisories@pentaxmedical.com
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
MA, NC
Page updated: Jan 10, 2026