RecallRadar

FDA Device recall Z-1907-2026

OER-ELITE Endoscope Reprocessor Connecting Tubes

On 2026-04-29 the FDA classified a Class II recall of OER-ELITE Endoscope Reprocessor Connecting Tubes by Olympus, citing potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1907-2026
ClassificationClass II
Statusongoing
Initiated2026-03-25
Published2026-04-29
Last updated2026-09-13 11:58 UTC
CompanyOlympus
DistributionUS

Product

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2119.

Reason

Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

Identifiers

code_info
Model Number: MAJ-2119. UDI Number: 04953170404146. Lot Numbers: 09A, 0XA, 0YA, 0ZA, 11A, 14A,15A, 16A, 17A, 18A,1XA, 1…Model Number: MAJ-2119. UDI Number: 04953170404146. Lot Numbers: 09A, 0XA, 0YA, 0ZA, 11A, 14A,15A, 16A, 17A, 18A,1XA, 1YA, 1ZA, 22A, 23A, 24A, 25A, 26A, 27A, 28A, 29A, 2XA, 2YA, 2ZA, 31A, 32A, 33A, 34A, 35A, 36A, 37A, 38A, 3XA, 3YA, 3ZA, 41A, 42A, 43A, 44A, 45A, 46A, 47A, 48A, 4XA, 4YA, 51A.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1907-2026%22

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