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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 98544

12 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 25, 2026
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Olympus Corporation of the Americas

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

12 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 12

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2110. May be included with the Olympus OER-ELITE.

Z-1898-2026
Recall number
Z-1898-2026
Initiated
March 25, 2026
Classification
Class II
Status
Ongoing
Quantity
9,757 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Model Number: MAJ-2110. UDI Number: 04953170404054. Lot Numbers: 09A, 0XA, 0YA, 0ZA, 11A, 12A, 22A, 23A, 24A, 25A, 26A, 27A, 28A, 29A, 2XA, 2YA, 2ZA, 31A, 32A, 33A, 34A, 35A, 36A, 37A, 38A, 39A, 3XA, 3YA, 3ZA, 41A, 42A, 43A, 44A, 45A, 46A, 47A, 48A, 49A, 4XA, 4YA, 4ZA, 51A.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, China, Hong Kong, Japan, South Korea and Taiwan.

device · product 2 of 12

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2111

Z-1899-2026
Recall number
Z-1899-2026
Initiated
March 25, 2026
Classification
Class II
Status
Ongoing
Quantity
10,141 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Model Number: MAJ-2111. UDI Number: 04953170404061. Lot Numbers: 09A, 0XA, 0YA, 0ZA, 11A, 12A, 22A, 24A, 25A, 26A, 27A, 28A, 29A, 2XA, 2YA, 2ZA, 31A, 32A, 33A, 34A, 35A, 36A, 37A, 38A, 39A, 3XA, 3YA, 3ZA, 41A, 42A, 43A, 44A, 45A, 46A, 47A, 48A, 49A, 4XA, 4YA, 4ZA, 51A.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, China, Hong Kong, Japan, South Korea and Taiwan.

device · product 3 of 12

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112

Z-1900-2026
Recall number
Z-1900-2026
Initiated
March 25, 2026
Classification
Class II
Status
Ongoing
Quantity
8,994 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Model Number: MAJ-2112. UDI Number: 04953170404078. Lot Numbers: 09A, 0XA, 0YA, 0ZA, 11A, 12A, 21A, 22A, 23A, 24A, 25A, 26A, 27A, 28A, 29A, 2XA, 2YA, 2ZA, 31A, 32A, 33A, 34A, 35A, 36A, 37A, 38A, 39A, 3XA, 3YA, 3ZA, 41A, 42A, 43A, 44A, 45A, 46A, 47A, 48A, 49A, 4XA, 4YA, 4ZA, 51A.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, China, Hong Kong, Japan, South Korea and Taiwan.

device · product 4 of 12

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2113.

Z-1901-2026
Recall number
Z-1901-2026
Initiated
March 25, 2026
Classification
Class II
Status
Ongoing
Quantity
8,936 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Model Number: MAJ-2113. UDI Number: 04953170404085. Lot Numbers: 09A, 0XA, 0YA, 0ZA, 11A, 12A, 22A, 24A, 25A, 26A, 27A, 28A, 29A, 2XA, 2YA, 2ZA, 31A, 32A, 33A, 34A, 35A, 36A, 37A, 38A, 39A, 3XA, 3YA, 3ZA, 41A, 42A, 43A, 44A, 45A, 46A, 47A, 48A, 49A, 4XA, 4YA, 4ZA, 51A.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, China, Hong Kong, Japan, South Korea and Taiwan.

device · product 5 of 12

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2114.

Z-1902-2026
Recall number
Z-1902-2026
Initiated
March 25, 2026
Classification
Class II
Status
Ongoing
Quantity
2,143 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Model Number: MAJ-2114. UDI Number: 04953170404092. Lot Numbers: 09A, 0XA, 0YA, 0ZA, 11A, 12A, 24A, 25A, 26A, 27A, 28A, 29A, 2XA, 2YA, 2ZA, 31A, 32A, 33A, 34A, 35A, 36A, 37A, 38A, 39A, 3XA, 3YA, 3ZA, 41A, 42A, 43A, 44A, 45A, 46A, 47A, 48A, 49A, 4XA, 4YA, 4ZA, 51A.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, China, Hong Kong, Japan, South Korea and Taiwan.

device · product 6 of 12

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2115.

Z-1903-2026
Recall number
Z-1903-2026
Initiated
March 25, 2026
Classification
Class II
Status
Ongoing
Quantity
2,089 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
XXX

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

Model Number: MAJ-2115. UDI Number: 04953170404108. Lot Numbers: 09A, 0XA, 0YA, 0ZA, 11A, 12A, 25A, 26A, 27A, 28A, 29A, 2XA, 2YA, 2ZA, 31A, 32A, 33A, 34A, 35A, 36A, 37A, 38A, 39A, 3XA, 3YA, 3ZA, 41A, 42A, 43A, 44A, 45A, 46A, 47A, 48A, 49A, 4XA, 4YA, 51A.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, China, Hong Kong, Japan, South Korea and Taiwan.

device · product 7 of 12

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116.

Z-1904-2026
Recall number
Z-1904-2026
Initiated
March 25, 2026
Classification
Class II
Status
Ongoing
Quantity
373 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Model: MAJ-2116. UDI Number: 04953170404115. Lot Numbers: 09A, 0XA, 0YA, 0ZA, 11A, 25A, 26A, 27A, 28A, 45A, 46A, 47A, 48A, 49A, 4XA, 4YA, 51A.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, China, Hong Kong, Japan, South Korea and Taiwan.

device · product 8 of 12

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2117.

Z-1905-2026
Recall number
Z-1905-2026
Initiated
March 25, 2026
Classification
Class II
Status
Ongoing
Quantity
1,929 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Model Number: MAJ-2117. UDI Number: 04953170404122. Lot Numbers: 09A, 0XA, 0YA, 0ZA, 11A, 12A, 24A, 25A, 26A, 27A, 28A, 29A, 2XA, 2YA, 2ZA, 31A, 32A, 33A, 34A, 35A, 36A, 37A, 39A, 3XA, 3YA, 3ZA, 41A, 42A, 43A, 44A, 45A, 46A, 47A, 48A, 49A, 4YA, 4ZA, 51A.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, China, Hong Kong, Japan, South Korea and Taiwan.

device · product 9 of 12

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2118.

Z-1906-2026
Recall number
Z-1906-2026
Initiated
March 25, 2026
Classification
Class II
Status
Ongoing
Quantity
1,259 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Model Number: MAJ-2118. UDI Number: 04953170404139. Lot Numbers: 09A, 0XA, 0YA, 0ZA, 11A, 12A, 23A, 24A, 25A, 26A, 27A, 28A, 2YA, 34A, 35A, 36A, 37A, 38A, 3XA, 3YA, 3ZA, 41A, 42A, 43A, 44A, 45A, 46A, 47A, 48A, 49A, 4XA, 4YA, 4ZA, 51A.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, China, Hong Kong, Japan, South Korea and Taiwan.

device · product 10 of 12

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

Z-1907-2026
Recall number
Z-1907-2026
Initiated
March 25, 2026
Classification
Class II
Status
Ongoing
Quantity
741 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, China, Hong Kong, Japan, South Korea and Taiwan.

device · product 11 of 12

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2138.

Z-1908-2026
Recall number
Z-1908-2026
Initiated
March 25, 2026
Classification
Class II
Status
Ongoing
Quantity
808 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Model Number: MAJ-2138. UDI Number: 04953170404184. Lot Numbers: 09A, 0XA, 0YA, 0ZA, 11A, 12A, 24A, 25A, 26A, 27A, 28A, 29A, 2XA, 2YA, 3XA, 3YA, 3ZA, 41A, 42A, 43A, 44A, 45A, 46A, 47A, 48A, 49A, 4XA, 4YA, 4ZA, 51A.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, China, Hong Kong, Japan, South Korea and Taiwan.

device · product 12 of 12

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2330.

Z-1909-2026
Recall number
Z-1909-2026
Initiated
March 25, 2026
Classification
Class II
Status
Ongoing
Quantity
1,829 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Model Number: MAJ-2330. UDI Number: 04953170404207. Lot Numbers: 09A, 0XA, 0YA, 0ZA, 11A, 12A, 24A, 25A, 26A, 27A, 28A, 29A, 2XA, 2YA, 2ZA, 31A, 32A, 33A, 34A, 35A, 36A, 38A, 39A, 3XA, 3YA, 3ZA, 41A, 42A, 43A, 44A, 45A, 46A, 47A, 48A, 49A, 4XA, 4YA, 4ZA, 51A.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, China, Hong Kong, Japan, South Korea and Taiwan.

Field note

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