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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Olympus OER-ELITE Endoscope Reprocessor Connecting Tubes Recalled

Agency Publication Date: April 22, 2026
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Summary

Olympus Corporation of the Americas has recalled 48,999 connecting tubes used with the OER-ELITE Endoscope Reprocessor. The connecting tubes are used to facilitate the cleaning and disinfection of medical endoscopes. The recall was initiated because the lock levers on the Version 2 tubes may fail prematurely, which could interfere with the proper reprocessing of medical devices. No incidents or injuries have been reported to date.

Risk

If the tube lock levers fail, the reprocessor may not be able to effectively clean and disinfect endoscopes between patient uses. This creates a risk of cross-contamination or infection for patients undergoing endoscopic procedures.

What You Should Do

  1. Identify if you have the recalled OER-ELITE Endoscope Reprocessor Connecting Tubes by checking the model and lot numbers on your device packaging or the device label itself.
  2. Check your inventory for Model Numbers MAJ-2110, MAJ-2111, MAJ-2112, MAJ-2113, MAJ-2114, MAJ-2115, MAJ-2116, MAJ-2117, MAJ-2118, MAJ-2119, MAJ-2138, or MAJ-2330. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for additional information.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: OER-ELITE Endoscope Reprocessor Connecting Tubes (MAJ-2110)
Model / REF:
MAJ-2110
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
UDI:
04953170404054

May be included with the Olympus OER-ELITE.

Product: OER-ELITE Endoscope Reprocessor Connecting Tubes (MAJ-2111)
Model / REF:
MAJ-2111
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
UDI:
04953170404061
Product: OER-ELITE Endoscope Reprocessor Connecting Tubes (MAJ-2112)
Model / REF:
MAJ-2112
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
UDI:
04953170404078
Product: OER-ELITE Endoscope Reprocessor Connecting Tubes (MAJ-2113)
Model / REF:
MAJ-2113
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
UDI:
04953170404085
Product: OER-ELITE Endoscope Reprocessor Connecting Tubes (MAJ-2114)
Model / REF:
MAJ-2114
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
UDI:
04953170404092
Product: OER-ELITE Endoscope Reprocessor Connecting Tubes (MAJ-2115)
Model / REF:
MAJ-2115
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
UDI:
04953170404108
Product: OER-ELITE Endoscope Reprocessor Connecting Tubes (MAJ-2116)
Model / REF:
MAJ-2116
Lot Numbers:
09A
0XA
0YA
0ZA
11A
25A
26A
27A
28A
45A
46A
47A
48A
49A
4XA
4YA
51A
UDI:
04953170404115
Product: OER-ELITE Endoscope Reprocessor Connecting Tubes (MAJ-2117)
Model / REF:
MAJ-2117
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
UDI:
04953170404122
Product: OER-ELITE Endoscope Reprocessor Connecting Tubes (MAJ-2118)
Model / REF:
MAJ-2118
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
UDI:
04953170404139
Product: OER-ELITE Endoscope Reprocessor Connecting Tubes (MAJ-2119)
Model / REF:
MAJ-2119
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
UDI:
04953170404146
Product: OER-ELITE Endoscope Reprocessor Connecting Tubes (MAJ-2138)
Model / REF:
MAJ-2138
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
UDI:
04953170404184
Product: OER-ELITE Endoscope Reprocessor Connecting Tubes (MAJ-2330)
Model / REF:
MAJ-2330
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
UDI:
04953170404207

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98544
Status: Active
Manufacturer: Olympus Corporation of the Americas
Sold By: Authorized Medical Device Distributors; Olympus Direct Sales
Manufactured In: United States
Units Affected: 48,999
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.