Olympus OER-ELITE Connecting Tube MAJ-2110 Class II Recall

Class 2 Device Recall Olympus Connecting Tube MAJ2110

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| | Class 2 Device Recall Olympus Connecting Tube MAJ2110 | |

May be included with the Olympus OER-ELITE. |
| 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. |
| FEI Number | 2429304 |
| Recalling Firm/
Manufacturer | Olympus Corporation of the Americas
3500 Corporate Pkwy
Center Valley PA 18034-8229 |
| For Additional Information Contact | Cynthia Ow
647-9993203 |
| Manufacturer Reason
for Recall | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. |
| FDA Determined
Cause | Device Design |
| Action | Olympus notified consignees on about 03/25/2026 via letter titled "URGENT: MEDICAL DEVICE REMOVAL." Consignees were notified of the issue and hazard involved and were instructed to examine inventory and OER-ELITE devices for the affected product. The current version has black lock levers. The previous versions have gray lock levers or integrated lock levers, which are the same color as the rest of the connector.

Consignees were instructed that if they have sufficient quantities of the current version (black) to support reprocessing needs, stop using the previous version and set aside for return. They may proceed with using the current version, only. If they have insufficient quantities of the current version (black) available, and do not have another method of endoscope reprocessing readily available, they may continue using the previous version(s) consistent with the Instructions for Use, which require users to inspect the connecting tube prior to use. Transition to the current version as soon as possible by placing an order through Customer Service at 1-800-848-9024, option 2. When sufficient quantities of the current version (black) are obtained to support reprocessing needs, stop using the previous version and only use the current version going forward. Then arrange for return the previous version of the connector.

Consignees were also requested to confirm receipt of the letter through the Olympus web portal and forward the notification to other users who may have the affected products if product were further distributed. |
| Quantity in Commerce | 9,757 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, China, Hong Kong, Japan, South Korea and Taiwan. |
| Total Product Life Cycle | TPLC Device Report |

| 1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes. | |

| 510(K) Database | 510(K)s with Product Code = FEB |