Recall of Olympus Endoscope Reprocessor OER-Elite
Olympus Corporation of the Americas is recalling 2,929 units of the Endoscope Reprocessor OER-Elite due to compatibility issues with certain accessories.
Recall Article
What Happened
The recall is due to the MAJ-1443 and MAJ-1444 no longer being reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
Which Products Are Affected
The affected product is the Olympus Endoscope Reprocessor OER-Elite, with Model Number: N5789340. This includes 2,929 units, UDI-DI: 04953170404047, and Catalog number: N5789340. All Lot/Serial Numbers are affected, and the product was distributed nationwide in the United States.
What You Should Do
Consumers should contact Olympus Corporation of the Americas, as the recall was initiated via letter, for further instructions on returns or refunds.
Why This Matters
This recall involves medical devices that could affect healthcare procedures due to compatibility issues, potentially leading to temporary health consequences.
Source
Attribution: FDA. For more information, visit the FDA website and search for Recall Number Z-1612-2026 at https://www.fda.gov/.
Source: FDA Official Notice