FDA Recall Database: Class II Recall: OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112 by Olympus Corporation of the Americas

Key facts

What this classification means

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is Olympus Corporation of the Americas and the affected product is described in FDA's record as: OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112. FDA's stated reason for the recall is: Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.. The recall is tracked under FDA recall number Z-1900-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do. Recall status can change while FDA and the recalling firm continue corrective actions, so checking the firm's own notice for the most current guidance is recommended. Adverse events believed to be related to a recalled product can be reported to FDA's MedWatch program, which FDA uses to monitor safety signals after a recall is opened.

What consumers should do

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with FDA -- OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112 -- and the recall number Z-1900-2026. If it matches, stop using or distributing it and contact Olympus Corporation of the Americas or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.

Olympus Corporation of the Americas’s FDA history

Argus HQ has recorded 16 total FDA actions tied to Olympus Corporation of the Americas: 0 warning letters, 16 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

How serious is this recall?

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote.

What should someone who has this product do?

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Check the product against FDA's description (OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112) and recall number Z-1900-2026, then follow Olympus Corporation of the Americas's recall instructions.

Has Olympus Corporation of the Americas had other FDA recalls or enforcement actions?

Yes. Argus HQ has recorded 16 total FDA actions tied to Olympus Corporation of the Americas, including 16 recalls and 0 warning letters.

What is the FDA recall number for this event?

FDA recall number Z-1900-2026.

Related enforcement actions