• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Water Filter MAJ2318

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Water Filter MAJ2318see related information
Date Initiated by FirmJanuary 16, 2024
Date PostedFebruary 07, 2024
Recall Status1 Open3, Classified
Recall NumberZ-1009-2024
Recall Event ID 93792
510(K)NumberK103264 
Product Classification Accessories, cleaning, for endoscope - Product Code FEB
ProductWater Filter MAJ-2318. This MAJ-2318 water filter has been designed to be used with Olympus endoscope reprocessor for prevent contamination of the rinse water. The MAJ-2318 water filter is compatible with OER-ELITE and OER-MINI.
Code Information UDI-DI 04953170401473 Lots 36A, 37A, 38A Affected product may have also been packaged within OER boxes (OER-Elite and OER-MINI)
Recalling Firm/
Manufacturer
Olympus Corporation of the Americas
3500 Corporate Pkwy
Center Valley PA 18034-8229
For Additional Information ContactCynthia Ow
484-896-5000
Manufacturer Reason
for Recall
Water filter may have been assembled incorrectly, resulting in unfiltered tap water being used for reprocessing. This may expose a patient to a potentially contaminated device, presenting a risk of infection or sepsis.
FDA Determined
Cause 2
Process control
ActionOn January 16, 2024, the firm notified customers of the issue via URGENT MEDICAL DEVICE FIELD CORRECTIVE ACTION letters. Customers were instructed to immediately assess all MAJ-2318 at their facility to check the model and lot number. Customers were given detailed instructions on how to identify affected product, including for MAJ-2318 installed in the OER machine. Please contact your Olympus customer service representative at 1-800-848-9024, option 2 to obtain a Return Material Authorization to return any affected product. Customers who have further distributed product should notify downstream accounts at once. If you require assistance with identifying affected product, please contact the Olympus Technical Assistance Center at 1- 800-848-9024, option 1. If you have questions about this recall, please contact the recalling firm at (647) 999-3203 or by e-mail at Cynthia.Ow@Olympus.com.
Quantity in Commerce877 MAJ-2318, 119 OER-Elite, 3 OER-MINI
DistributionDomestic US distribution nationwide.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = FEB
-
-