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U.S. Department of Health and Human Services

Class 2 Device Recall Blue Silicone

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 Class 2 Device Recall Blue Siliconesee related information
Date Initiated by FirmJune 18, 2025
Date PostedJuly 21, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2139-2025
Recall Event ID 96982
510(K)NumberK890328 
Product Classification Hysteroscope (and accessories) - Product Code HIH
ProductBlue Silicone, Reusable Silicone Seal 6 - 12 FR. Model Number: CS-B612. The reusable silicone seals fit over the biopsy port of endoscopes to seal off the working channel. Some contain a lumen which allows instruments to be passed through the seal and minimize or prevent fluid leakage during endoscopic procedures.
Code Information Model Number: CS-B612. UDI-DI: 00821925038318, 00821925001176. All lot numbers
Recalling Firm/
Manufacturer		 Olympus Corporation of the Americas
3500 Corporate Pkwy
Center Valley PA 18034-8229
For Additional Information ContactCynthia Ow
647-9993203
Manufacturer Reason
for Recall		Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
FDA Determined
Cause 2		Packaging change control
ActionOlympus notified consignees on about 06/18/2025 via letter. Consignees were instructed to review the notification and arrange for the return of all affected units on hand, ensure all affected personnel are aware, and notify customers if the affected units were further distributed. Olympus also requested that consignees complete and return the response form acknowledging receipt of the notification.
Quantity in Commerce19 units
DistributionInternational distribution to the country of Japan.
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 = HIH
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