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U.S. Department of Health and Human Services

Class 2 Device Recall Olympus Single Use Electrosurgical Snare SD400

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 Class 2 Device Recall Olympus Single Use Electrosurgical Snare SD400see related information
Date Initiated by FirmOctober 06, 2025
Date PostedNovember 07, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0482-2026
Recall Event ID 97733
510(K)NumberK172734 
Product Classification Snare, flexible - Product Code FDI
ProductBrand Name: Olympus Single Use Electrosurgical Snare SD-400 Product Name: Single Use Electrosurgical Snare Model/Catalog Number: SD-400U-10 Product Description: These instruments have been designed to be used with an Olympus endoscope for the removal and/or cauterization of diminutive polyps, sessile polyps, pedunculated polyps, and tissue from within the GI tract.
Code Information Model: SD-400U-10; Lot Numbers: 27V, 28V, 29V, 2XV, 2YV, 2ZV, 31V, 32V, 33V, 34V, 35V, 36V, 37V, 38V, 39V, 3XV, 3YV, 3ZV, 41V, 42V, 43V, 44V, 45V, 46V, 47V, 48V, 49V, 4XV, 4YV, 51V, 52V, 53V, 54V, 55V, 56V, 57V UDI: 04953170408243
FEI Number 2429304
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		Sterility compromised from small holes that may occur during packaging of the device pouches into the shelf carton and/or during transportation of the shelf carton.
FDA Determined
Cause 2		Packaging
ActionOn October 6, 2025 URGENT: MEDICAL DEVICE RECALL letters were sent to customers. Actions to be taken: Examine your inventory and quarantine any affected devices. Cease usage of the product immediately. Please contact customer service to request a return material authorization, a credit will be issued for any returned product. Please forward this notice to other users who may have the affected products if you have further distributed it. Olympus requests you to report any complaints, including holes in device packaging, to our Technical Assistance Center (TAC) at 1- 800-848-9024, option 1, and the FDA. Adverse events experienced with the use of this product may also be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. Olympus fully appreciates your prompt cooperation in addressing this situation. If you require additional information, please do not hesitate to contact me directly by phone at (647) 999-3203 or by e-mail Cynthia.Ow@Olympus.com.
Quantity in Commerce48208 units
DistributionWorldwide distribution - US Nationwide and the countries of GU, and MP.
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 = FDI
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