Z-0482-2026Class II

Brand Name: Olympus Single Use Electrosurgical Snare SD-400 Product Name: Single Use Electrosurgical Snare...

Name: Z-0482-2026 Brand Name: Olympus Single Use Electrosurgical Snare SD-400 Product Name: Single Use Electrosurgical Snare...
Creator: Olympus Corporation of the Americas
Published: 2025-10-06
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2025-10-06 / Open, Classified / root cause: packaging

FDA source

Olympus Corporation of the Americas began a recall of Brand Name: Olympus Single Use Electrosurgical Snare SD-400 Product Name: Single Use Electrosurgical Snare Model/Catalog Number: SD-400U-10 Product... on 2025-10-06. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0482-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-10-06
Posted: 2025-11-07
Recalling firm: OLYMPUS Corporation of the Americas
Product: Brand 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.
Product code: FDI Snare, Flexible
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.
Root cause tag: packaging
FDA root cause: Packaging
Action: On 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 [email protected].
Quantity in commerce: 48208 units
Distribution: Worldwide distribution - US Nationwide and the countries of GU, and MP.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0482-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0482-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-19	2025-11-07
Z-0483-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-19	2025-11-07

Product code FDI

K172734Class IISingle Use Electrosurgical Snare SD-400Olympus Medical Systems Corp. / cleared 2017-12-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)