is it on recall

Home / Brand archive

Olympus Corporation of the Americas recall records

323 reported ongoing

327 records in this archive. Latest source date Aug 18, 2026.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0720 Product Description: These instruments have been designed to be used with an Olympus endo...

Devices which did not undergo thermoforming could deform and lose performance.

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, GU, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM,...

Official source
FDA device enforcement

Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0730 Product Description: These instruments have been designed to be used with an Olympus endo...

Devices which did not undergo thermoforming could deform and lose performance.

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, GU, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM,...

Official source
FDA device enforcement

Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These instruments have been designed to be used with an Olympus endo...

Devices which did not undergo thermoforming could deform and lose performance.

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, GU, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM,...

Official source
FDA device enforcement

Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0720 Product Description: These instruments have been designed to be used with an Olympus endo...

Devices which did not undergo thermoforming could deform and lose performance.

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, GU, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM,...

Official source
FDA device enforcement

Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0730 Product Description: These instruments have been designed to be used with an Olympus endo...

Devices which did not undergo thermoforming could deform and lose performance.

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, GU, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM,...

Official source
FDA device enforcement

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These instruments have been designed to be used with an Olympus endosc...

Devices which did not undergo thermoforming could deform and lose performance.

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, GU, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM,...

Official source
FDA device enforcement

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1530 Product Description: These instruments have been designed to be used with an Olympus endosc...

Devices which did not undergo thermoforming could deform and lose performance.

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, GU, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM,...

Official source
FDA device enforcement

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3030 Product Description: These instruments have been designed to be used with an Olympus endosc...

Devices which did not undergo thermoforming could deform and lose performance.

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, GU, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM,...

Official source
FDA device enforcement

Brand Name: Disposable Triple Lumen Sphincterotome Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0320 Product Description: These instruments...

Devices which did not undergo thermoforming could deform and lose performance.

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, GU, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM,...

Official source
FDA device enforcement

Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0725 Product Description: These instruments have been designed to be used with an Olympus endo...

Devices which did not undergo thermoforming could deform and lose performance.

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, GU, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM,...

Official source
FDA device enforcement

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3020 Product Description: These instruments have been designed to be used with an Olympus endosc...

Devices which did not undergo thermoforming could deform and lose performance.

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, GU, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM,...

Official source
FDA device enforcement

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3025 Product Description: These instruments have been designed to be used with an Olympus endosc...

Devices which did not undergo thermoforming could deform and lose performance.

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, GU, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM,...

Official source
FDA device enforcement

Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0725; Software Version: N/A Product Description: These instruments have be...

Devices which did not undergo thermoforming could deform and lose performance.

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, GU, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM,...

Official source
FDA device enforcement

Brand Name: ShockPulse-SE Lithotripsy System SPL-SR Product Name: ShockPulse-SE Lithotripsy System - Reusable Probes Model/Catalog Number: SPL-SR Product Description: The ShockP...

Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator receptacle may cause these issues.

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Bolivia, Chile, India, China, EU, Singapore, Australia, Korea, and Japan.

Official source
FDA device enforcement

Brand Name: ShockPulse-SE Lithotripsy System SPL-S Product Name: ShockPulse-SE Lithotripsy System - Single Use Probes Model/Catalog Number: SPL-S Product Description: The ShockP...

Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator receptacle may cause these issues.

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Bolivia, Chile, India, China, EU, Singapore, Australia, Korea, and Japan.

Official source
FDA device enforcement

Brand Name: ShockPulse-SE Lithotripsy System Product Name: ShockPulse-SE Lithotripsy System - Generator Model/Catalog Number: SPL-G Product Description: The ShockPulse Lithotrip...

Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator receptacle may cause these issues.

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Bolivia, Chile, India, China, EU, Singapore, Australia, Korea, and Japan.

Official source

Reasons in these listed records

  • Devices which did not undergo thermoforming could deform and lose performance.
  • Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator receptacle may cause these issues.
  • Complaints of the ceramic tip of the resection sheath breaking have been received.

These examples come from this result page and are not a ranking of every recall reason.

Checking Olympus Corporation of the Americas

Is there a recall on olympus corporation of the americas right now?

This archive contains 327 records, including 323 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

Keep checking

Search Olympus Corporation of the AmericasBrowse related productsReview source dates