Olympus Corporation of the Americas recalls Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These instruments…
Devices which did not undergo thermoforming could deform and lose performance.
Read the official notice →- Date
- 2026-02-11
- Country
- United States
- Brand
- Olympus Corporation of the Americas
- Product
- Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These instruments have been…
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution including in the states of AL, AR, AZ,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Olympus Corporation of the Americas recalls
- 2026-03-04
USOlympus Corporation of the Americas recalls Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;
Product being removed due to incompatibility when used in conjunction with a GreenLight Laser for BPH therapy which could damage the tip of the device.
- 2026-02-25
- US
Olympus Corporation of the Americas recalls Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S
Firm is initiating a removal due to continued reports of adverse events.
FDA · DeviceOlympus Corporation of the AmericasWorldwide distribution - US Nationwide and the countries of Brazil, Canada,…Official notice → - US
Olympus Corporation of the Americas recalls Olympus High Flow Insufflation Unit. Model Number: UHI-3. Used for insufflation of the abdominal cavity, and automatic…
Issue with software algorithm which may lead to overpressure events.
- 2026-02-11
- US
Olympus Corporation of the Americas recalls Brand Name: Single Use Electrosurgical Knife Product Name: Olympus Single Use Electrosurgical Knife KD-640L Model/Catalog…
A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.
- 2025-12-03
- US
Olympus Corporation of the Americas recalls Brand Name: EVIS EXERA III Duodenovideoscope Product Name: Olympus TJF-Q190V Model/Catalog Number: TJF-Q190V Product…
Continued reports of positive cultures and infections have identified updates to the reprocessing materials to minimize potential deviations in TJF duodenoscope reprocessing. Olympus is informing users of these…
- US
Olympus Corporation of the Americas recalls Brand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Model/Catalog Number: HX-400U-30 Used with an…
Potential that the ligation loop was unable to release or detach as expected during use, causing the loop to become unintentionally fixed around patient anatomy.
Other drugs & medical recalls in the United States
- 2026-02-11
- US
Maquet Cardiopulmonary Gmbh recalls Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720;
Internal investigations have identified an issue with the durability of the connecting cable near the connection to the Venous Bubble Sensor. Excessive bending of the connecting cable can lead to full damage of the…
FDA · DeviceMaquet Cardiopulmonary GmbhWorldwide Distribution: US (Nationwide) and OUS (International) to countries…Official notice → - US
FUJIFILM Healthcare Americas Corporation recalls FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)
It was found that the contacts of the electromagnetic contactors used inside the cabinet of the X-ray high-voltage generator were welded, and the current might continue to be supplied to the power supply circuit even…
FDA · DeviceFUJIFILM Healthcare Americas CorporationUS Nationwide distribution in the states of AK, CA, CT, FL, IL, NH, OH, WI.Official notice → - US
Wilson-Cook Medical Inc. recalls Product Name: Nasal Jejunal Feeding Tube REF: NJFT-10
Nasal feeding tube packaged without the nasal transfer tube component.
FDA · DeviceWilson-Cook Medical Inc.International distribution to the country of Australia.Official notice → - US
Changchun Wancheng Bio-Electron Co., Ltd. recalls Male Fertility Sperm Test for Home Use (Cassette)
Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by…
FDA · DeviceChangchun Wancheng Bio-Electron Co., Ltd.US Nationwide distribution in the states of TX, GA, CA.Official notice → - US
Vortex Surgical Inc. recalls Vortex Surgical TID Pharos Illuminated Depressor, VS0801B
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FDA · DeviceVortex Surgical Inc.Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, CT, FL,…Official notice → - US
Vortex Surgical Inc. recalls Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.25GA Convenience Kit - XES…
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
FDA · DeviceVortex Surgical Inc.Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, CT, FL,…Official notice →