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.
Read the official notice →- Date
- 2026-02-25
- Country
- United States
- Brand
- Olympus Corporation of the Americas
- Product
- Olympus High Flow Insufflation Unit. Model Number: UHI-3. Used for insufflation of the abdominal cavity, and automatic suction and smoke…
- Classification
- Class I
- Units
- Nationwide distribution
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urological applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
- US
Olympus 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 → - 2026-02-11
- US
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.
FDA · DeviceOlympus Corporation of the AmericasWorldwide - US Nationwide distribution including in the states of AL, AR, AZ,…Official notice → - 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…
Other drugs & medical recalls in the United States
- 2026-02-25
- US
Medline Industries, LP recalls Medline Industries IV Administration and Extension Sets: 1) DBD-IV ADMIN SET,60DRP,1NEEDLE-FREE VALV, Model Number: DYNDTB0529; 2) IV…
Under circumstances involving exposure to particular chemicals and mechanical forces, the male luer connectors for the specified IV Administration and Extension sets may leak, crack, and/or break during use, which may…
FDA · DeviceMedline Industries, LPWorldwide distribution - US Nationwide and the country of Bahamas.Official notice → - US
Integra LifeSciences Corp. (NeuroSciences) recalls MediHoney Gel with Active Leptospermum Honey. Model/Catalog Numbers: (1) 31805, (2) 31815. MediHoney Gel dressing…
Potential packaging failures, which could lead to a breach in the sterile barrier.
FDA · DeviceIntegra LifeSciences Corp. (NeuroSciences)Worldwide - US Nationwide distribution in the states of TX, MI, FL, IN, MO,…Official notice → - US
Wilson-Cook Medical Inc. recalls Teslatome Bipolar Sphincterotomes REF: TESLA-B2535-260 Model Number: G60784 UDI-DI code: 00827002607842 REF: TESLA-B2535-450 Model…
Due to product that may contain a void in the material that separates the wire guide and cutting wire lumens, which may cause an inappropriate path of current during cutting.
FDA · DeviceWilson-Cook Medical Inc.U.S. Distribution to states of: CA, CO, IN, and NC.Official notice → - 2026-02-18
- US
Steris Corporation recalls Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H
This is a sub-recall of event RES 96885. The supplier identified that during their manufacturing process for a limited batch of MNA-6x0 (adapter) components the incorrect configuration file was used.
FDA · DeviceSteris CorporationUS Nationwide distribution in the states of FL, NC, NY, OH, TN, TX, and VA.Official notice → - US
SUREPULSE MEDICAL LTD recalls Surepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate Monitor
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
FDA · DeviceSUREPULSE MEDICAL LTDWorldwide - US Nationwide distribution in the states of CT, TX and the…Official notice → - US
Intuitive Surgical, Inc. recalls da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45
Robotic-assisted surgical system has Viewer Display manufactured with outdated firmware, may result in loss of one display-loss of 3D surgical field (depth perception) but 2D maintained, or loss of both…
FDA · DeviceIntuitive Surgical, Inc.US Nationwide distribution in the states of KS, AZ, MA, FL, MI, NC, IL, DC,…Official notice →