Olympus Corporation of the Americas recalls Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,35 cm,…
The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Read the official notice →- Date
- 2025-01-29
- Country
- United States
- Brand
- Olympus Corporation of the Americas
- Product
- Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,35 cm, Front-actuated Grip Type…
- Classification
- Class II
- Units
- US Nationwide distribution and International: Algeria, Armenia, Australia,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2025-06-11
USOlympus Corporation of the Americas recalls Olympus EVIS EXERA III Duodenovideoscope. Model Number: TJF-Q190V
Recent post-market surveillance data suggests a possible association of higher microbial contamination levels from TJF duodenoscopes when manual cleaning was delayed beyond one hour and a presoak was performed,…
FDA · DeviceOlympus Corporation of the AmericasWorldwide Distribution: US (Nationwide) and OUS (International) countries to:…Official notice →- 2025-05-07
- US
Olympus Corporation of the Americas recalls Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Numbers:…
Preset treatment parameters are not consistently being used in accordance with the IFU.
FDA · DeviceOlympus Corporation of the AmericasWorldwide distribution - US Nationwide and the countries of AU, CA, SG, DE,…Official notice → - 2025-02-19
- US
Olympus Corporation of the Americas recalls Olympus Single Use Guide Sheath Kits with the following product descriptions and model numbers: 1. Single Use Guide Sheath…
Potential for the radiopaque tip of the guide sheath component to disassociate and fall off into the patient.
- 2025-01-22
- US
Olympus Corporation of the Americas recalls LithoCrushV Single Use Mechanical Lithotriptor V. Model Number: BML-V442QR-30. Single Use Mechanical Lithotriptor V used…
Potential for distal tip tearing of the Mechanical Lithotriptor V.
- US
Olympus Corporation of the Americas recalls Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number: MAJ-891. This instrument is designed to be…
Potential for inadvertent retention of biomaterial when the reprocessing procedure is not performed as instructed, so as not completely removing and disassembling the device.
- 2024-12-25
- US
Olympus Corporation of the Americas recalls Duravent Silicone Ventilation Tube. Model Number: 240075.
Potential that Duravent Silicone Ventilation Tubes may contain incorrect product, specifically, 1.32 mm Tiny T Tubes (model: 70240076) instead of the intended Duravent Silicone Ventilation Tubes.
FDA · DeviceOlympus Corporation of the AmericasAL, AZ, CA, IL, KY, MD, MN, MO, NC, ND, NY, OK, PA, SC, TN, TX, WA, WI.…Official notice →
Other drugs & medical recalls in the United States
- 2025-01-29
- US
Ortho-Clinical Diagnostics, INc. recalls Brand Name: VITROS Product Name: VITROS XT 7600 Integrated System Model/Catalog Number: 6844461 (New), 6272222 (Certified),…
The VITROS XT 7600 Integrated System software versions 3.8.0 may not correctly notify users if the Signal Reagent Pack exceeds the on-board and/or shelf-life expiration date. This could result in the use of expired…
FDA · DeviceOrtho-Clinical Diagnostics, INc.Worldwide distribution - US Nationwide and the countries of Australia,…Official notice → - US
Ortho-Clinical Diagnostics, INc. recalls Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: 6802413 (New), 6802415…
The VITROS 5600 Integrated System software versions 3.8.0 may not correctly notify users if the Signal Reagent Pack exceeds the on-board and/or shelf-life expiration date. This could result in the use of expired…
FDA · DeviceOrtho-Clinical Diagnostics, INc.Worldwide distribution - US Nationwide and the countries of Australia,…Official notice → - US
Becton Dickinson & Co. recalls BD PCR Cartridges used with MAX System. Model Number: 437519
Potential for signal drift in specific lots of BD PCR Cartridges.
FDA · DeviceBecton Dickinson & Co.Worldwide - US Nationwide distribution including in the states of AL, AR, AZ,…Official notice → - US
MICROVENTION INC. recalls Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx Only, Lot# 0000629846
Sterility assurance; microcatheter inner packaging may contain incomplete seal.
- US
St. Jude Medical recalls CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Hosptial Electronics System (PES) REF CM3000 Merlin.net Patient Care…
As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery (PA) pressure readings.
FDA · DeviceSt. Jude MedicalWorldwide - U.S. Nationwide distribution including in the states of AL, AR,…Official notice → - US
St. Jude Medical recalls Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Model MN6000) (Which interfaces with CardioMEMS" Hospital System…
Due to a data migration from on-premises server to the cloud environment, some customers reported that they were not able to transmit readings.
FDA · DeviceSt. Jude MedicalU.S.: CA, CT, GA, IL, MI, MN, NC, NJ, NY, OR, PA, TX, and WA. O.U.S.: N/AOfficial notice →