Olympus Corporation of the Americas recalls ASC PneumoLiner device, Part No. WA90500US (US market only) The Pneumoliner device is intended for use as a multiple…
Due to manufacturing error, the Pneumoliner Bag Distal Tab that exits the Introducer shaft is in the wrong orientation. This results in the user deploying the bag upside down, which will make tissue encapsulation and…
Read the official notice →- Date
- 2021-11-03
- Country
- United States
- Brand
- Olympus Corporation of the Americas
- Product
- ASC PneumoLiner device, Part No. WA90500US (US market only) The Pneumoliner device is intended for use as a multiple instrument port and…
- Classification
- Class II
- Units
- US Nationwide distribution to states of: AL, CA, CT, FL, IL, MD, MI, MN, MO,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2022-05-18
USOlympus Corporation of the Americas recalls BF-3C160: EVIS EXERA Bronchovideoscope
Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after high-level disinfection, and a recommendation on using…
- 2022-05-11
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Olympus Corporation of the Americas recalls Ultrasonic Gastrovideoscope, GF-UC140P-AL5. Intended for endoscopic real-time ultrasound imaging.
GF-UC140P-AL5 is no longer a compatible endoscope for reprocessing in the OER-Pro and presents an infection control risk to patients
- 2022-02-23
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Olympus Corporation of the Americas recalls OER-Elite Endoscope Reprocessor-for use in cleaning and high-level disinfection of heat sensitive Olympus flexible…
The detergent and alcohol tank tubing may have been incorrectly assembled in the OER-Elite. If the tubing is incorrectly assembled, alcohol will be dispensed instead of detergent for the cleaning cycle and detergent…
- 2022-02-09
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Olympus Corporation of the Americas recalls Spiration Valve System (SVS) Valve in Cartridge -A one-way endobronchial valves indicated for adult patients with shortness…
Mislabeled Patient Charge Label indicating model number SVS-V7-00 (7mm) instead of SVS-V9-00 (9mm)
FDA · DeviceOlympus Corporation of the AmericasUS Nationwide distribution in the states of AZ, CA, MA, NJ, PA, SC, TX, WI.Official notice → - 2021-12-22
- US
Olympus Corporation of the Americas recalls EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V Model Number: TJF-Q180V
Use of a TJF-Q180V with adhesive deterioration or other damages may pose a risk of endoscope contamination due to ineffective reprocessing or fluid invasion; contaminated endoscope can present an infection risk to…
- 2021-10-06
- US
Olympus Corporation of the Americas recalls BF-XP60 OES Bronchofiberscope, Model No. BF-XP60
The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
FDA · DeviceOlympus Corporation of the AmericasDomestic distribution nationwide. Product also distributed globally.Official notice →
Other drugs & medical recalls in the United States
- 2021-11-03
- US
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11097543
The firm has confirmed the potential for Atellica CH Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Hemoglobin A1c (A1c_E and A1c_EM) results. Falsely depressed Enzymatic Hemoglobin A1c…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide distribution.Official notice → - US
Becton Dickinson & Company recalls BD Syringe Tip Cap Bulk Sterile Convenience Pak-1000 units/shelf carton. Used to seal syringes and maintain container closure…
Holes in product packaging impacts package integrity and may compromise sterility.
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Smiths Medical ASD Inc. recalls Bivona Aire-Cuf Endotracheal Tube
Inadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of 325mm.
FDA · DeviceSmiths Medical ASD Inc.Worldwide distribution - US Nationwide distribution in the states of AL, AZ,…Official notice → - US
AB SCIEX recalls Cliquid MD version 3.4 software used in conjunction with Analyst MD software on SCIEX Citrine & 4500MD series liquid chromatography-tandem…
The values of the Internal Standard (IS) concentrations are incorrectly derived when the user builds a customized test, then set the IS column to hidden and left the column empty. This may lead to the user making…
FDA · DeviceAB SCIEXWorldwide distribution - US Nationwide distribution in the states of District…Official notice → - US
Xstrahl Limited recalls Concerto User Interface Software provided with the following systems: (1) Xstrahl 100 Electronic Brachytherapy - 100kV Superficial X-Ray…
If a saved treatment plan with 2 opposing beams is edited prior to approval, then Beam 2 is not updated with the changed parameters upon selecting save, resulting in error messages during the treatment and possible…
FDA · DeviceXstrahl LimitedWorldwide distribution - US Nationwide distribution in the states of AZ, CA,…Official notice → - US
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls C315-HIS Delivery Catheter
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