Olympus Corporation of the Americas recalls Veran : Endobronchial Always on Track Models: INS-0392 AOTT 21ga Needle, 12mm L, 1.8mm OD, 5/BX INS-0382 AOTT 19ga Needle,…
Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requirements and…
Read the official notice →- Date
- 2023-10-11
- Country
- United States
- Brand
- Olympus Corporation of the Americas
- Product
- Veran : Endobronchial Always on Track Models: INS-0392 AOTT 21ga Needle, 12mm L, 1.8mm OD, 5/BX INS-0382 AOTT 19ga Needle, 12mm L, 1.8 OD,…
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide and the countries of CN, DE, HK, IT,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2023-11-15
USOlympus Corporation of the Americas recalls EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-P190
There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close to the distal end of the…
- 2023-10-25
- US
Olympus Corporation of the Americas recalls Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery.
There have been reports of patients suffering arrhythmias, reported as short cardiac arrests, during surgical procedures where UHI-4s were used. These events may have been due to an over insufflation of the abdominal…
- 2023-10-18
- US
Olympus Corporation of the Americas recalls THUNDERBEAT, 5MM, 35CM, Front-actuated Grip Type S. Model: TB-0535FCS Indicated for open, laparoscopic (including…
Thunderbeats blue seal button may remain in the engaged position after the button is released and not immediately return to a neutral position may result in prolonged surgery
- 2023-09-06
- US
Olympus Corporation of the Americas recalls Olympus Bronchovideoscope, Models BF-3C40 & BF-N20.
Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
- US
Olympus Corporation of the Americas recalls Visera Hysterovideoscope Olympus HYF Type V
IFU labeling is being updated to revise EtO gas mixture and elimination of reusable cleaning brushes.
FDA · DeviceOlympus Corporation of the AmericasUS Nationwide distribution including in the states of AL, AZ, CA, CO, CT, FL,…Official notice → - US
Olympus Corporation of the Americas recalls EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V
Recent reports of patient infection.
Other drugs & medical recalls in the United States
- 2023-10-18
- US
Scynexis, Inc. recalls BREXAFEMME (Ibrexafungerp) tablets 150 mg, 4 count cartons, Rx Only, Manufactured for and distributed by SCYNEXIS, Inc., Jersey City, NJ…
Cross Contamination with Other Products: Potential cross-contamination of ibrexafungerp citrate drug substance with ezetimibe (a non-antibacterial beta-lactam compound).
- 2023-10-11
- US
Siemens Healthcare Diagnostics, Inc. recalls ADVIA Chemistry Iron_2 (IRON_2) Reagents, Material Numbers 10377510 (6 x 350 tests) and 10341118 (7 x 145 tests)
There is a potential for a positive bias on Quality Control (QC) and patient sample results when using some IRON_2 reagent wedge pairs. When the issue occurs, the observed bias will vary wedge to wedge.
- US
Qiagen GmbH recalls therascreen ¿KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used on the Rotor-Gene Q MDx instrument for the detection of seven somatic…
Handbook Revision (Rev13) a dilution step is indicated as an Action when having the Flag SAMPLE_INT_CTRL_FAIL. A dilution of CRC tissue could lead to a false negative result. To remove ambiguity, an alteration must be…
FDA · DeviceQiagen GmbHWorldwide - US Nationwide distribution in the states of AZ, CA, FL, IL, IN,…Official notice → - US
Thoratec Corp. recalls Heartmate 3 LVAS Implant Kit, REF: 106524US, 106524INT; Heartmate XVE & HeartMate II Apical Coring Knife, REF: 1050
Inability to start and/or complete the coring procedure due to inadequate sharpness of the Apical Coring Knife, provided with Left Ventricular Assist System, could result in an extended procedure or surgical time while…
FDA · DeviceThoratec Corp.Worldwide - US Nationwide distribution including in the states of AL, AR, AZ,…Official notice → - US
Medtronic Neuromodulation recalls Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators.
The original version of the A71100 Restore Clinician Programmer Application has been identified to have a compatibility issue with some legacy clinician programmer software resulting in the programmer having an…
FDA · DeviceMedtronic NeuromodulationWorldwide distribution - US Nationwide (there was government and military…Official notice → - US
GE Medical Systems China Co., Ltd. recalls F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms)
There is a potential interruption of data communication between E-modules inserted in the F2-01 Frame and CARESCAPE ONE and CARESCAPE Canvas 1000 patient monitors if the F2-01 Frame has not been powered down within the…
FDA · DeviceGE Medical Systems China Co., Ltd.Worldwide distribution - US Nationwide and the countries of Australia,…Official notice →