Drugs & medicalClass II

Olympus Corporation of the Americas recalls Berkeley VC-10 Vacuum Curettage System, Model No. VC-10. For transcervical aspiration of the uterine cavity.

Update to the Instruction for Use (IFU): Olympus is adding a new warning against the use of accessories which are not listed in the IFU. There have been reported adverse events involving the use of collection canisters…

Read the official notice →
Date
2022-10-19
Country
United States
Brand
Olympus Corporation of the Americas
Product
Berkeley VC-10 Vacuum Curettage System, Model No. VC-10. For transcervical aspiration of the uterine cavity.
Classification
Class II
Units
Domestic distribution nationwide. Foreign distribution to Canada and Japan.
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 Details may be shortened or out of date; the official notice is the authoritative source.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

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. 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

  1. 2023-02-22
  2. US
    Drugs & medicalClass II

    Olympus Corporation of the Americas recalls EVIS EXERA III Colonovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus,…

    A single CF-Q180AL colonovideoscope was utilized in a veterinary endoscopy procedure in advance of being assigned to a medical facility as a service loaner in error, potential for microbial contamination

    FDA · DeviceOlympus Corporation of the AmericasUS Nationwide distribution in the states of CA, FL, GA, NY, OR, VA.Official notice →
  3. 2023-02-15
  4. US
    Drugs & medicalClass II

    Olympus Corporation of the Americas recalls SPiN Thoracic Navigation System Model: SYS-4000 (SYS-4000D)

    A grainy image is observed when using a SPiN Vision Single-Use Flexible Bronchoscope (models INS-7100 or INS-7130) with the SYS-4000 system due to an incorrect DVI cable supplied may result in prolonged…

    FDA · DeviceOlympus Corporation of the AmericasFL, GA, IN, MD, MS, NY, OH, PA, RI, SC, VAOfficial notice →
  5. 2022-12-14
  6. US
    Drugs & medicalClass II

    Olympus Corporation of the Americas recalls HF Resection Electrodes, Model Numbers WA22602S, WA22603S, WA22621S and WA22657S

    An incompatible HF cable may be packaged with the HF Resection Electrodes. This cable cannot be connected to the electrosurgical generator and may lead to delay or cancellation of the surgical procedure.

    FDA · DeviceOlympus Corporation of the AmericasUS Nationwide domestic distribution.Official notice →
  7. 2022-10-05
  8. US
    Drugs & medicalClass II

    Olympus Corporation of the Americas recalls Olympus POWERSEAL 5MM, 37CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0537CJDA. An electrosurgical device…

    An out of specification component preventing the blue retention ring from keeping the rotation knob in place. This may result in a loose rotation collar and retention ring and cause delay of treatment

    FDA · DeviceOlympus Corporation of the AmericasNationwide OUS: AUSTRALIA, CANADA , HONG KONG, CHINA, KOREAOfficial notice →
  9. 2022-08-17
  10. US
    Drugs & medicalClass II

    Olympus Corporation of the Americas recalls ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S

    Mis-wired component-the improperly wired component can result in additional noise on the power supply output. Noise on the ultrasonic input circuit is not consistent with electromagnetic compatibility (EMC) standards…

    FDA · DeviceOlympus Corporation of the AmericasUS Nationwide distribution in the states of AL, NM.Official notice →
  11. 2022-07-06
  12. US
    Drugs & medicalClass II

    Olympus Corporation of the Americas recalls SOLTIVE SuperPulsed Laser Fibers, Model# Labeled TFL-FBX150BS (Carton) - 150 Micron Ball Tip Single Use Fiber Model #…

    Device model and size for affected lots of Laser Fibers may be mismatched between the product's carton, immediate pouch packaging, and/or the device.

    FDA · DeviceOlympus Corporation of the AmericasNationwide distribution in the US. Foreign distribution worldwide.Official notice →
All 114 Olympus Corporation of the Americas recalls →

Other drugs & medical recalls in the United States

  1. 2022-10-19
  2. US
    Drugs & medicalClass II

    Baxter Healthcare Corporation recalls Prismaflex HF20 Set (product code 109841). For use in providing continuous fluid management and renal replacement therapies.

    Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Extonian (Eesti) text. The mistranslation indicates contradictory information related to the patient body weight…

    FDA · DeviceBaxter Healthcare CorporationUS NationwideOfficial notice →
  3. US
    Drugs & medicalClass II

    LUMINOSTICS, INC dba CLIP HEALTH recalls Clip COVID Rapid Antigen Test Kit (25-pack), Catalog Number: MDL002

    COVID test kit shelf life was periodically extended, as real-time stability test timepoints passed, without FDA concurrence.

    FDA · DeviceLUMINOSTICS, INC dba CLIP HEALTHUS nationwide distributionOfficial notice →
  4. US
    Drugs & medicalClass II

    Steris Corporation recalls Hu-Friedy K360 Scalpel Handle, 360 Degree Scalpel Handle, REF K360

    The scalpel holder may separate from the handle for certain lots. If the tip falls off during use, it could fall into the patient's mouth which may result in a cut to the patient's mouth and also presents a choking…

    FDA · DeviceSteris CorporationDistribution to US states of IL, MA, NC, SC, and TN, Canada, China, Japan,…Official notice →
  5. US
    Drugs & medicalClass II

    American Contract Systems, Inc. recalls COVID Test Kit Nonsterile

    Kit incorrectly labeled for use with COVID testing and should not be used with any SARS-Co-V2 device.

    FDA · DeviceAmerican Contract Systems, Inc.Distribution to one customer in PA onlyOfficial notice →
  6. US
    Drugs & medicalClass II

    Hobbs Medical, Inc. recalls Hobbs Medical Polypectomy Snare Catalog Number: 4575-OLY

    Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and…

    FDA · DeviceHobbs Medical, Inc.Worldwide distribution - US Nationwide and the countries of Canada, Austria,…Official notice →
  7. US
    Drugs & medicalClass I

    Jiangsu Well Biotech Co.,Ltd. recalls Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02

    Distribution of COVID-19 Ag Rapid Test kits in the U.S. without an Emergency Use Authorization, or a Pre-Market Approval or Clearance.

    FDA · DeviceJiangsu Well Biotech Co.,Ltd.U.S.: CA (pending firm supplying additional distribution locations/consignee…Official notice →
See all drugs & medical recalls →