Drugs & medicalClass II

Cordis US Corp recalls PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System, Catalog numbers PG2990BPS, PG2990BPX, PG3990BPS, PG3990BPX.

Potential for stent dislodgement and associated failures related to two specific sizes of the device.

Read the official notice →
Date
2022-07-20
Country
United States
Brand
Cordis
Product
PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System, Catalog numbers PG2990BPS, PG2990BPX, PG3990BPS, PG3990BPX.
Classification
Class II
Units
US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DC, DE,…
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 Details may be shortened or out of date; the official notice is the authoritative source.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 Cordis recalls

  1. 2025-03-19
  2. US
  3. 2024-01-17
  4. US
    Drugs & medicalClass II

    Cordis US Corp recalls MYNXGRIP 5F, REF MX5021, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites.

    Cordis became aware that the label for the carton box containing 10 units is incorrect for some boxes of two lots of MynxGrip. The carton box from lot F2322902 (Item MX5021, MynxGrip 5F) as labeled as lot F2322903…

    FDA · DeviceCordis US CorpUS: NC, WV, TN, MS, MI, OH, CAOfficial notice →
  5. 2023-11-15
  6. US
    Drugs & medicalClass I

    Cordis US Corp recalls Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208, cardiac catheter

    Non-sterile product labeled as sterile was distributed.

    FDA · DeviceCordis US CorpUS Distribution to: OKOfficial notice →
  7. 2023-05-17
  8. US
    Drugs & medicalClass I

    Cordis US Corp recalls ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814REC

    There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unplanned percutaneous or surgical…

    FDA · DeviceCordis US CorpWorldwide distribution.Official notice →
  9. 2022-12-21
  10. US
    Drugs & medicalClass II

    Cordis US Corp recalls Cordis Angiographic Catheter Extensions. Used to transport fluid from the power injector to the catheter for injection into the patient.

    There is a potential for separation at the male connector.

    FDA · DeviceCordis US CorpNationwide distribution to AZ, CA, DC, FL, GA, KY, LA, MD, MS, NY, OH, TX, WV,…Official notice →
  11. 2021-11-24
  12. US
    Drugs & medicalClass II

    Cordis Corporation recalls SMART FLEX 6x150 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in…

    There is a potential for distal tip dislodgement or separation.

    FDA · DeviceCordis CorporationUS Distribution to states of: CA, FL, IN, LA, OH, OK, TX and OUS distribution…Official notice →
All 8 Cordis recalls →

Other drugs & medical recalls in the United States

  1. 2022-07-20
  2. US
    Drugs & medicalClass II

    Wright Medical Technology, Inc. recalls Wright EVOLVE TRIAD Plate Cutter, REF 49510120

    The plate cutter is unable to meet sterilization requirements when it is sterilized in a double-wrapped configuration according to the Option 1 Steam Sterilization parameters detailed in instructions for use

    FDA · DeviceWright Medical Technology, Inc.Nationwide and PR, and Australia, Canada, Chile, Colombia, Hong Kong, Puerto…Official notice →
  3. US
    Drugs & medicalClass II

    Draeger Medical Systems, Inc. recalls Draeger Globe-Trotter and Globe-Trotter IC, Model numbers MS20508 and MS20509. neonatal transport system

    The firm has initiated this recall to replace component on devices distributed containing a component within the oxygen supply system that is not rated to the working pressure of the system.

    FDA · DeviceDraeger Medical Systems, Inc.No US distribution. Foreign distribution to BY, CL, DE, ES, GB, HU, IN, IT,…Official notice →
  4. US
    Drugs & medicalClass II

    Fresenius Medical Care Holdings, Inc. recalls AquaBplus Water Purification System, Part Number 24-2000-0, AquaBplus 2500 - Typ USA (G02040108-US), AquaBplus 2000 - Typ…

    AquaBplus HF module on the AquaBplus 2000 osmosis system, an error in the US Installation Guideline instructed that 3-ring mains, instead of 2-ring mains, may be installed in combination with an AquaBplus 2000 device.…

    FDA · DeviceFresenius Medical Care Holdings, Inc.US Nationwide distribution in the states of NC and WV.Official notice →
  5. US
    Drugs & medicalClass II

    Cook Incorporated recalls Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838

    The products may contain excess coating material on the outside and/or interior of the needle component. Potential adverse events that may occur if an affected product is used include a delay in the procedure, a…

    FDA · DeviceCook IncorporatedUS Nationwide. Brazil, Canada,Official notice →
  6. US
    Drugs & medicalClass II

    SCIENCE & BIO MATERIALS recalls ComposiTCP 30 Interference screw D 7- L:25 mm, REF 110004605

    Mislabeled product.

    FDA · DeviceSCIENCE & BIO MATERIALSUS Nationwide distribution.Official notice →
  7. US
    Drugs & medicalClass II

    Isopure Corp recalls Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO)

    Isopure received a report of a hazardous incident involving a device which had experienced an electrical short that resulted in a thermal event, damaging some of the device components. The firm is alerting customers to…

    FDA · DeviceIsopure CorpDomestic distribution to AL AZ CO DE FL GA IN KS KY LA MA MD ME MN MO NC NY OK…Official notice →
See all drugs & medical recalls →