Drugs & medicalClass II

Covidien, LLC recalls COVIDIEN Emprint Ablation Catheter with Thermosphere Technology, Bronchoscopic Ablation, REF CA108L1

The product is labeled with the incorrect expiration date.

Read the official notice →
Date
2023-01-18
Country
United States
Brand
Covidien
Product
COVIDIEN Emprint Ablation Catheter with Thermosphere Technology, Bronchoscopic Ablation, REF CA108L1
Classification
Class II
Units
Foreign Distribution: Hong Kong
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 Details may be shortened or out of date; the official notice is the authoritative source.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 Covidien recalls

  1. 2023-03-15
  2. US
    Drugs & medicalClass II

    Covidien, LP recalls Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT

    Affected lots have the potential for a broken sled vane, which may cause the reload to misfire leading to non-functional staple line closure, transecting tissue without forming staples, and tissue hang-up. These…

    FDA · DeviceCovidien, LPWorldwide distribution - US Nationwide distribution in the states of Arkansas,…Official notice →
  3. 2023-03-08
  4. US
    Drugs & medicalClass II

    Covidien, LP recalls Parietex Composite Mesh Polyester with Absorbable Collagen Film, Horseshoe- Shaped, 9 x 8 cm (3.6" x 3.1"). Intended for the reinforcement…

    Collagen film was placed on the opposite side of the mesh may cause delay to treatment/therapy, adhesions, erosion/migration, pain, fistula, hernia (recurrence), and failure of implant

    FDA · DeviceCovidien, LPUS Distribution to states of: CA, GA, NY and OUS Foreign distribution to…Official notice →
  5. US
    Drugs & medicalClass II

    Covidien, LP recalls Surgilon Braided Nylon suture Product Description: 88861883-51 SURGILON* 2-0 BLK 75CM C16 88861915-71 SURGILON* 1 BLK 75CM GS11…

    Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

    FDA · DeviceCovidien, LPUS Nationwide Distribution and OUS Foreign distribution to countries of:…Official notice →
  6. 2023-01-18
  7. US
    Drugs & medicalClass I

    Covidien LP recalls MAHURKAR 13.5Fr High Flow Dual Lumen Acute Dialysis Catheter, Sterile, Single Use, Rx Only: 13.5cm, Straight Extensions, Kit - Model No.…

    There is a potential leaking condition within the hub of affected devices, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.

    FDA · DeviceCovidien LPWorldwide distribution. US nationwide including Guam, USVI, and Puerto Rico;…Official notice →
  8. 2022-11-23
  9. US
    Drugs & medicalClass II

    Covidien, LP recalls Endo Stitch V-Loc 180 Absorbable Reload, Models VLOCA004L, VLOCA006L, VLOCA008L, VLOCA204L, VLOCA206L, VLOCA208L, VLOCA304L, VLOCA306L,…

    Medtronic has received 210 reports of needles breaking during endoscopic suturing. The potential harm(s) include a delay in treatment/therapy, the potential for a portion of the needle to remain in the patient, foreign…

    FDA · DeviceCovidien, LPDomestic distribution nationwide. Foreign distribution to Australia Austria…Official notice →
  10. 2022-09-28
  11. US
    Drugs & medicalClass II

    Covidien Llc recalls Puritan Bennett 560 Ventilator, PB560, CFN 4096600

    Medtronic has confirmed six reports from customers outside the US where the ventilator became inoperable due to loss of gas supply caused by manufacturing error of specific turbine components.

    FDA · DeviceCovidien LlcDomestic distribution to one customer in Washington, D.C. Foreign distribution…Official notice →
All 53 Covidien recalls →

Other drugs & medical recalls in the United States

  1. 2023-01-25
  2. US
  3. US
    Drugs & medicalClass I

    Accord Healthcare, Inc. recalls Daptomycin for Injection 350 mg/vial 1 Single-dose vial, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703…

    Labeling mixup: cartons labeled as Daptomycin 350 mg/vial were found to contain vials of Daptomycin 500 mg per vial

    FDA · DrugAccord Healthcare, Inc.Nationwide within the United StatesOfficial notice →
  4. US
    Drugs & medicalClass II

    Fresenius Kabi USA, LLC recalls Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.5%, 250 mg per 50 mL (5 mg per…

    Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.

    FDA · DrugFresenius Kabi USA, LLCNationwide in the USAOfficial notice →
  5. 2023-01-18
  6. US
    Drugs & medicalClass II

    CoreLink LLC recalls CoreLink LLC, FLXFIT 15, 32MM X 8MM, CAGE, REF: AT3208

    Specific lots of FLXfit implants have internal components that may have been manufactured using stainless steel rather than the specified titanium alloy.

    FDA · DeviceCoreLink LLCUS Nationwide distribution.Official notice →
  7. US
    Drugs & medicalClass II

    Medtronic Navigation, Inc. recalls RadiaLux Lighted Retractor (Pink), REF: 50-101-1

    Defect in sterile pouch seal, incomplete seal, of lighted Retractors, increases the risk of contamination, which can lead to post-operative infection.

    FDA · DeviceMedtronic Navigation, Inc.US Nationwide distribution including in the states of OH, CA, FL, NJ, NY, MN,…Official notice →
  8. US
    Drugs & medicalClass II

    Roche Diagnostics Operations, Inc. recalls cobas infinity central lab, Material Number 07154003001

    A complaint investigation revealed that an incorrect behavior relating to the rejection of orders capability of the Host Connectivity Agent (HCA) could occur where the order received from the Laboratory Information…

    FDA · DeviceRoche Diagnostics Operations, Inc.Domestic distribution nationwide. Foreign distribution pending.Official notice →
See all drugs & medical recalls →