Drugs & medicalClass II

Covidien, LP recalls EEA Autosuture Circular Stapler with DST Series Technology, 25mm. Model Numbers EEA25, EEAXL25, EEA2535, and EEAXL2535.

The affected staplers have the potential for the staple guide to not be securely attached to the instrument. The issue could cause the component to disengage and if disengaged, could allow the device to transect tissue…

Read the official notice →
Date
2022-07-13
Country
United States
Brand
Covidien
Product
EEA Autosuture Circular Stapler with DST Series Technology, 25mm. Model Numbers EEA25, EEAXL25, EEA2535, and EEAXL2535.
Classification
Class II
Units
Worldwide distribution - US Nationwide.
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 Details may be shortened or out of date; the official notice is the authoritative source.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. 2022-11-23
  2. 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 →
  3. 2022-09-28
  4. 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 →
  5. 2022-08-03
  6. US
    Drugs & medicalClass II

    Covidien Llc recalls TruClear Hysteroscopic Tissue Removal System Control Unit- designed to meet the requirements of intrauterine tissue removal. Model Number:…

    Electrical component failure within the control unit. The observed failure mode is a loss of function of the device when used with handpiece and foot switch.

    FDA · DeviceCovidien LlcAZ CA CO IL KS MA MI MN MO NY OK PA TN TX TX WA Foreign: United Kingdom…Official notice →
  7. 2022-07-13
  8. US
    Drugs & medicalClass I

    Covidien Llc recalls Palindrome Precision Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis,…

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

    FDA · DeviceCovidien LlcWorldwide distribution - US Nationwide distribution in the states of AK, AL,…Official notice →
  9. 2022-02-09
  10. US
    Drugs & medicalClass II

    Covidien Llc recalls Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm, Chameleon PTA Balloon Catheter with Injection Port 8 mm x 40 mm; Cardiovascular.…

    The firm has received six (6) complaint reports from customers indicating difficulty removing the balloon protector sleeve from the catheter (e.g., excessive force required to remove the protector sleeve). If the…

    FDA · DeviceCovidien LlcWorldwide distribution - US Nationwide and the countries of Germany, Israel,…Official notice →
  11. 2022-01-26
  12. US
    Drugs & medicalClass II

    Covidien, LP recalls SonarMed AirWave Monitor Kit (Monitor, Sensor Cable, Power Cord), Item Code AW-M0001. used with endotracheal tube (ETT)

    Prior to use on a patient, the device alarm speaker failed to annunciate on power up and the device falsely detected a sensor cable disconnect and reconnect during setup. The monitor detection of a false sensor cable…

    FDA · DeviceCovidien, LPThe devices were distributed to the following US states: CA, CO, FL, IL, KY,…Official notice →
All 53 Covidien recalls →

Other drugs & medical recalls in the United States

  1. 2022-07-13
  2. US
    Drugs & medicalClass II

    Arcoma AB recalls Omnera 400A Digital Radiographic System

    There is the potential for the X-Ray system to short circuit due to an ingress of liquid in the display handles which may result in uncontrolled movement of the Overhead Tube Crane (OTC).

    FDA · DeviceArcoma ABUS Nationwide distribution in the states of NM, DE, TX, VT, FL, MO, UT, PA,…Official notice →
  3. US
    Drugs & medicalClass II

    Ossur Americas recalls OSSUR VARIFLEX SUBA JUNIOR foot and ankle external prosthesis, sized for children and adolescents.

    Due to receiving complaints related to broken (cracked) prosthetic foot with failures occurring in situations where sudden high impact twisting or bending is applied to the foot.

    FDA · DeviceOssur AmericasWorldwide distribution including US nationwide (including Puerto Rico).Official notice →
  4. US
    Drugs & medicalClass II

    DePuy Spine, Inc. recalls EIT CIF cage, H 7mm, 8degree, S- an intervertebral body fusion devices indicated for use with autograft when used as an adjunct to fusion…

    Label on the Outer Carton does not match the labels on the Outer Blister package, Inner Blister package and Patient Labels. The only label that may not be correct is on the Outer Carton

    FDA · DeviceDePuy Spine, Inc.Distribution US NationwideOfficial notice →
  5. US
    Drugs & medicalClass II

    Radiometer Medical ApS recalls ABL800 Flex Analyzer Model Numbers 393-800 and 393-801

    There is a potential for sporadic incidents of positive and negative biases for analyzer systems configured with cNa+, cCa+, and cK+.

    FDA · DeviceRadiometer Medical ApSWorldwide distribution - US Nationwide distribution in the states of AR, AZ,…Official notice →
  6. US
    Drugs & medicalClass I

    Covidien Llc recalls Palindrome Precision Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis,…

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

    FDA · DeviceCovidien LlcWorldwide distribution - US Nationwide distribution in the states of AK, AL,…Official notice →
  7. US
    Drugs & medicalClass II

    Fresenius Medical Care Holdings, Inc. recalls NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3

    The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging. Leaks can lead to biological contamination and therefore an increased risk of potential bloodstream…

    FDA · DeviceFresenius Medical Care Holdings, Inc.US Nationwide distribution in the states of Texas and Louisiana.Official notice →
See all drugs & medical recalls →