Drugs & medicalClass II

Covidien LP recalls Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT 88861919-51 SURGILON* 2-0…

Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma levels may decrease the strength of the sutures over time, which could result in harms such as wound…

Read the official notice →
Date
2024-02-07
Country
United States
Brand
Covidien
Product
Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT 88861919-51 SURGILON* 2-0…
Classification
Class II
Units
Worldwide US Nationwide distribution including in the states of AL, AZ, CA,…
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 Details may be shortened or out of date; the official notice is the authoritative source.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. 2024-04-10
  2. US
    Drugs & medicalClass II

    Covidien, LP recalls Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT

    Under certain firing conditions, reloads were found to articulate in an uncontrolled manner potentially causing disruption to the staple line. The issue is related to components in impacted reloads that are not fully…

    FDA · DeviceCovidien, LPWorldwide distribution - US Nationwide and the countries of France, Hong Kong,…Official notice →
  3. 2024-03-27
  4. US
    Drugs & medicalClass II

    Covidien recalls Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1

    Packs including 5 laparotomy sponges may contain incorrect product with a blue loop, X-ray detectable feature, and ethylene oxide treatment; however, this incorrect product wasn't steam pre-treated prior to…

    FDA · DeviceCovidienUS Nationwide distribution including in the states of AK, AL, AZ, CA, CO, FL,…Official notice →
  5. 2024-02-14
  6. US
    Drugs & medicalClass II

    Covidien LP recalls AbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks 5 mm- -intended for fixation of prosthetic material to soft tissue in…

    Packaging of the device may cause a low seal strength in the side seal of the foil pouch potentially resulting in a sterile/moisture barrier breach, compromising the product sterility

    FDA · DeviceCovidien LPUS Nationwide distribution in the states of CA, CO, FL, IL, TX.Official notice →
  7. 2024-01-10
  8. US
    Drugs & medicalClass II

    Covidien recalls Covidien Valleylab FT10, FT Series Energy Platform, REF: VLFT10GEN, DLVLFT10GEN, VLFT10GENZD

    Due to software issue, New systems may exhibit an error which may prohibit use of new systems resulting in system being inoperable

    FDA · DeviceCovidienWorldwide distribution - US: Nationwide and surrounding territories.Official notice →
  9. 2023-11-08
  10. US
    Drugs & medicalClass II

    Covidien recalls McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only

    Laryngoscope blades may contain an ineffective application of anti-fog agent which may result in condensation accumulating causing the screen to be blurred or obscured.

    FDA · DeviceCovidienUS: AK AL AR AZ CA CO CT DE FL GA IA IL IN KS LA MA MD MI MO MT NC ND NH NJ NM…Official notice →
  11. US
    Drugs & medicalClass I

    Covidien recalls Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000

    Defective video laryngoscopes that did not pass quality tests established for the product, that were designated for destruction, were stolen, and subsequently distributed for sale. Defective device use may result in…

    FDA · DeviceCovidienUnknownOfficial notice →
All 53 Covidien recalls →

Other drugs & medical recalls in the United States

  1. 2024-02-07
  2. US
    Drugs & medicalClass II

    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)

    Loss of connectivity between the FlexArm and the Table due to a software issue related to the date/time format. This connection issue leads to a loss of movement of the arm or table.

    FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide - US Nationwide distribution in the states of CO, FL, IL, MS, NV and…Official notice →
  3. US
    Drugs & medicalClass II

    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)

    Loss of connectivity between the FlexArm and the Table due to a software issue.

    FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide - US Nationwide distribution in the states of CO, FL, IL, MS, NV and…Official notice →
  4. US
    Drugs & medicalClass II

    XTANT Medical Holdings, Inc recalls Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length.

    Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length were manufactured using an incorrect screw shank component, and so the labeling is incorrect because the affected screws are in fact 5.5 diameter, 45 mm…

    FDA · DeviceXTANT Medical Holdings, IncUS distribution in MI.Official notice →
  5. US
    Drugs & medicalClass II

    FX SHOULDER recalls Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210

    Centered glenosphere box may contain an eccentric glenosphere.

    FDA · DeviceFX SHOULDERUS Nationwide distribution in the state of NJ.Official notice →
  6. US
    Drugs & medicalClass II

    TERRAGENE S.A. recalls Terragene Bionova PCD (PCD222-C)

    Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products.

    FDA · DeviceTERRAGENE S.A.U.S. Nationwide distribution in the states of GA, IN, MI, MT, NY, PA, TX and VA.Official notice →
  7. US
    Drugs & medicalClass II

    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion system, Interventional fluoroscopic x-ray system. System Product Name - Model Numbers Azurion 3M12…

    System may exhibit a loss of imaging functionality and data due to an issue which can cause the system to continuously restart. If the issue occurs during a procedure, there may be a delay and/or abortion of the…

    FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide - US Nationwide distribution.Official notice →
See all drugs & medical recalls →