Drugs & medicalClass II

Covidien, LP recalls Sofsilk Braided Silk sutures, Product Number S-2782K. Nonabsorbable, sterile, non-mutagenic surgical suture composed of natural silk…

One lot of product was exposed to more than the approved number of Ethylene Oxide (EO) sterilization cycles. This may decrease the tensile strength of the sutures over time, which could result in harms such as wound…

Read the official notice →
Date
2024-05-08
Country
United States
Brand
Covidien
Product
Sofsilk Braided Silk sutures, Product Number S-2782K. Nonabsorbable, sterile, non-mutagenic surgical suture composed of natural silk…
Classification
Class II
Units
International distribution in the countries of Portugal and Italy.
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 Details may be shortened or out of date; the official notice is the authoritative source.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. 2024-06-19
  2. US
    Drugs & medicalClass II

    Covidien, LLC recalls EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only

    Due to saline conductivity issues, their is a potential that dilation catheters may provide inaccurate esophageal diameter measurements that may lead to various harms.

    FDA · DeviceCovidien, LLCWorldwide - US Nationwide distribution including in the states of AK, AL, AZ,…Official notice →
  3. 2024-06-05
  4. US
    Drugs & medicalClass II

    Covidien, LP recalls Tri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal, gynecologic, pediatric and thoracic surgery for resection,…

    Potential damage to the cartridge can result in poor staple formation and/or incomplete staple line, may cause a delay in surgery

    FDA · DeviceCovidien, LPWorldwide - US Nationwide distribution in the state of NJ and the countries of…Official notice →
  5. 2024-05-08
  6. US
    Drugs & medicalClass II

    Covidien recalls Medtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100, REF: PMAC71RIC

    manufacturing defects to sensor cable connectors may result in error codes or non-functioning channel

    FDA · DeviceCovidienUS: AK AZ CA CT FL GA IA IN LA MA MD MI MN MO NC NY OH OK PA SC TN TX VA WA WI…Official notice →
  7. 2024-05-01
  8. US
    Drugs & medicalClass II

    Covidien LP recalls Palindrome Precision HSI Chronic Catheter Sport Pack 14.5 Fr/Ch (4.8mm) x 19 cm (Symmetrical Tip, Heparin Coating, Silver Ion Sleeve and…

    Products may not be heparin coated as indicated on the label-leads to a potential loss of benefit due to the absence of the heparin coating

    FDA · DeviceCovidien LPWorldwide distribution - US Nationwide and the countries of Austria, Belgium,…Official notice →
  9. 2024-04-10
  10. US
    Drugs & medicalClass II

    Covidien, LP recalls Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BT

    The potential for trocar seal disengagement when using mesh products incorrectly with the device.

    FDA · DeviceCovidien, LPWorldwide distribution - US Nationwide and the countries of Albania, Algeria,…Official notice →
  11. 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 →
All 53 Covidien recalls →

Other drugs & medical recalls in the United States

  1. 2024-05-08
  2. US
    Drugs & medicalClass II

    Alere San Diego, Inc. recalls Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170

    There is a potential that the Cholestech LDX battery (an external battery pack available as an optional accessory to the Cholestech LDX Analyzer) may swell which could cause minor burns, cuts or abrasions, or low…

    FDA · DeviceAlere San Diego, Inc.Worldwide distribution - US Nationwide and the countries of United Kingdom,…Official notice →
  3. US
    Drugs & medicalClass II

    Olympus Corporation of the Americas recalls POWERSEAL 5 mm, 44 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such…

    Upon initial activation of the seal function, the POWERSEAL non-conformance results in an immediate Incomplete Seal Cycle tone with the accompanying message on the generator screen, and no energy would be delivered to…

    FDA · DeviceOlympus Corporation of the AmericasWorldwide distribution - US Nationwide and the countries of AU, CA, HK, KR.Official notice →
  4. US
    Drugs & medicalClass II

    Advanced Research Medical, LLC recalls ADVANCED RESEARCH MEDICAL Lumbar Interbody Fusion System (OLLIF), Flexible Curette Loop Blade, Part # 01-06-4; treatment of…

    Potential shearing of the disposable blade may occur and be contained within the of Flexible Curette Shaft Assembly during surgery.

    FDA · DeviceAdvanced Research Medical, LLCUS Nationwide distribution in the state of Minnesota.Official notice →
  5. US
    Drugs & medicalClass II

    Advanced Instruments, LLC recalls OsmoPRO MAX Automated Osmometer- IVD Osmometer for Clinical Use. Uses the method of freezing point depression to measure osmolality of…

    System error messages may delay the ability to test patient samples and the need for frequent calibration due to results outside the expected range when testing controls.

    FDA · DeviceAdvanced Instruments, LLCWorldwide distribution - US Nationwide and the countries of Canada, Czech…Official notice →
  6. US
    Drugs & medicalClass II

    Abbott Medical recalls Abbott Aveir Leadless Pacemaker, REF: LSP112V, STERILEEO

    Their is a potential that electromagnetic interference may cause leadless pacemaker may result in mode change.

    FDA · DeviceAbbott MedicalUS Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT,…Official notice →
  7. US
    Drugs & medicalClass II

    Allergan Sales, LLC recalls Keller Funnel 2, REF: HA-001, STERILEEO, Rx Only,

    Their is a potential that breast implants lack the lubricious coating that allows them to slide through the funnels during the implantation procedure.

    FDA · DeviceAllergan Sales, LLCUS Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO,…Official notice →
See all drugs & medical recalls →