US Recall News

United States Recall News Alerts for Recalled Drugs, Food, Products, & Vehicles

MENUMENU
  • Home
  • About
    • Advertise
  • Full Recall News Archive
    • Top Story

      J&J Settles Talc Mesothelioma Settlement

      By Sandra Dalton, Staff Writer On January 6, 2020, Superior Court Judge Stephen Kaus announced that Johnson & Johnsons (J&J) had agreed to … [Read More...]

      Mondelēz Global LLC Conducts U.S. Voluntary Recall of Four Carton Sizes of RITZ Peanut Butter Cracker Sandwiches Due to Labeling Error

      Summary Company Announcement Date: July 08, 2025 FDA Publish Date: July … [Read More...]

    • More Safety Articles
    • Federal Preemption of State Product Liability Law
  • Drug Recalls
    • Abilify
    • Benicar
    • Fluoroquinolones
    • Invokana
    • Lipitor
    • Nuplazid
    • Opioids
    • OxyContin
    • Pradaxa
    • Proton Pump Inhibitors (PPIs)
    • Risperdal
    • SSRI
    • Symptoms & Side Effects
    • Taxotere
    • Testosterone
    • Uloric
    • Valsartan
    • Xarelto
    • Zofran
  • Medical Devices
    • 3M Earplug
    • 3T Heater-Cooler System
    • Bair Hugger
    • Bipolar Hip System
    • Essure
    • Hip Replacements
    • Implanon
    • IVC Filters
    • Hernia Mesh
    • Power Morcellators
    • Shoulder Implants
    • Transvaginal Mesh
  • Food Recalls
    • FDA Press Releases
    • USDA Press Releases
  • Auto Recalls
    • Air Bags
    • Ignitions
    • NHTSA Press Releases
    • Off-Road Utility Vehicles
    • Snowmobiles
    • Tires
  • Other Products
    • Asbestos
    • Baby Products
    • Pet Products
    • Roundup
    • Talcum Powder
    • Toy Recalls
You are here: Home / Food Recalls / FDA Press Releases / Teleflex Announces Worldwide Recall of Gibeck® Iso-Gard® Filter

Teleflex Announces Worldwide Recall of Gibeck® Iso-Gard® Filter

November 2, 2022 By The FDA Leave a Comment

Summary

Company Announcement Date:
November 03, 2022
FDA Publish Date:
November 04, 2022
Product Type:
Medical Devices

Reason for Announcement:

Recall Reason Description

Bacterial and viral filters

Company Name:
Teleflex Incorporated
Brand Name:

Brand Name(s)

Gibeck® and Iso-Gard®

Product Description:

Product Description

Bacterial and viral filters


Company Announcement

WAYNE, Pa., Nov. 03, 2022 (GLOBE NEWSWIRE) — Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies for critical care and surgery, has announced a worldwide recall of affected lots of the below-referenced Gibeck® Iso-Gard® Filter products. The Gibeck® Iso-Gard® Filter is a bacterial and viral filter, intended for connection to respiratory equipment in intensive care units and operating theatres to protect the equipment from potential airborne contaminants.

If the filter splits or detaches during use, the functionality and efficiency of the device may be compromised, potentially resulting in a leakage and insufficient air supply to the patient with potential desaturation.

The products involved in the recall are listed below. Additional detail about how to identify the affected products is available in the recall letter.

Product Codes Commercial Name
19012 Iso-Gard® Filter S with Expandi-Flex/Elbow
19012T Iso-Gard® Filter S with Expandi-Flex/Elbow, Tethered Cap
191667-000100 Filter + Catheter Mount
19211; 19212 Iso-Gard® Filter S
19261; 19272 Iso-Gard® Filter S with Expandi-Flex
19261T; 19262T; 19272T Iso-Gard® Filter S with Expandi-Flex, Tethered Cap
19211T; 19212T Iso-Gard® Filter S, Tethered Cap
Note: This recall is for specific lots of the above-referenced product codes. Reference appendix 2 of the recall letter for a full list of affected lots.  

Teleflex initiated this voluntary recall on August 29, 2022 due to reports received indicating that the device split or detached during use. Teleflex is currently issuing an expansion to this recall to include additional lots. Select lots of the device manufactured between December 17, 2019 and March 26, 2022 are subject to this recall and its expansion. Teleflex requests that users immediately check their inventory for product within the scope of this recall. Users should immediately quarantine affected product, cease use and distribution, and follow further instructions outlined in the recall letter. Reference appendix 2 of the recall letter for a full list of affected lots.

As of October 6, 2022, a total of 38 complaints reporting the filter splitting or detaching have been received for the products in scope of this recall. Of these 38 complaints, 4 complaints reported injuries, including patient desaturation. No deaths or long-term patient injuries have been reported at this time.

On October 14, 2022, the U.S. Food and Drug Administration (FDA) classified the recall of Gibeck® Iso-Gard® Filters as a Class I recall. FDA defines a Class I recall as, “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”

Those who have affected product should immediately identify all patients that are currently exposed to use of this product, discontinue use, and return all affected product to Teleflex. The recall letter, with a full list of affected product codes and lot numbers, can be found at the following link: https://teleflex.widen.net/s/8qdzbmsdnm/fsn—eif-000513-01—recall-letter

Any person with questions may contact the company at 1-866-396-2111; 8am to 7pm, ET, Monday through Friday, or email recalls@teleflex.com.recalls@teleflex.com

Adverse reactions or quality problems experienced with the use of this product should be reported to Teleflex Customer Service using the contact information above or may also be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax. To report to FDA’s MedWatch Adverse Event Reporting program, complete and submit the report Online: www.fda.gov/medwatch/report.htm, or via Regular Mail or Fax. Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

About Teleflex Incorporated
Teleflex is a global provider of medical technologies designed to improve the health and quality of people’s lives. We apply purpose driven innovation – a relentless pursuit of identifying unmet clinical needs – to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular access, interventional cardiology and radiology, anesthesia, emergency medicine, surgical, urology and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. For more information, please visit teleflex.com.

Teleflex is the home of Arrow®, Deknatel®, LMA®, Pilling®, QuikClot®, Rüsch®, UroLift®, and Weck® – trusted brands united by a common sense of purpose.

Forward-Looking Statements
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. Any forward-looking statements contained herein are based on our management’s current beliefs and expectations, but are subject to a number of risks, uncertainties and changes in circumstances, which may cause actual results or company actions to differ materially from what is expressed or implied by these statements. These risks and uncertainties are identified and described in more detail in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K.

Teleflex, the Teleflex logo, Arrow, Deknatel, Gibeck, Iso-Gard, LMA, Pilling, QuikClot, Rüsch, UroLift, and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.
© 2022 Teleflex Incorporated. All rights reserved.

Contacts:
Teleflex Incorporated:
Lawrence Keusch
Vice President, Investor Relations and Strategy Development

John Hsu, CFA
Vice President, Investor Relations

investors.teleflex.com
610-948-2836


Company Contact Information

Share this:

  • Click to share on Facebook (Opens in new window) Facebook
  • Click to share on X (Opens in new window) X
  • Click to share on LinkedIn (Opens in new window) LinkedIn
  • Click to email a link to a friend (Opens in new window) Email
  • Click to print (Opens in new window) Print

Related

Filed Under: FDA Press Releases

About The FDA

The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services. It consists of the Office of the Commissioner and four directorates overseeing the core functions of the agency: Medical Products and Tobacco, Foods and Veterinary Medicine, Global Regulatory Operations and Policy, and Operations.

Leave a ReplyCancel reply

This site uses Akismet to reduce spam. Learn how your comment data is processed.

Facebook
Thomas Roney LLC
Economic Consulting

J&J Settles Talc Mesothelioma Settlement

January 15, 2020 By Advice Media

Mondelēz Global LLC Conducts U.S. Voluntary Recall of Four Carton Sizes of RITZ Peanut Butter Cracker Sandwiches Due to Labeling Error

July 8, 2025 By The FDA

509 Recalls Helmets Due to Risk of Head Injury

July 2, 2025 By The CPSC

SNLN Party Supply Toys Recalled Due to Ingestion Hazard; Risk of Serious Injury or Death; Federal Toy Standard Violation; Sold Exclusively on Amazon by Yiwu Dixikeji Douxiangongsi

July 2, 2025 By The CPSC

Hero Highlight

J&J Settles Talc Mesothelioma Settlement

January 15, 2020 By Advice Media

Trane Recalls Gas/Electric Packaged Units Due to Risk of Gas Leak, Fire Hazard

July 2, 2025 By The CPSC

Jeriflyer Pool Drain Covers Recalled Due to Risk of Serious Injury or Death from Entrapment Hazard; Violation of the Virginia Graeme Baker Pool and Spa Safety Act; Sold on Amazon by Junjuanshop

July 2, 2025 By The CPSC

Positec Recalls Electric Corded Chainsaws and Pole Saws Due to Laceration Hazard

July 2, 2025 By The CPSC

Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Cefazolin for Injection Due to Product Mispackaging

June 27, 2025 By The FDA

Shang Hao Jia, Inc. Issues Allergy Alert on Undeclared Sesame in Danshi Brand Spicy Shredded Tofu

June 25, 2025 By The FDA

J&J Settles Talc Mesothelioma Settlement

January 15, 2020 By Advice Media

Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Cefazolin for Injection Due to Product Mispackaging

June 27, 2025 By The FDA

Shang Hao Jia, Inc. Issues Allergy Alert on Undeclared Sesame in Danshi Brand Spicy Shredded Tofu

June 25, 2025 By The FDA

The Coleman Company Recalls Converta Camping Cots and Converta Camping Suspension Stretchers Due to Laceration and Amputation Hazards; Imported by Newell Brands

June 25, 2025 By The CPSC

Recall News in Your Inbox

Enter your email address to receive automated recall news updates.

Recent Comments

  • Roger McGowan on ABH NATURE’S PRODUCTS, INC, ABH PHARMA, INC., and STOCKNUTRA.COM, INC. Issues Nationwide Recall of All Lots of Dietary Supplement Products
  • Kathryn Moore on FDA Wants Cancer Warning on Breast Implants
  • BRAD on Huge ATV Recall by Polaris – Sportsman and Scrambler
  • Crystal Anderson on Allergan Voluntarily Recalls BIOCELL® Textured Breast Implants and Tissue Expanders
  • Outsourcing Training on The Modern Marketing of Pain
  • SANDRA Collett on Processed Food Preservative Linked to Autism?
  • Eric Karsh on Health Risks of Roundup Go Well Beyond Cancer

Recent Posts

  • Mondelēz Global LLC Conducts U.S. Voluntary Recall of Four Carton Sizes of RITZ Peanut Butter Cracker Sandwiches Due to Labeling Error
  • 509 Recalls Helmets Due to Risk of Head Injury
  • SNLN Party Supply Toys Recalled Due to Ingestion Hazard; Risk of Serious Injury or Death; Federal Toy Standard Violation; Sold Exclusively on Amazon by Yiwu Dixikeji Douxiangongsi
  • Harbor Freight Tools Recalls Predator 2000-Watt Power Stations Due to Shock Hazard
  • DEWALT Recalls Grinder Flap Discs Due to Laceration and Injury Hazards
  • Trane Recalls Gas/Electric Packaged Units Due to Risk of Gas Leak, Fire Hazard
  • Jeriflyer Pool Drain Covers Recalled Due to Risk of Serious Injury or Death from Entrapment Hazard; Violation of the Virginia Graeme Baker Pool and Spa Safety Act; Sold on Amazon by Junjuanshop
  • Positec Recalls Electric Corded Chainsaws and Pole Saws Due to Laceration Hazard
  • Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Cefazolin for Injection Due to Product Mispackaging
-- See More Recall News

Disclaimer: The information contained in these topics is not intended nor implied to be a substitute for professional medical or legal advice, it is provided for educational purposes only. Always seek the advice of your physician or other qualified healthcare provider about any questions you may have regarding a medical condition. Nothing contained in these topics is intended to be used for medical diagnosis or treatment.


ATTORNEY ADVERTISING. The information provided on this website is not legal advice. No attorney-client relationship is formed by the use of this site. It is not stated or implied that a lawyer is certified as a specialist in any particular field of law. No results are guaranteed, and prior results do not guarantee a similar outcome. This site is informational, only, not dispositive; it is up to you to decide whether a particular lawyer is right for you. Use of this site is subject to your agreement to these.


Copyright © 2025 Altrumedia · Terms of Service · Log in