Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy
Buy Me a Coffee

Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

ยฉ 2026 Go Backs. All rights reserved.

Medium RiskFDA Device
Medical Devices/Surgical Equipment

MEDLINE INDUSTRIES, LP - Northfield: Reprocessed Surgical Sealers and Dividers Recalled for Incomplete Packaging Seal

Agency Publication Date: October 16, 2023
Share:
Sign in to monitor this recall

Summary

Medline Industries is recalling 355 units of various reprocessed Covidien LigaSure and Ethicon Harmonic surgical instruments because the packaging trays may have an incomplete seal. These devices, which include various sealer/divider models and shears used in electrosurgical procedures, were distributed across the United States. If the packaging seal is compromised, the sterile barrier of the medical device may be broken, leading to a risk of contamination and serious infection during surgery.

Risk

An incomplete seal on the packaging tray can allow pathogens to enter the sterile container, potentially exposing patients to non-sterile instruments during surgical procedures. This poses a risk of post-operative infections or surgical site contamination.

What You Should Do

  1. Identify if you have the affected devices by checking the packaging for the following Reference (REF) and Lot Numbers: ReNewal Ligasure Blunt Tip Sealer (REF LF1844CR, Lot 498004), Maryland Jaw Sealer (REF LF1944CR, Lots 498006, 498837, 498838, 499150, 499151), Sealer/Divider (REF LF4418CR, 18 different lots including 498352 and 499343), and Harmonic ACE+7 Shears (REF HARH45R, Lots 498739, 498740, 499057, 499143, 499227).
  2. Verify the UDI/DI numbers on the individual units or cases, such as 10888277680418, 10888277719439, 10193489189759, or 10193489081336.
  3. If you identify any affected devices, do not use them in any surgical procedures and immediately quarantine the products to prevent accidental use.
  4. Contact Medline Industries, LP or your healthcare facility's risk management department for specific instructions on returning the affected products or obtaining replacements.
  5. Contact your healthcare provider or the manufacturer for further instructions regarding any potential clinical impact or to discuss the return of these medical devices.
  6. For additional information or questions regarding this recall, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Product quarantine and potential replacement

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: MEDLINE ReNewal Ligasure Blunt Tip Sealer/Divider Nano-Coated Compatible with FT10 Generator
Model / REF:
REF LF1844CR
Lot Numbers:
498004
Product: MEDLINE ReNewal Ligasure Maryland Jaw Sealer/Divider Nano-Coated Compatible with FT10 Generator
Model / REF:
REF LF1944CR
Lot Numbers:
498006
498837
498838
499150
499151
Product: MEDLINE ReNewal Ligasure Sealer/Divider Nano-Coated Compatible with FT10 Generator
Model / REF:
REF LF4418CR
Lot Numbers:
498352
498405
498459
498890
498937
499048
499050
499052
499062
499063
499145
499155
499218
499267
499269
499271
499299
499343
Product: MEDLINE ReNewal Harmonic ACE+7 Shears w/ Adv. Hemostasis
Model / REF:
REF HARH45R
Lot Numbers:
498739
498740
499057
499143
499227

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92920
Status: Active
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Sold By: Hospitals; Surgical Centers; Medical Distributors
Manufactured In: United States
Units Affected: 4 products (11 units; 58 units; 268 units; 18 units)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.