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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.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Medline Iris Scissors Recalled Due to Potential Loss of Sterility

Agency Publication Date: November 14, 2024
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Summary

Medline Industries is recalling 69,611 units of its single-use curved Iris Scissors because a defect in the packaging may compromise the sterile seal. The tip protector on these 4.5-inch surgical scissors can fall off inside the package and puncture the sterile barrier system. Using non-sterile instruments during medical procedures can lead to serious patient infections, though no injuries or incidents have been reported to date.

Risk

The detached tip protector may puncture the packaging from the inside, causing the device to lose its sterility before use. If healthcare providers use these contaminated scissors during a procedure, patients may be exposed to pathogens that cause surgical site infections.

What You Should Do

  1. The recalled products are Medline Iris Scissors, Single-Use, Curved, Standard 4.5-inch, identified by Model Numbers DYNJ04049 (cases) or DYNJ04049H (individual units) and UDI-DI 10080196847273.
  2. Check your inventory for lot numbers 23GBV681, 23HBD138, 23IBF254, or 23LBJ787, which are the only batches affected by this recall.
  3. Stop using the recalled device immediately.
  4. Contact Medline Industries or your medical distributor to arrange for the return, replacement, or correction of the affected scissors.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Medline Iris Scissors, Single-Use, Curved, Standard 4.5 inch
Variants: Single-Use, Curved, 4.5 inch
Model / REF:
DYNJ04049
DYNJ04049H
Lot Numbers:
23GBV681
23HBD138
23IBF254
23LBJ787
UDI:
10080196847273

Model DYNJ04049 refers to cases; Model DYNJ04049H refers to eaches.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95671
Status: Active
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Sold By: Medline Industries; Medical distributors
Manufactured In: United States
Units Affected: 69,611
Distributed To: Alabama, Arkansas, Colorado, Connecticut, Florida, Iowa, Indiana, Kansas, Louisiana, Massachusetts, Missouri, North Carolina, New York, Oklahoma, Oregon, Rhode Island, Tennessee, Texas, Virginia, Washington, Wyoming

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.