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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 INDUSTRIES, LP - Northfield: 4.5" Iris Scissors Recalled Due to Potential Sterile Barrier Compromise

Agency Publication Date: September 18, 2023
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Summary

Medline Industries is recalling approximately 324,451 units of the 4.5" Iris Sterile Curved Scissors (model DYNJ04049). These scissors were sold worldwide, including throughout the United States and Canada, between August 2023 and the present. The recall was initiated because the protective tip on the scissors can fall off, allowing the sharp blades to puncture the sterile packaging; these punctures may be too small for a user to see, which could lead to using a non-sterile instrument. If you have these scissors, contact your healthcare provider or Medline Industries for further instructions.

Risk

The sharp tip of the scissors can puncture the packaging if the tip protector falls off, compromising the sterile barrier. This poses a risk of infection or surgical site contamination because the device may no longer be sterile even if the packaging appears intact.

What You Should Do

  1. Check your medical supplies for Medline Sterile Iris Scissors (Curved/Standard) with the reference number DYNJ04049 and UDI/DI 10080196847273.
  2. Inspect all lots of this specific model, as all lot numbers are included in this recall.
  3. If you identify these scissors, contact Medline Industries or your healthcare provider immediately to determine if they should be returned or replaced.
  4. Do not use scissors if the tip protector is missing or if the sterile pouch appears punctured or compromised in any way.
  5. Contact Medline Industries, LP at their Northfield, Illinois headquarters or via the contact method provided in their initial email notification for further instructions regarding a potential refund or replacement.
  6. For additional information, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer Contact

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

Affected Products

Product: MEDLINE STERILE IRIS SCISSORS CVD/STD (4.5")
Model / REF:
DYNJ04049
REF DYNJ04049
UPC Codes:
10080196847273
Lot Numbers:
All lots

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92881
Status: Active
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Sold By: Hospital supply distributors; Medline Industries
Manufactured In: United States
Units Affected: 324,451 devices
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.