HIGH

Medline Recalls Perfusion Syringe Due to Biocompatibility Issues

Medline Industries, LP recalled 15 units of its perfusion syringe on October 27, 2025, due to potential biocompatibility failures. These failures may lead to risks of irritation and other serious health issues. Healthcare providers and patients must stop using the product immediately and follow the recall instructions.

Quick Facts at a Glance

Recall Date
October 27, 2025
Hazard Level
HIGH
Brand
Medline Industries, LP
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing BD Luer Tip Caps. BD has issued a recall of their Luer Tip Caps after confirming through internal testing that certain BD Luer Tip Cap trays failed routine biocompatibility testing. Although the tip cap covers a small surface area of the syringe and does not come in direct contact with patients, there is the potential that the failure of a biocompatibility test may have varying consequences ranging from no harm or clinical impact to potential for sensitization, irritation, pyrogenicity, acute systemic toxicity or hemolysis depending on the nature and duration of contact with the syringe.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medline Industries, LP or your healthcare provider for instructions. Notification method: E-Mail

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About This Product

The Medline perfusion syringe is used in various medical applications for delivering fluids. Consumers and healthcare providers purchase these syringes for their reliability in clinical settings.

Why This Is Dangerous

The recall is due to certain BD Luer Tip Caps failing biocompatibility testing, which could lead to health risks such as irritation or toxicity, despite not directly contacting patients.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

The recall requires immediate action from healthcare providers and patients to prevent potential health risks. It may cause inconvenience but is critical for safety.

Practical Guidance

How to identify if yours is affected

  1. Check the product packaging for lot number 25FMJ081.
  2. Verify if the syringe is part of the Medline perfusion syringe product line.
  3. Stop using the syringe immediately.

Where to find product info

The lot number is typically located on the packaging or the syringe itself.

What timeline to expect

Expect a refund or replacement processing time of 4-6 weeks after returning the product.

If the manufacturer is unresponsive

  • Contact Medline Industries via email for follow-up.
  • Reach out to your healthcare provider for assistance.

How to prevent similar issues

  • Look for syringes with certified biocompatibility labels in the future.
  • Choose products from reputable manufacturers with a history of compliance.
  • Consult healthcare professionals for recommendations on safe medical devices.

Documentation advice

Keep records of your purchase, including receipts and correspondence regarding the recall.

Product Details

The recalled product is the Medline Perfusion Syringe, REF: DYNJ39223C, with UDI/DI 10193489621532 for each unit and 40193489621533 for the case. The affected lot number is 25FMJ081. This product was distributed nationwide in the United States, particularly in California.

Key Facts

  • Recall date: October 27, 2025
  • Quantity recalled: 15 units
  • Affected lot number: 25FMJ081
  • Risk of irritation and toxicity
  • No injuries reported
View Original Recall on FDA - Medical Devices

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Safety Guide

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Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
7/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypePerfusion Syringe
Sold At
Multiple Retailers

Product Details

Model Numbers
UDI/DI 10193489621532 (each) 40193489621533 (case)
Lot Number 25FMJ081
Affected States
ALL
Report Date
December 17, 2025
Recall Status
ACTIVE

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