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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Medline Industries, LP
- Product type
- Perfusion Syringe
- Model numbers
- UDI/DI 10193489621532 (each) 40193489621533 (case), Lot Number 25FMJ081
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
October 27, 2025
Reported by FDA DEVICE
December 17, 2025
RecallRadar source check
December 24, 2025
Consumer action
Use the official remedy and keep documentation.
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
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
- Check the product packaging for lot number 25FMJ081.
- Verify if the syringe is part of the Medline perfusion syringe product line.
- 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.
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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
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