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

Get instant alerts for Health & Personal Care recalls

Be the first to know. Free instant alerts to your inbox.

No spamUnsubscribe anytime

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.

The Hazard

Medline's recall follows BD's announcement regarding their Luer Tip Caps failing biocompatibility testing. While the tip cap does not contact patients directly, potential health risks include irritation and acute systemic toxicity.

Reported Incidents

There have been no reported injuries or incidents linked to this recall as of now. However, the potential for adverse reactions exists depending on contact duration.

What to Do

Stop using the perfusion syringe immediately. Follow the recall instructions from Medline Industries, LP. Contact your healthcare provider or Medline for further guidance.

Contact Information

For more details, contact Medline Industries, LP via email. Visit the FDA recall page for additional information.

Key Facts

  • Recall date: October 27, 2025
  • Quantity recalled: 15 units
  • Affected lot number: 25FMJ081
  • Risk of irritation and toxicity
  • No injuries reported

Get Alerts for Health & Personal Care Recalls

Get instant alerts for recalls that affect you. Free forever.

Safety Assessment

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

Product Classification

Product Details

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

Related Recalls

HIGH

Novo Nordisk Recalls Wegovy Injection Due to Contamination Risk

Novo Nordisk recalled Wegovy (semaglutide) Injection on December 19, 2025, due to hair found in a prefilled syringe. The recall affects products distributed nationwide in the United States. Consumers should stop using the product immediately and contact their healthcare provider.

Wegovy
Presence of
Read more
HIGH

Zydus Pharmaceuticals Recalls TraZODONE Tablets Over Defects

Zydus Pharmaceuticals recalled over 2,100 bottles of TraZODONE Hydrochloride Tablets on December 19, 2025. Some tablets have surface dents that may affect medication integrity. Consumers should stop using the product immediately and seek guidance from healthcare providers.

Zydus Pharmaceuticals
Failed Tablet/Capsule
Read more
HIGH

Merck Recalls Noxafil Oral Suspension Due to Metal Contamination

Merck Sharp & Dohme LLC recalled 845 kits of Noxafil Powdermix on December 12, 2025. The recall follows the discovery of potential metal particulates in the product. Consumers should stop using the medication immediately and contact their healthcare provider for further guidance.

NOXAFIL
Presence of
Read more
HIGH

Merck Emend Recalled Due to Potential Metal Contamination

Merck Sharp & Dohme LLC recalled 3 single-dose kits of Emend (aprepitant) on December 12, 2025. The recall stems from the potential presence of metal particulates in the medication. Consumers should immediately stop using the product and contact their healthcare provider for guidance.

EMEND
Presence of
Read more
HIGH

Beaver-Visitec Recalls Laser and Endoscopy System Over Safety Hazard

Beaver-Visitec International recalled five units of the OME6000U Laser and Endoscopy System on December 5, 2025. The recall stems from a manufacturing deviation where ferrites required for the USB cable were not installed. This omission poses a high electrical hazard risk to patients and healthcare providers.

Beaver-Visitec International
Manufacturing deviation
Read more