HIGH

Medline Recalls Sterile Convenience Kits Due to Sterilization Issue

Medline Industries recalled 22 sterile convenience kits on August 8, 2025, after discovering they had not been sterilized. The affected models include DYNJ0382730O and DYNJ61038B. This recall impacts states including Florida, Maryland, New Jersey, and Tennessee.

Quick Facts at a Glance

Recall Date
August 8, 2025
Hazard Level
HIGH
Brand
Medline Industries, LP
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
4 states
At-Risk Groups
GENERAL

Hazard Information

Convenience kits labeled as sterile have not gone through the sterilization process.

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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Product Details

The recall affects 22 units of two models: Major Pack L-F (Model Number: DYNJ0382730O) and LB Basic Custom Pack (Model Number: DYNJ61038B). These kits were distributed in Florida, Maryland, New Jersey, and Tennessee.

The Hazard

The convenience kits were labeled as sterile but did not undergo the sterilization process. This poses a risk of infection and other serious health complications.

Reported Incidents

No incidents or injuries have been reported related to this recall. However, the lack of sterilization presents a high risk.

What to Do

Stop using the recalled convenience kits immediately. Follow the manufacturer's recall instructions and contact Medline Industries or your healthcare provider for further instructions.

Contact Information

For more information, contact Medline Industries at their official website or email. Additional details are available on the FDA's recall report page.

Key Facts

  • 22 units recalled
  • Models: DYNJ0382730O, DYNJ61038B
  • Distributed in FL, MD, NJ, TN
  • Stop use immediately
  • Contact Medline for instructions

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
1) DYNJ0382730O
UDI-DI: 10198459117992(each)
40198459117993(case)
Lot Number: 25GBC583
2) DYNJ61038B
+3 more
Affected States
FL, MD, NJ, TN
Report Date
October 8, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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