HIGH

Medline Recalls Sterile Convenience Kits Due to Sterilization Failure

Medline Industries recalled 88 units of its Sterile Convenience Kits on August 8, 2025. The kits were labeled as sterile but did not undergo the required sterilization process. Healthcare providers and patients must stop using these kits immediately.

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

Product Details

The recall affects the EXTREMITY PACK, Model Number DYNJ45701B. The kits were distributed in Florida, Maryland, New Jersey, and Tennessee. The recall includes 88 units in total.

The Hazard

The convenience kits, labeled as sterile, failed to go through the sterilization process. This poses a significant risk of infection for patients.

Reported Incidents

No incidents or injuries have been reported at this time. The high hazard classification indicates potential risks associated with the use of non-sterile medical devices.

What to Do

Stop using the recalled convenience kits immediately. Contact Medline Industries for further instructions on returning the product and obtaining a refund.

Contact Information

For more information, contact Medline Industries at the email provided in their recall notification.

Key Facts

  • Recall date: August 8, 2025
  • Affected states: Florida, Maryland, New Jersey, Tennessee
  • Total units recalled: 88
  • Hazard classification: Class I

Safety Assessment

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

Product Classification

Product Details

Model Numbers
1) DYNJ45701B
UDI-DI: 10193489856279(each)
40193489856270(case)
Lot Number: 25GBF686
Affected States
FL, MD, NJ, TN
Report Date
October 8, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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