HIGH

Medline Dental Pack Recalled Over Sterility Concerns

Medline Industries recalled 2,236 dental packs on January 7, 2026, due to calibration issues affecting sterilization. The recall impacts products distributed worldwide, raising safety concerns for healthcare providers. Consumers should stop using the recalled items immediately and follow manufacturer instructions.

Quick Facts at a Glance

Recall Date
January 7, 2026
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 has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

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: Letter

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About This Product

The Medline Dental Pack is a medical device used in dental procedures to ensure hygienic practices. Healthcare providers purchase these kits for their sterile instruments and supplies, essential for patient safety.

Why This Is Dangerous

Calibration issues with the sterilization equipment may lead to compromised sterility levels. This increases the risk of infections if the products are used on patients.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Patients relying on these dental packs may face increased health risks if the products are not properly sterilized. The recall necessitates immediate action from users.

Practical Guidance

How to identify if yours is affected

  1. Check the model number for DYNDA3003.
  2. Review lot numbers against the recalled list.
  3. Consult with your healthcare provider if unsure.

Where to find product info

Look for the model and lot numbers on the product packaging.

What timeline to expect

Expect a processing time of 4-6 weeks for refunds and replacements after contacting Medline.

If the manufacturer is unresponsive

  • Follow up with Medline customer service.
  • Document your request and any communication.

How to prevent similar issues

  • Always verify the recall status of medical supplies before use.
  • Check for certification seals and expiration dates on medical devices.
  • Purchase from reputable suppliers to ensure product safety.

Documentation advice

Keep a copy of the recall notice, any correspondence with Medline, and records of your purchase.

Product Details

The recalled product is the Medline Dental Pack, Model Number DYNDA3003. It was distributed worldwide, including across the United States. The total quantity recalled is 2,236 units.

Key Facts

  • Recall date: January 7, 2026
  • Quantity recalled: 2,236 units
  • High hazard level due to sterility risks
  • Stop using the product immediately
  • Contact Medline for further instructions
View Original Recall on FDA - Medical Devices

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Safety Guide

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Safety Assessment

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

Product Classification

Product TypeDental Pack
Sold At
Multiple Retailers

Product Details

Model Numbers
1) DYNDA3003
UDI-DI: 10195327257484(each)
40195327257485(case)
Lot Number: 24EMC989
2) DYNDA3003
+7 more
Affected States
ALL
Report Date
February 25, 2026
Recall Status
ACTIVE

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