HIGH

Medline Drape Pack Recalled Over Sterility Concerns

Medline Industries recalled 72 units of Drape Pack-Choice, Model DYNJ63118A, on January 7, 2026. Calibration issues in sterilization equipment may compromise product sterility. Patients and healthcare providers should stop using the device immediately.

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 Drape Pack-Choice is a medical device used in healthcare settings for surgical procedures. Consumers purchase this product for its convenience in sterile applications.

Why This Is Dangerous

The calibration issues in sterilization equipment may compromise the sterility of the Drape Pack-Choice, increasing the risk of infection during procedures.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Consumers using this product may face health risks due to compromised sterility. Immediate action is necessary to ensure patient safety.

Practical Guidance

How to identify if yours is affected

  1. Check the model number on the packaging for DYNJ63118A.
  2. Verify the lot number: 25ABV005.
  3. Ensure the product was purchased after January 7, 2026.

Where to find product info

The model number and lot number are typically found on the outer packaging or the product label.

What timeline to expect

Expect 4-6 weeks for refund processing after following recall instructions.

If the manufacturer is unresponsive

  • Follow up with Medline Industries via phone or email.
  • Document your communications with the company.
  • Consider reporting to CPSC if no response is received.

How to prevent similar issues

  • Look for FDA-approved medical devices in the future.
  • Check for recent recalls before purchase.
  • Verify product sterility certifications.

Documentation advice

Keep records of purchase receipts, recall notices, and correspondence with the manufacturer.

Product Details

The recalled product is Medline's Drape Pack-Choice, Model Number DYNJ63118A. It was distributed worldwide, including the US, but specific retailers are not identified. The recall affects 72 units.

Key Facts

  • Recall Date: January 7, 2026
  • Quantity Recalled: 72 units
  • Hazard Classification: Class II
  • Affected Model: DYNJ63118A
  • Reported incidents: None reported
View Original Recall on FDA - Medical Devices

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Safety Guide

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Read: What to Do When You Find a Recalled Product

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Safety Assessment

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

Product Classification

Product TypeDrape Pack
Sold At
Multiple Retailers

Product Details

Model Numbers
1) DYNJ63118A
UDI-DI: 10195327644291(each)
40195327644292(case)
Lot Number: 25ABV005
Affected States
ALL
Report Date
February 25, 2026
Recall Status
ACTIVE

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