What should I do if I have one of the recalled surgical packs?

Stop using the recalled surgical packs immediately and follow the recall instructions provided by Medline. Contact Medline Industries or your healthcare provider for further guidance.

How can I identify if my surgical pack is affected by the recall?

Check the model numbers: DYNJP1050UG and DYNJP8401. Also, look for specific lot numbers listed in the recall notice.

Is there any risk associated with using these surgical packs?

Yes, the calibration issues with sterilization equipment may compromise the sterility assurance level of the products, posing health risks.

What if I don't have my receipt? Can I still get a refund?

Yes, consumers have the right to a full refund regardless of receipt for recalled products.

How long will it take to process my refund?

Typically, expect a refund processing time of 4 to 8 weeks after you submit your request.

Where can I find more information about this recall?

For more details, visit the FDA recall page or contact Medline Industries directly.

Can I continue using the surgical pack if it looks fine?

No, you should not use the surgical pack as the calibration issues may compromise its sterility.

What is the sterility assurance level (SAL)?

SAL refers to the probability of a viable microorganism being present on a product after sterilization. Compromised SAL means the product may not be safe for use.

What is the classification of this recall?

This recall is classified as Class II, indicating a situation in which use of the product may cause temporary or medically reversible adverse health consequences.

Will I be notified if my product is affected?

Yes, Medline will notify affected consumers via letter.

What should I document for my records regarding this recall?

Keep records of your communications with Medline, including any letters received, as well as photos of the product if possible.

HIGHJanuary 7, 2026

Medline Surgical Packs Recalled Over Sterility Concerns

Medline Industries recalled 193,157 surgical packs on January 7, 2026, due to sterility assurance issues. The recall affects two model numbers: DYNJP1050UG and DYNJP8401. Healthcare providers and patients must stop using these products 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

Medline's surgical packs are used in medical procedures to ensure that instruments and surgical fields are sterile. Consumers purchase these packs for their reliability in providing a sterile environment during surgeries.

Why This Is Dangerous

The calibration issues with sterilization equipment may lead to non-sterile products being used in medical settings, increasing the risk of infection or complications post-surgery.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Consumers must stop using the affected surgical packs immediately, which may disrupt medical procedures and require alternatives to be sourced quickly.

Practical Guidance

How to identify if yours is affected

Check the model number on the packaging: DYNJP1050UG or DYNJP8401.
Verify the lot numbers against the recall notice.
Contact Medline Industries if in doubt about your product.

Where to find product info

Model numbers and lot numbers can typically be found on the packaging or product labels.

What timeline to expect

Expect a refund or replacement to be processed within 4 to 8 weeks after submission.

If the manufacturer is unresponsive

Document your communications with Medline.
Reach out via alternative contact methods if you do not receive a response.

How to prevent similar issues

Look for products with clear sterilization validation certifications.
Ensure that products come from reputable manufacturers with a good safety record.
Check for recent recall notices before purchasing medical supplies.

Documentation advice

Keep copies of any correspondence with Medline and photographs of the product as evidence in case of issues.

Product Details

The recall includes two models of surgical packs: Universal Ultraguard Pack (Model Number: DYNJP1050UG) and Shoulder Drape Pouch Pack (Model Number: DYNJP8401). These products were distributed worldwide, including the US, and are packaged in units of 5 and 10 respectively.

Key Facts

193,157 surgical packs recalled
Calibration issues may affect sterility
Contact Medline for further instructions
Stop using affected products immediately
Recall initiated on January 7, 2026

View Original Recall on FDA - Medical Devices

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Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

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

CategoryHealth & Personal Care › Medical Devices

Product TypeSurgical Pack

Product Details

Brand

Medline Industries, LP

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