What should I do with a recalled Medline lithotomy pack?

Stop using the recalled lithotomy packs immediately. Contact Medline Industries or your healthcare provider for further instructions.

How do I know if my lithotomy pack is affected?

Check the model numbers DYNJ83185 and DYNJ83185A, along with their lot numbers to see if they match the recalled products.

What are the risks associated with the recalled lithotomy packs?

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

Is there a refund available for recalled products?

Yes, consumers can expect a refund or replacement as per the recall instructions provided by Medline.

Where can I find more information about this recall?

More details about the recall can be found on the FDA's recall page linked in the recall announcement.

What is the sterility assurance level (SAL) and why is it important?

SAL is a measure of the effectiveness of sterilization processes. A compromised SAL may lead to inadequate sterilization, posing infection risks.

How long will it take to process my refund for the recalled product?

Typically, the refund processing time can take between 4 to 6 weeks.

What documentation do I need to provide for a refund?

Keep your receipts and any correspondence with Medline as documentation for your refund request.

Can I still use the recalled lithotomy packs if they look fine?

No, do not use the recalled lithotomy packs, as the calibration issues affect their sterility and safety.

What if Medline does not respond to my refund request?

If you do not receive a response, document your communications and consider reaching out again or filing a complaint with consumer safety authorities.

HIGHJanuary 7, 2026

Medline Recalls Lithotomy Packs Over Sterility Concerns

Medline Industries recalled 808 lithotomy packs on January 7, 2026, due to calibration issues in sterilization equipment. These problems may compromise the sterility assurance level of the products. Healthcare providers and patients must stop using these devices 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

Lithotomy packs are used in medical procedures to support patient positioning and access. They are essential for gynecological surgeries and related healthcare settings.

Why This Is Dangerous

The calibration issues in sterilization equipment raise the risk that these packs may not be sterile, potentially leading to infections during medical procedures.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Patients and healthcare providers must stop using these lithotomy packs, which may cause disruptions in scheduled procedures and potential health risks.

Practical Guidance

How to identify if yours is affected

Check your lithotomy pack model number against DYNJ83185 and DYNJ83185A.
Verify the lot numbers against the recalled list: 23FDC392, 23CDB552, 23CDA474, 22LDA486, 24KDB955.
If your pack matches, cease use immediately.

Where to find product info

Model numbers and lot numbers are typically found on the packaging of the lithotomy packs or in accompanying documentation.

What timeline to expect

Expect a refund processing timeline of 4-6 weeks after submission of your request.

If the manufacturer is unresponsive

Document all communications with Medline.
Re-contact Medline if no response is received within a reasonable period.
Consider filing a complaint with consumer safety authorities if issues persist.

How to prevent similar issues

Always check for recalls on medical devices before use.
Verify sterilization information and certifications when purchasing medical supplies.
Consult with healthcare providers about the safety of devices used in procedures.

Documentation advice

Keep copies of any receipts, correspondence related to the recall, and documentation of your request for a refund.

Product Details

The recall includes two models of lithotomy packs: Model Number DYNJ83185 and DYNJ83185A. The affected products were distributed worldwide, including in the U.S. The kits were sold at an approximate price of $100.

Key Facts

Recall date: January 7, 2026
Quantity recalled: 808 units
Risk of infection due to calibration issues
No incidents reported
Contact Medline for instructions

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

CategoryHealth & Personal Care › Medical Devices

Product TypeLithotomy Pack

Product Details

Brand

Medline Industries, LP

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