HIGH

Medline Recalls Surgical Kits Due to Sterility Assurance Issues

Medline Industries recalled 117,907 surgical convenience kits on January 7, 2026, due to sterilization calibration issues. The recall affects numerous models, including spinal and knee procedure kits. Patients and healthcare providers should 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

Medline surgical convenience kits are used in various surgical procedures to provide essential tools and materials. These kits are commonly purchased by healthcare providers to ensure they have the necessary equipment for specific surgeries.

Why This Is Dangerous

Calibration issues with the sterilization equipment may compromise the sterility of the surgical kits, increasing the risk of infections during surgical procedures. Proper sterilization is critical to patient safety.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

The recall requires immediate action from healthcare providers and patients, potentially causing delays in surgical procedures and impacting patient safety.

Practical Guidance

How to identify if yours is affected

  1. Check the model number of your surgical kit against the recall list
  2. Look for any lot numbers associated with the kit
  3. Verify if your kit is still in use or stored for future procedures

Where to find product info

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

What timeline to expect

Expect a 4-6 week timeline for refund processing once the returned products are received.

If the manufacturer is unresponsive

  • Document all correspondence with Medline regarding the recall
  • Contact the FDA if Medline does not respond within a reasonable time
  • Consider seeking legal advice if you experience complications related to the recalled products.

How to prevent similar issues

  • Always verify the sterilization status of surgical kits before use
  • Purchase surgical kits from reputable manufacturers with strong safety records
  • Stay informed about product recalls through official channels.

Documentation advice

Keep records of your purchase, correspondence with Medline, and any return confirmation for your records.

Product Details

The recall includes models such as CDS940087AG and CDS980832Q, among others. The products were distributed worldwide, including across the US. Prices vary by model.

Key Facts

  • 117,907 units recalled
  • Calibration issues with sterilization equipment
  • Potential risk of infection
  • Stop using immediately and follow manufacturer 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

Product TypeSurgical Convenience Kits
Sold At
Multiple Retailers

Product Details

Model Numbers
1) CDS940087AG
UDI-DI: 10193489847260(each)
40193489847261(case)
Lot Number: 21EBC900
2) CDS940087AI
+9 more
Affected States
ALL
Report Date
February 25, 2026
Recall Status
ACTIVE

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