HIGH

Medline Recalls Surgical Kits Over Sterility Concerns

Medline Industries recalled 12,418 surgical kits on January 7, 2026, after identifying calibration issues in sterilization equipment. The defects could compromise sterility assurance levels of the devices. Healthcare providers and patients must stop using the affected 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 surgical kits are designed for various medical procedures, primarily in gynecology and urology. These kits include essential tools and instruments needed for surgeries, ensuring that healthcare providers have everything required for safe operations.

Why This Is Dangerous

Calibration issues in the sterilization equipment could lead to a failure in achieving the expected sterility assurance level (SAL) for the kits. This failure increases the risk of infection or complications during surgical procedures.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

The recall affects patient safety and may lead to delays in scheduled surgeries while healthcare providers identify and remove affected kits from use.

Practical Guidance

How to identify if yours is affected

  1. Locate the model number on your surgical kit packaging.
  2. Compare the model number against the recalled models list provided by Medline.
  3. Contact your healthcare provider if you are unsure about your kit.

Where to find product info

Model numbers can typically be found on the product packaging or the accompanying documentation.

What timeline to expect

Expect a response from Medline within a few weeks regarding refund or replacement options.

If the manufacturer is unresponsive

  • Document all attempts to contact Medline.
  • Reach out to your healthcare provider for assistance.
  • Consider filing a complaint with the FDA if no response is received.

How to prevent similar issues

  • Ensure that surgical kits are sourced from reputable manufacturers.
  • Check for recent recalls or safety notices before purchasing medical devices.
  • Look for certifications showing compliance with sterilization standards.

Documentation advice

Keep records of your purchase, including receipts and any correspondence regarding the recall.

Product Details

The recall affects multiple models of Medline surgical kits, including ROBOTIC GYN CDS-1 (Model CDS982893I) and GYN LAPAROSCOPY CDS (Model CDS983300J). These kits were widely distributed in the U.S. and internationally.

Key Facts

  • Recall date: January 7, 2026
  • Quantity recalled: 12,418 units
  • Distribution: Worldwide
  • Class II recall due to high hazard level
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 TypeSurgical Kits
Sold At
Multiple Retailers

Product Details

Model Numbers
1) CDS982893I
UDI-DI: 10889942208050(each)
40889942208051(case)
Lot Number: 24IBO240
2) CDS983300J
+11 more
Affected States
ALL
Report Date
February 25, 2026
Recall Status
ACTIVE

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