HIGH

Medline Recalls Surgical Kits Over Sterility Assurance Issues

Medline Industries recalled 4,525 surgical convenience kits on January 7, 2026, due to sterilization calibration issues. These problems could compromise sterility assurance levels, posing health risks. 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 Convenience Kits are medical kits designed for surgical procedures, including C-sections. They contain various sterile components necessary for safe surgical practices.

Why This Is Dangerous

The calibration issues with sterilization equipment could lead to compromised sterility, increasing the risk of infections during surgical procedures.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

The recall may cause delays in surgical procedures if hospitals need to replace affected kits, creating both logistical challenges and potential health risks.

Practical Guidance

How to identify if yours is affected

  1. Check the model number of your Medline Convenience Kit against the recalled list.
  2. Look for the UDI-DI and lot number on the packaging.
  3. Verify if your product falls within the specified quantities and dates.

Where to find product info

You can find the serial numbers, UDI-DI, and lot numbers printed on the product packaging and labels.

What timeline to expect

Expect a timeline of 4-6 weeks for refund processing once the return is initiated.

If the manufacturer is unresponsive

  • Document all communication attempts with Medline.
  • Reach out to the FDA for assistance if necessary.

How to prevent similar issues

  • Ensure future purchases include verification of sterilization certifications.
  • Research the manufacturer's quality controls before purchasing medical devices.
  • Always check for recalls on medical products before use.

Documentation advice

Keep receipts, correspondence with Medline, and any documentation regarding your product return for your records.

Product Details

The recall affects 36 models of Medline Convenience Kits, including C-SECTION PACK models CDS820080N and CDS983523G. These kits were distributed worldwide, including across the U.S., and sold to hospitals and healthcare providers.

Key Facts

  • Recall date: January 7, 2026
  • Total units recalled: 4,525
  • Issue: Sterilization calibration problems
  • Distribution: Worldwide
  • Action required: Stop using immediately

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
7/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
1) CDS820080N
UDI-DI: 10195327278014(each)
40195327278015(case)
Lot Number: 23IMB818
2) CDS983523G
+11 more
Affected States
ALL
Report Date
February 25, 2026
Recall Status
ACTIVE

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