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Medline Recalls Surgical Convenience Kits Over Sterility Issues

Medline Industries recalled 39,315 surgical convenience kits on January 7, 2026. Calibration issues in sterilization equipment may compromise the sterility of these devices. Healthcare providers and patients should stop using these products immediately.

Official notice
Medline Industries, LPHealth & Personal CareMedical Devices1) CDS840015AQUDI-DI: 10195327210144(each)40195327210145(case)

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
January 7, 2026
Status
ACTIVE
Severity
8/10

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

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
Medline Industries, LP
Product type
Surgical Convenience Kits
Model numbers
1) CDS840015AQ, UDI-DI: 10195327210144(each), 40195327210145(case), Lot Number: 23FLA191, 2) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23LBM199 +6 more
Sold at
Multiple Retailers
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    January 7, 2026

  2. Reported by FDA DEVICE

    February 25, 2026

  3. RecallRadar source check

    March 4, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

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

About This Product

Medline's surgical convenience kits are used in various types of surgeries, providing essential tools and supplies. These kits are designed to streamline surgical procedures and improve efficiency in healthcare settings.

Why This Is Dangerous

The calibration issues identified may lead to compromised sterility levels, increasing the risk of infection for patients during surgical procedures. Sterility is crucial in medical settings to prevent post-operative complications.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Failure to address the recall can lead to serious health risks for patients, including potential infections, which can complicate recovery and extend hospital stays.

Practical Guidance

How to identify if yours is affected

  1. Check the model number on your surgical kit packaging or device.
  2. Compare it against the list of recalled model numbers provided by Medline.
  3. Look for any lot numbers mentioned in the recall notice.

Where to find product info

Model numbers and lot numbers are typically found on the packaging or the product label itself.

What timeline to expect

Expect a refund or replacement processing time of approximately 4-6 weeks.

If the manufacturer is unresponsive

  • Contact Medline customer service again for follow-up.
  • Document all correspondence and attempts to reach out.
  • Consider filing a complaint with the FDA if issues persist.

How to prevent similar issues

  • Always verify the sterility of surgical kits before use.
  • Look for certifications on medical products indicating compliance with safety standards.
  • Consult healthcare providers about the safety of medical devices before use.

Documentation advice

Keep all receipts, correspondence, and photos of the recalled product as records for your claims.

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Product Details

The recall affects multiple models, including CDS840015AQ, CDS840023T, and CDS840087AI. These products were distributed worldwide, including across the U.S. The kits are used in various surgical procedures.

Key Facts

  • Calibration issues in sterilization equipment
  • Risk of compromised sterility assurance level (SAL)
  • No reported injuries or incidents

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

Product Details

Model Numbers
1) CDS840015AQ
UDI-DI: 10195327210144(each)
40195327210145(case)
Lot Number: 23FLA191
2) CDS840023T
+9 more
Affected States
ALL
Report Date
February 25, 2026
Recall Status
ACTIVE

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