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Medline Recalls Convenience Kits Over Sterility Concerns

Medline Industries recalled 4,757 convenience kits on January 7, 2026, due to sterilization calibration issues. The recall affects multiple models, raising concerns about sterility assurance levels. Patients and healthcare providers should stop using these products immediately.

Official notice
Medline Industries, LPHealth & Personal CareMedical Devices1) ACC010499UDI-DI: 10193489845709(each)40193489845700(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
Convenience Kits
Model numbers
1) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 25BDB702, 2) ACC010499, Lot Number: 25BDA228, 3) ACC010499, Lot Number: 25ADB705 +4 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 Convenience Kits are pre-packaged medical supplies used in various surgical procedures. These kits are designed for convenience and to ensure that healthcare professionals have essential tools and materials readily available during surgeries.

Why This Is Dangerous

Calibration issues with the sterilization equipment may compromise the sterility of the kits, increasing the risk of infections for patients. Affected products did undergo validated sterilization cycles, but the potential for contamination remains a serious concern.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

This recall affects healthcare providers and patients reliant on these kits for surgical procedures, posing a high risk of infection if contaminated kits are used.

Practical Guidance

How to identify if yours is affected

  1. Check the model number on the convenience kit packaging.
  2. Refer to the recall notification letter for specific details on affected models.
  3. Contact Medline Industries if unsure about your product's status.

Where to find product info

Model numbers are typically located on the product packaging or labeling. Check for a barcode or item number.

What timeline to expect

Expect a timeline of 4-6 weeks for processing refunds or replacements once the product is returned.

If the manufacturer is unresponsive

  • If Medline does not respond promptly, consider contacting the FDA or state health department for assistance.
  • Document all communication attempts and keep records of your return.

How to prevent similar issues

  • Always check for recalls on medical devices prior to purchase.
  • Verify the certifications and safety standards of medical products before use.
  • Consult healthcare providers for the latest information on product safety.

Documentation advice

Keep copies of any correspondence with Medline, receipts from purchases, and photographs of the recalled product.

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Product Details

The recall includes 57 different models of Medline convenience kits. Affected model numbers include ACC010499 and DYKMBNDL117C. These products were distributed worldwide.

Key Facts

  • Recall date: January 7, 2026
  • Quantity recalled: 4,757 units
  • Class II recall classification
  • Stop using the product 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
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
1) ACC010499
UDI-DI: 10193489845709(each)
40193489845700(case)
Lot Number: 25BDB702
2) ACC010499
+7 more
Affected States
ALL
Report Date
February 25, 2026
Recall Status
ACTIVE

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