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Medline Convenience Kits Recalled Over Sterility Issues

Medline Industries, LP recalled 154,427 Convenience Kits on January 7, 2026. The recall stems from calibration issues with sterilization equipment, potentially affecting sterility assurance. Patients and healthcare providers should stop using the affected products immediately.

Official notice
Medline Industries, LPHealth & Personal CareMedical Devices1) ACC010326UDI-DI: 10889942735525(each)40889942735526(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) ACC010326, UDI-DI: 10889942735525(each), 40889942735526(case), Lot Number: 22HDA973, 2) ACC010326, Lot Number: 22BDB172, 3) ACC010326, Lot Number: 21LDA438 +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 designed for various surgical and medical procedures. These kits are commonly used in hospitals and healthcare settings to ensure that all necessary equipment is readily available for clinicians.

Why This Is Dangerous

Calibration issues in the sterilization equipment may compromise the sterility of the contents in the kits, leading to increased risk of infections for patients.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

The recall impacts healthcare providers and patients, as using compromised kits may lead to serious health risks. Immediate cessation of use is necessary to prevent potential infections.

Practical Guidance

How to identify if yours is affected

  1. Check the model number on the product packaging.
  2. Refer to the recall announcement for a complete list of affected model numbers.
  3. Verify the lot number associated with your kit if applicable.

Where to find product info

The model number and lot number can typically be found on the product packaging or the labeling on the kit.

What timeline to expect

Expect a processing timeline of approximately 4-6 weeks for refunds after the return of the recalled product.

If the manufacturer is unresponsive

  • Contact Medline's customer service for assistance.
  • Document all interactions with the company regarding your recall inquiry.

How to prevent similar issues

  • Look for FDA-approved sterile medical kits in the future.
  • Ensure products are from reputable manufacturers with a history of safety compliance.
  • Check for recall notices before purchase.

Documentation advice

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

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Product Details

The recalled products include various models such as ACC010326, ACC010326A, and CDS860063U among others. The kits were distributed worldwide, primarily across the United States. Retail prices for these medical kits vary widely depending on the specific kit.

Key Facts

  • Calibration issues noted
  • Stop using immediately
  • Contact Medline for instructions

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) ACC010326
UDI-DI: 10889942735525(each)
40889942735526(case)
Lot Number: 22HDA973
2) ACC010326
+7 more
Affected States
ALL
Report Date
February 25, 2026
Recall Status
ACTIVE

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