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Medline Convenience Kits Recalled Due to Sterility Concerns

Medline recalled 108 units of its Convenience Kits, model DYKMBNDL200A, due to calibration issues affecting sterility. The recall, issued on January 7, 2026, impacts products distributed worldwide. Healthcare providers and patients must stop using the kits immediately.

Official notice
Medline Industries, LPHealth & Personal CareMedical Devices1) DYKMBNDL200AUDI-DI: 10195327240592(each)40195327240593(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 Kit
Model numbers
1) DYKMBNDL200A, UDI-DI: 10195327240592(each), 40195327240593(case), Lot Number: 25HBD027, 2) DYKMBNDL200A, Lot Number: 25FBD161, 3) DYKMBNDL200A, Lot Number: 25EBN454 +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 used in healthcare settings for various medical procedures requiring sterile supplies. They provide necessary items in a single package for convenience and efficiency during procedures.

Why This Is Dangerous

Calibration issues with sterilization equipment can lead to inadequate sterilization of the kits. This increases the risk of infection and other complications for patients.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Consumers must stop using these kits to avoid potential health risks. The recall may cause inconvenience to healthcare providers and patients relying on these supplies.

Practical Guidance

How to identify if yours is affected

  1. Locate the model number on the packaging or product label.
  2. Check the lot numbers against those listed in the recall notice.
  3. If your kit matches the recalled model or lot number, it is affected.

Where to find product info

The model number and lot numbers can typically be found on the product packaging or product insert.

What timeline to expect

Expect a refund or replacement processing time of 4-6 weeks after following the return instructions provided by Medline.

If the manufacturer is unresponsive

  • Document all communications with Medline regarding the recall.
  • Follow up via customer service phone or email if you do not receive a response within a week.
  • Consider filing a complaint with the FDA if issues persist.

How to prevent similar issues

  • Always check for recalls on medical devices before use.
  • Look for products with clear sterilization certifications and quality assurance marks.
  • Be cautious of expired or compromised medical supplies.

Documentation advice

Keep copies of receipts, correspondence with Medline, and any documentation regarding the recall for your records.

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Product Details

The recalled product is Medline Convenience Kits, model DYKMBNDL200A. The kits were distributed worldwide, including the US, and the recall affects 108 units.

Key Facts

  • Recalled model: DYKMBNDL200A
  • Recall issued January 7, 2026
  • 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
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
1) DYKMBNDL200A
UDI-DI: 10195327240592(each)
40195327240593(case)
Lot Number: 25HBD027
2) DYKMBNDL200A
+7 more
Affected States
ALL
Report Date
February 25, 2026
Recall Status
ACTIVE

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