HIGHFDA DEVICE

Medline Convenience Kits Recalled Due to Sterility Issues

Medline Industries has recalled 779 units of its Convenience Kits due to calibration issues with sterilization equipment. The recall affects multiple model numbers including DYNJ56436A and DYNJ56436B. Consumers should stop using these products immediately and follow recall instructions.

Official notice
Medline Industries, LPHealth & Personal CareMedical Devices1) DYNJ56436AUDI-DI: 10889942749874(each)40889942749875(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) DYNJ56436A, UDI-DI: 10889942749874(each), 40889942749875(case), Lot Number: 21BMC737, 2) DYNJ56436A, Lot Number: 21AMB799, 3) DYNJ56436B, UDI-DI: 10193489869569(each) +8 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 medical supplies used for pain management and surgical procedures. They are designed to ensure patient safety and comfort during medical treatments.

Why This Is Dangerous

Calibration issues with the sterilization equipment could lead to inadequate sterilization of the devices, risking patient safety due to potential exposure to pathogens.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Consumers using these kits should stop immediately to avoid health risks, impacting patient treatment and safety.

Practical Guidance

How to identify if yours is affected

  1. Check the model number on the product packaging or device.
  2. Verify the lot number against the recall notice.
  3. Look for the UDI-DI numbers on the product labels.

Where to find product info

Model numbers and lot numbers can typically be found on the product packaging or the device itself.

What timeline to expect

Expect refund processing to take approximately 4-8 weeks after initiating the return.

If the manufacturer is unresponsive

  • Document all communication attempts with Medline.
  • Reach out to the FDA or your healthcare provider for assistance.

How to prevent similar issues

  • Purchase medical supplies from reputable suppliers with clear safety certifications.
  • Look for recalls or safety alerts before using medical devices.
  • Ensure that products are labeled sterile before use.

Documentation advice

Keep a record of your purchase, including receipts and any correspondence related to the recall.

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Product Details

The recalled models include SCC RF PAIN MGMT, Model Numbers: DYNJ56436A, DYNJ56436B, and CPNB SETUP TRAY, Model Numbers: DYNJRA1979, DYNJRA1979A, SAMPA0108. These products were distributed worldwide, including throughout the United States.

Key Facts

  • Recalled models include DYNJ56436A, DYNJ56436B, DYNJRA1979
  • 779 units recalled due to calibration issues
  • Stop using the devices immediately
  • Contact Medline for further 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) DYNJ56436A
UDI-DI: 10889942749874(each)
40889942749875(case)
Lot Number: 21BMC737
2) DYNJ56436A
+11 more
Affected States
ALL
Report Date
February 25, 2026
Recall Status
ACTIVE

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