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Medline Sterile Radiology Procedure Kits Recalled for Sterility Breach (2026)

Medline Industries recalled 420 Sterile Radiology Procedure Kits, Model DYNDH1491B, distributed nationwide in Minnesota after a potential breach in sterile pouch packaging. The defect may compromise product sterility. Stop using the kit immediately and contact Medline or your healthcare provider for instructions.

Official notice
Medline Industries, LPHealth & Personal CareMedical DevicesDYNDH1491BUDI-DI: CS 40198459071455EA: 10198459071454

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
February 18, 2026
Status
ACTIVE
Severity
7/10

Quick Facts at a Glance

Recall Date
February 18, 2026
Hazard Level
HIGH
Brand
Medline Industries, LP
Category
Health & Personal Care
Sold At
Unknown
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
Sterile Radiology Procedure Kit
Model numbers
DYNDH1491B, UDI-DI: CS 40198459071455, EA: 10198459071454, Lot Number: 25GBB924
Sold at
Unknown
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    February 18, 2026

  2. Reported by FDA DEVICE

    April 8, 2026

  3. RecallRadar source check

    April 15, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

There is a potential breach in the sterile pouch packaging for one lot of radiology kits, which may compromise product sterility.

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

Sterile radiology procedure kits are used to prepare and maintain a sterile field during radiology imaging procedures. They are intended for use in hospital and clinical settings.

Why This Is Dangerous

A breach in the sterile pouch packaging can allow microbial contamination of the kit contents. Using such a kit could lead to infection or other procedure-related complications.

Industry Context

This recall is not described as part of a broader industry pattern.

Real-World Impact

Healthcare facilities may need to quarantine the affected lot and assess patient procedures that used the kit. The impact is primarily clinical and operational, with potential infection risk for patients.

Practical Guidance

How to identify if yours is affected

  1. 1) Locate your kit packaging and identify the lot number 25GBB924.
  2. 2) Confirm the model DYNDH1491B is present on the product label.
  3. 3) If the lot matches, quarantine the kit and discontinue use.

Where to find product info

Serial numbers and lot numbers are printed on the kit packaging and outer box. Use the FDA recall page for official identifiers.

What timeline to expect

Refund or replacement process is determined by Medline Industries, LP; expect weeks to several weeks.

If the manufacturer is unresponsive

  • Document all attempts to contact the manufacturer.
  • Escalate to your hospital's risk management or infection control if urgent.
  • If necessary, file a consumer complaint with FDA recall processes.

How to prevent similar issues

  • Inspect sterile packaging before use.
  • Keep track of batch/lot numbers for all sterile kits.
  • Source sterile kits from reputable suppliers with clear recall notification processes.

Documentation advice

Retain recall notification, take photos of packaging and label, maintain records of all communications with supplier and healthcare providers.

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Product Details

Model: DYNDH1491B. UDI-DI: CS 40198459071455. EA code: 10198459071454. Lot number: 25GBB924. Brand: Medline Industries, LP. Quantity: 420 units. Distribution: US nationwide, MN. Recall date: 2026-02-18. Status: ACTIVE. Country of origin: Unknown.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • Lot number 25GBB924 identified
  • Model DYNDH1491B
  • One lot distribution MN within US nationwide
  • High-hazard, potential sterility breach
  • No injuries reported

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
7/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
DYNDH1491B
UDI-DI: CS 40198459071455
EA: 10198459071454
Lot Number: 25GBB924
Affected States
ALL
Report Date
April 8, 2026
Recall Status
ACTIVE

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