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Medline Industries Recalls 22 Sterile Convenience Kits DYNJ0382730O, DYNJ61038B (2025)

Medline Industries, LP recalled 22 sterile convenience kits distributed to Florida, Maryland, New Jersey and Tennessee after determining the kits labeled as sterile had not undergone sterilization. The sterility lapse creates an infection risk for patients. Healthcare facilities and patients should stop using the kits and follow the recall instructions from Medline and the FDA.

Official notice

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
August 8, 2025
Status
ACTIVE
Severity
9/10

Quick Facts at a Glance

Recall Date
August 8, 2025
Hazard Level
HIGH
Brand
Medline Industries
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
4 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
Product type
Sterile Convenience Kits
Model numbers
DYNJ0382730O, DYNJ61038B
Sold at
Multiple Retailers
Where affected
FL, MD, NJ, TN

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    August 8, 2025

  2. Reported by FDA DEVICE

    October 8, 2025

  3. RecallRadar source check

    April 18, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

Convenience kits labeled as sterile have not gone through the sterilization process.

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: E-Mail

About This Product

Sterile convenience kits are used to support sterile procedures in clinical settings. These kits are designed to be used in specific medical tasks and are expected to arrive sterile.

Why This Is Dangerous

If labeling is incorrect and the contents are not sterile, patients can be exposed to infection risk during procedures.

Industry Context

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

Real-World Impact

Hospitals and clinics must review inventory immediately. The recall could affect sterile procedures and require substitutions or delays.

Practical Guidance

How to identify if yours is affected

  1. Check model numbers DYNJ0382730O and DYNJ61038B on the kit label.
  2. Check lot numbers 25GBC583 and 25GBF720 on the packaging.
  3. Look for UDI-DI numbers: 10198459117992 (each) for DYNJ0382730O and 10195327596316 (each) for DYNJ61038B.

Where to find product info

Model numbers and UDIs are printed on the kit label and packaging. FDA recall page provides official guidance.

What timeline to expect

Refunds or replacements are typically processed within 4-6 weeks after confirmation of eligibility.

If the manufacturer is unresponsive

  • Escalate to hospital procurement risk management
  • File a consumer complaint with FDA/CDC if a vendor is unresponsive
  • Document all communications and keep records.

How to prevent similar issues

  • Verify sterilization status before use.
  • Purchase sterile kits only from reputable suppliers with clear sterilization certificates.
  • Inspect labels for sterile designation before distribution.
  • Maintain a sterile stock inventory and segregate recalled items.

Documentation advice

Keep the recall notice, take photos of model numbers and lot numbers, save all communications with Medline or distributors.

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Product Details

Model numbers: DYNJ0382730O; DYNJ61038B. Sold to US healthcare facilities in FL, MD, NJ, TN. Sold since: Unknown. Price: Unknown.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 22 total units recalled
  • Model numbers: DYNJ0382730O, DYNJ61038B
  • Lot numbers: 25GBC583, 25GBF720
  • Discontinued distribution in FL, MD, NJ, TN

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
9/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
DYNJ0382730O
DYNJ61038B
Affected States
FL, MD, NJ, TN
Report Date
October 8, 2025
Recall Status
ACTIVE

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