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
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 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.
Recall announced
August 8, 2025
Reported by FDA DEVICE
October 8, 2025
RecallRadar source check
April 18, 2026
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
- Check model numbers DYNJ0382730O and DYNJ61038B on the kit label.
- Check lot numbers 25GBC583 and 25GBF720 on the packaging.
- 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
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Safety Guide
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