Quick Facts at a Glance
- Recall Date
- August 8, 2025
- Hazard Level
- HIGH
- Brand
- Medline Industries
- Category
- Health & Personal Care
- Sold At
- Unknown
- 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
- Extremity Pack Convenience Kit
- Model numbers
- 1) DYNJ45701B, UDI-DI: 10193489856279(each), 40193489856270(case), Lot Number: 25GBF686
- Sold at
- Unknown
- 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 Extremity Pack kits are used in healthcare settings to organize sterile items for procedures. They are intended for use in hospitals or clinics.
Why This Is Dangerous
If a kit is labeled sterile but not sterilized, contents may be contaminated and pose an infection risk to patients.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Hospitals and clinics may need to halt use of affected kits, potentially delaying procedures and increasing waste.
Practical Guidance
How to identify if yours is affected
- Verify model: DYNJ45701B
- Check UDI-DI: 10193489856279(each)
- Check case UDI: 40193489856270
- Check Lot Number: 25GBF686
- Inspect packaging for sterile labeling
- If affected, stop use immediately and follow recall instructions
Where to find product info
Recall details available at the FDA enforcement page for Z-2593-2025. Official Medline recall communications will be issued to healthcare providers.
What timeline to expect
Recall processing times vary; replacements or refunds will be communicated by Medline and may take several weeks.
If the manufacturer is unresponsive
- Document all contact attempts with Medline.
- Escalate to hospital risk management or patient safety officers.
- Consider filing with FDA recall portals if available.
How to prevent similar issues
- Verify sterility status before procurement
- Ask suppliers for Sterility Assurance Documentation
- Check packaging for intact seals and lot numbers
- Prefer suppliers with robust recall notification systems
Documentation advice
Keep copies of all recall notices, packaging, labels, model/UDI numbers, and correspondence with Medline.
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Product Details
Model numbers: 1) DYNJ45701B. UDI-DI: 10193489856279(each). Case UDI: 40193489856270. Lot Number: 25GBF686. Quantity: 88 units. Distribution: US to FL, MD, NJ, TN. Sold to healthcare facilities in the United States. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Model DYNJ45701B
- States affected: FL, MD, NJ, TN
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Safety Guide
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