Quick Facts at a Glance
- Recall Date
- December 12, 2025
- 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
- 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, LP
- Product type
- Medical Procedure Convenience Kits
- Model numbers
- Medline Kit SKU CDS984347O: UDI/DI 10198459311451 (EA) 40198459311452 (CS), Lot Number 25KMD733, Lot Number 25KMC147, Medline Kit SKU CDS984857N: UDI/DI 10198459359705 (EA) 40198459359706 (CS), Lot Number 25KMJ151, Medline Kit SKU DYNJ0966130K: UDI/DI 10198459442117 (EA) 40198459442118 (CS), Lot Number 25LMB220, Lot Number 25KME804 +9 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 12, 2025
Reported by FDA DEVICE
February 4, 2026
RecallRadar source check
April 13, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
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: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
About This Product
Medline medical procedure convenience kits provide essential tools for various medical procedures. These kits are often used in clinical settings where quick access to medical supplies is vital for patient care.
Why This Is Dangerous
The MASTISOL liquid adhesive included in these kits can have defective tubing that may crack during use. This defect can lead to product failure, potentially impacting medical procedures.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers should stop using the affected kits to avoid any risks during medical procedures. This recall may cause inconvenience to healthcare providers relying on these kits for patient care.
Practical Guidance
How to identify if yours is affected
- Check the SKU numbers against the recall list.
- Verify the lot numbers mentioned in the recall notice.
- Contact Medline Industries if uncertain about the product's status.
Where to find product info
SKU and lot numbers are typically found on the packaging of the kits or on the product label inside.
What timeline to expect
Expect a refund processing time of approximately 4-6 weeks after returning the product.
If the manufacturer is unresponsive
- Follow up with Medline Industries via phone or email.
- Document all communications for your records.
- Consider contacting regulatory authorities if no response is received.
How to prevent similar issues
- Always check for recalls before using medical equipment.
- Purchase from reputable suppliers that provide recall information.
- Look for certifications and safety standards when selecting medical supplies.
Documentation advice
Keep records of your purchase, including receipts and correspondence regarding the recall.
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Product Details
The recall includes the following kits: MIDDLE EAR CDS (SKU CDS984347O), HEAD AND NECK CDS-LF (SKU CDS984857N), NECK PACK-LF (SKU DYNJ0966130K), and others. These kits were distributed nationwide.
Key Facts
- Recall date: December 12, 2025
- 40 units recalled nationwide
- Affected kits include MIDDLE EAR CDS and HEAD AND NECK CDS-LF
- Stop use immediately and follow manufacturer instructions
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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