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 Kits
- Model numbers
- Medline Kit SKU CDS984853L: UDI/DI 10198459293535 (EA) 40198459293536 (CS), Lot Number 25KMI898, Medline Kit SKU DYNJ45641B: UDI/DI 10193489494921 (EA) 40193489494922 (CS), Lot Number 25KMH748, Medline Kit SKU DYNJT3658A: UDI/DI 10198459354007 (EA) 40198459354008 (CS), Lot Number 25KME009.
- 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
The Medline medical procedure convenience kits are designed for healthcare professionals to streamline various medical procedures. They are used in settings like hospitals and clinics for tasks such as biopsies and dermatological treatments.
Why This Is Dangerous
The hazard arises from the MASTISOL adhesive, which is integral to the kits. If the butyrate tubing cracks during use, it can lead to exposure to potentially harmful substances.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers may face delays in medical procedures due to the recall. The urgency of the recall reflects significant safety concerns that could affect patient health.
Practical Guidance
How to identify if yours is affected
- Check the SKU numbers on your medical kits against the recall list.
- Look for the lot numbers: 25KMI898, 25KMH748, or 25KME009.
- Confirm if the kits contain MASTISOL liquid adhesive.
Where to find product info
SKU and lot numbers are typically found on the packaging or product label of the kits.
What timeline to expect
Expect a refund processing time of 4-6 weeks after returning the product.
If the manufacturer is unresponsive
- Document all correspondence with Medline.
- Follow up via phone if you do not receive a response within a week.
- Consider filing a complaint with the FDA if the issue persists.
How to prevent similar issues
- Verify product recalls before purchase using FDA resources.
- Look for safety certifications on medical devices before buying.
- Consult with healthcare professionals about product reliability.
Documentation advice
Keep records of your purchase, including receipts and any correspondence with Medline regarding the recall.
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Product Details
The recall affects three Medline medical procedure convenience kits: 1) BREAST-HERNIA-PORT CDS-LF, Kit SKU CDS984853L; 2) BREAST BIOPSY PACK, Kit SKU DYNJ45641B; 3) DERMATOLOGY PACK, Kit SKU DYNJT3658A. These kits were distributed nationwide in the United States.
Key Facts
- Recall date: December 12, 2025
- Total units recalled: 1,928
- Distribution: US Nationwide
- Manufacturer: Medline Industries, LP
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Safety Guide
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