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 DYNJ0395022O: UDI/DI 10195327634827 (EA) 40195327634828 (CS), Lot Number 25KME682, Medline Kit SKU DYNJ0415776Q: UDI/DI 10198459566806 (EA) 40198459566807 (CS), Lot Number 25KMH125, Medline Kit SKU DYNJ04811O: UDI/DI 10198459440953 (EA) 40198459440954 (CS), Lot Number 25KMD772, Medline Kit SKU DYNJ44864S: UDI/DI 10195327127626 (EA) 40195327127627 (CS), Lot Number 25LMA115 +8 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 contain essential tools and materials for various surgical procedures. Healthcare providers use these kits to ensure efficient and safe operations.
Why This Is Dangerous
The defect in the MASTISOL adhesive's butyrate tubing can lead to cracking during use, which can compromise patient safety during medical procedures.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects healthcare providers who must stop using the kits, potentially delaying procedures and creating an urgent need for safe alternatives.
Practical Guidance
How to identify if yours is affected
- Locate the SKU number on your kit.
- Compare your SKU to the affected SKUs listed in the recall.
- Check the lot number for additional verification.
Where to find product info
SKU numbers and lot numbers are typically found on the packaging or the product label.
What timeline to expect
Expect a refund or replacement processing time of 4-6 weeks after returning the product.
If the manufacturer is unresponsive
- Follow up with Medline Industries via phone or email.
- Document all correspondence regarding your request.
How to prevent similar issues
- Look for medical kits that specify non-toxic adhesives.
- Check for certifications from health and safety organizations.
- Avoid purchasing kits without clear safety information.
Documentation advice
Keep receipts, email correspondence with Medline, and any photos of the product for your records.
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Product Details
The recalled kits include: RR-GYN LAPAROSCOPY PACK-LF (SKU DYNJ0395022O), PELVISCOPY PACK-LF (SKU DYNJ0415776Q), DIVA PACK (SKU DYNJ04811O), DA VINCI PROSTATE/COLPOPEXY (SKU DYNJ44864S), MH ROBOTICS PACK (SKU DYNJ50880L), DELNOR LAPAROSCOPIC GYN PACK (SKU DYNJ82244B), ROBOT PACK (SKU DYNJ82761B), and GENERAL ROBOTICS PACK (SKU DYNJT4964). These kits were distributed nationwide in the U.S.
Key Facts
- Hazard: Cracked tubing in adhesive vials
- Stop using immediately
- Contact Medline for instructions
- Nationwide distribution in the U.S.
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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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