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 DYNJ0972604A: UDI/DI 10889942403905 (EA) 40889942403906 (CS), Lot Number 25KMD144, Medline Kit SKU DYNJ33822L: UDI/DI 10198459385582 (EA) 40198459385583 (CS), Lot Number 25KMD419, Medline Kit SKU DYNJ45640B: UDI/DI 10193489494983 (EA) 40193489494984 (CS), Lot Number 25KMD793, Medline Kit SKU DYNJ63377D: UDI/DI 10198459514579 (EA) 40198459514570 (CS), Lot Number 25KMI988 +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 are used in various healthcare settings for procedures requiring sterile equipment. These kits are valued for their convenience and comprehensive supply of necessary tools.
Why This Is Dangerous
The hazard arises from the MASTISOL liquid adhesive which is contained in the kits. The butyrate tubing can crack during use, potentially leading to failures during medical procedures.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall may cause inconvenience for healthcare providers relying on these kits for medical procedures, with potential safety risks if the defective kits are used.
Practical Guidance
How to identify if yours is affected
- Check the SKU and lot numbers against the recall notice.
- Verify if your kit is one of the affected models listed.
- Look for the UDI/DI numbers on the packaging.
Where to find product info
The SKU and lot numbers can typically be found on the kit packaging or documentation included with the product.
What timeline to expect
Expect a refund or replacement processing time of 4-6 weeks after returning the kits.
If the manufacturer is unresponsive
- Document all communication attempts with Medline.
- Contact regulatory bodies if no response is received within a reasonable timeframe.
- Consider filing a complaint with the FDA if necessary.
How to prevent similar issues
- Ensure future purchases are from reputable suppliers with good safety records.
- Look for products that have been certified by health and safety regulatory bodies.
- Stay informed about product recalls in the medical device category.
Documentation advice
Keep records of any correspondence with Medline, including dates, times, and content of discussions regarding the recall.
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Product Details
The recall includes the following kits: PACER / CATH LAB PACK-LF (SKU DYNJ0972604A), PACEMAKER/ICD PACK (SKU DYNJ33822L), and VENOUS ACCESS PACK (SKU DYNJ45640B), among others. These kits were distributed nationwide in the U.S.
Key Facts
- Recall date: December 12, 2025
- Report date: February 4, 2026
- Total kits recalled: 1,928
- Hazard level: High
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Safety Guide
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