Class II U.S. Food and Drug Administration

Medline medical procedure convenience kits labeled as: 1) Depaul Basic recall: Medline kits were manufactured and distributed containing MASTISOL liquid

Recall published 9 months ago

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.

The hazard: Device safety concern

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

What the notice says: 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.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-1196-2026
Published
February 4, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Medline Industries, LP
Product type
Medical devices
Units affected
236 units
Distribution
Nationwide
Made in
United States
Lot / code info
Medline Kit SKU DYNJ20028L: UDI/DI 10198459228995 (EA) 40198459228996 (CS), Lot Number 25LMA824; Medline Kit SKU DYNJ46546M: UDI/DI 10198459526404 (EA) 40198459526405 (CS), Lot Number 25KMH940; Medline Kit SKU DYNJ54396K: UDI/DI 10198459443138 (EA) 40198459443139 (CS), Lot Number 25KMD804; Medline Kit SKU DYNJ59397Q: UDI/DI 10198459495427 (EA) 40198459495428 (CS), Lot Number 25KMC287; Medline Kit SKU DYNJ904052L: UDI/DI 10198459231339 (EA) 40198459231330 (CS), Lot Number 25JDB033; Medline Kit SKU DYNJT6428: UDI/DI 10198459553660 (EA) 40198459553661 (CS), Lot Number 25KMD463.
UPC codes
10198459228995, 40198459228996, 10198459526404, 40198459526405, 10198459443138, 40198459443139, 10198459495427, 40198459495428, 10198459231339, 40198459231330, 10198459553660, 40198459553661

Products covered by this recall

Medline medical procedure convenience kits labeled as: 1) DEPAUL BASIC NEURO-LF, Kit SKU DYNJ20028L; 2) NEURO MINOR PACK, Kit SKU DYNJ46546M; 3) NEURO SHUNT PACK, Kit SKU DYNJ54396K; 4) NEURO PACK, Kit SKU DYNJ59397Q; 5) NEURO BASIC, Kit SKU DYNJ904052L; 6) PK NEURO SHUNT BUMC, Kit SKU DYNJT6428.

Check your product

The notice names 24 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 10198459228995
  • 40198459228996
  • 10198459526404
  • 40198459526405
  • 10198459443138
  • 40198459443139
  • 10198459495427
  • 40198459495428
  • 10198459231339
  • 40198459231330
  • 10198459553660
  • 40198459553661

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 25LMA824
  • 25KMH940
  • 25KMD804
  • 25KMC287
  • 25JDB033
  • 25KMD463. — 236 units

Model or item number

On the rating label, the box or the instruction sheet.

  • DYNJ20028L
  • DYNJ46546M
  • DYNJ54396K
  • DYNJ59397Q
  • DYNJ904052L
  • DYNJT6428

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Medline Industries, LP — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  3. Ask the supplier or clinic that provided it what the remedy is in your case.
  4. If you are a facility, quarantine affected stock and log the correction.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

Company contact: Medline Industries, LP — 3 Lakes Dr, Northfield, IL, 60093-2753

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Medline Industries, LP medical devices recalled?

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. 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.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 10198459228995, 40198459228996, 10198459526404; lot code 25LMA824, 25KMH940, 25KMD804; model number DYNJ20028L, DYNJ46546M, DYNJ54396K. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

Where was the recalled product sold?

It was distributed nationwide.

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